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FDA Warns Taiwan Drugmaker Over GMP Violations

FDA

The US Food and Drug Administration (FDA) last month warned Taipei, Taiwan-based drugmaker Vida International over good manufacturing practice (GMP) violations following an inspection of the company’s Taoyuan City facility last December.

As a result of the observations made during the inspection, FDA placed Vida on import alert in March.

In the warning letter, FDA cites Vida for failing to conduct necessary batch testing for one of its products before release.

“You released an over-the-counter (OTC) drug product [redacted] to the US supply chain without testing the identity, strength, purity, and other quality of the active ingredient. In addition, you did not adequately test for critical microbial attributes (e.g., absence of objectionable microorganisms, total count) before release,” FDA writes.

FDA also says the firm failed to test incoming raw materials, including active ingredients, to determine their identity and whether they conform to written specifications before use.

According to FDA, Vida also prepared an inaccurate batch record for a lot of one of its drugs that did “not represent the formula and ingredients that the product purports on its label.”

FDA says the batch record did not list all the active ingredients specified on the drug’s label and did not include “the actual amounts of each active and inactive ingredient used during manufacturing, a calculation of theoretical or actual yields, documentation of the equipment used, and [other] critical manufacturing parameters.”

Additionally, FDA says the company failed to establish an adequate quality control unit, noting that the firm lacked adequate written procedures for functions, such as the release of batches and overseeing its drug stability program.

While Vida provided a response to FDA in December, the agency says the response is inadequate and requests that the company provide a plan for testing samples of all batches of drugs distributed to the US and conduct a risk assessment for all products distributed to the US within expiry to estimate the impact of its testing lapses.

They also asks the company to clarify whether it intends to resume manufacturing drugs at the facility for the US market, and if so to provide additional information on test methods and specifications and batch release specifications. Furthermore, FDA says the company will need to put in place corrective and preventative action (CAPA) plans to address deficiencies related to its stability program and quality control unit.

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REGULATORY BODIES

A Regulatory Body (also regulatory authority, regulatory agency or regulator) is a public authority or government agency. It is responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity.

An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the  government. Regulatory authorities are commonly set up to enforce safety and standards.  Certainly to protect consumers in markets where there is a lack of effective competition or the potential for the undue exercise of market power.

Examples of regulatory agencies that enforce standards are :

Food and Drug Administration in the United States and the Medicines.

Healthcare Products Regulatory Agency in the United Kingdom.

SOURCE : WIKIPEDIA

Although regulatory affairs is real regulatory body for the  process but other departments are co-related too .
1 – Quality Control
2 – Quality Assurance
3 – Regulatory Affairs

Quality Control

Quality control (QC) is a process by which entities review the quality of all factors involved in production. Most noteworthy ” A part of quality management focused on fulfilling quality requirements.”

This approach places an emphasis on three aspects :

Elements such as controls, job management, defined and well managed processes, performance and integrity criteria. It also helps in  identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organisational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analysed).

Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.

the Quality Control operates a stringent system for release testing of raw materials, packaging materials, in process controls and final products through the use of the most modern analytical techniques and equipment supported by highly trained and experienced personnel. QC also undertake reference standard certification in compliance with cGMP regulations.

Quality Assurance

Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention.

This can be contrasted with quality control, which is focused on process output.
the Quality Assurance, independent of production, is responsible for the maintenance, compliance and further development of our internal quality management system. The Quality Assurance group guarantees that the pharmaceutical ingredients and other products comply with the respective requirements and are developed, produced, tested and released according to cGMP demands.

regulatory body

Regulatory Affairs

RA department assist clients with regulatory filing processes by providing full support in the compilation and maintenance of regulatory documentation. Hence it includes chemistry, manufacturing and control documentation, post-approval change documentation, type II Drug Master Files (DMFs), Certifications of Suitability to the Monographs of the European Pharmacopoeia (CEPs) and Active Substance Master Files for Europe (ASMFs).

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What is Regulatory Intelligence (RI)?

regulatory intelligence
REGULATORY INTELLIGENCE (RI)

If we will search for REGULATORY INTELLIGENCE anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation.

Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities:

  • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material.
  • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to latest trends and patterns in the regulatory industry. Latest changes in regulatory and guidelines need to be implemented.
  • Regulatory Strategy: The key purpose to perform the above stated undertakings is to come up with the most appropriate and practical regulatory strategy for a company. Different products have different regulatory guidelines in different countries. This is why experts propose a plan of action that outlines an approach as to how to go about regulatory actions for the target distribution markets. However this plan of action is never a task done. It continuously goes forward as the mandates in the regulatory space change.

PHARMA ACTD DOSSIERS
REGULATORY INTELLIGENCE (RI)

This function of REGULATORY INTELLIGENCE(RI) typically conducts the following activities:


• Regulatory strategy, development plan or therapeutic area analysis for a product.
• Guidance interpretation and application.
• Due diligence
• Citizen’s Petitions
• Participation or observation of Advisory Committee or other public meetings.
• Identifying regulatory trends and anticipating effect on company and products.
• Monitoring health authority organisational changes.
• White papers or position statements.

Why is Regulatory Intelligence Important?


Provides the regulatory professional with information to:


– Identify opportunities.
• Broader indications, precise pre‐clinical/clinical development programs.
• Expedite development/increase efficiency.
– Identify possible pitfalls.
• Compliance issues, change in requirements for specific indication.
– Predict review times for product and/or change to product.
– Answer specific development questions posed by team.

USERS OF RI
USERS OF REGULATORY INTELLIGENCE (RI)

Benefits of Regulatory Intelligence (RI)
• Increased compliance.
• Increase likelihood of marketing application approval.
• Shorten time from filing to approval.
• Increased efficiency.
• Optimise study design for regulatory endpoints.
• Optimise messaging about product benefit.
• Maximise target market potential.
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Regulatory Strategy

strategy

First of all a therapeutic product’s regulatory strategy is a key component of product development. It is important that the regulatory strategy be developed very early in the drug-development process. As soon as the target product profile (TPP) has been determined, the regulatory strategy can be worked out as a pathway to support the TPP. The regulatory strategy is a reverse-engineered document such that once one has developed a TPP (i.e., the objective is established), one can then work backward to determine what information is needed to achieve the goal.

Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. furthermore this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The clinical trial program should support the regulatory strategy. In other words, if the outcome of a clinical trial is not providing information that is supportive or pivotal to a future marketing application, its value should be questioned — at least in the early stages of drug development or in situations where cost plays a major role.
The main activities involved in creating and achieving a regulatory strategy include:

• conducting intelligence-gathering activities
• obtaining and managing documentation
• obtaining necessary approvals to conduct pre-clinical and clinical studies
• preparing for and attending regulatory authority meetings
• planning, preparing and maintaining regulatory submissions and correspondence
• responding to Agency queries and deficiency letters

Importance of the label and label claims
As part of the target product profile, a draft label will have been prepared. This will list the main proposed claims of the manufacturer. The regulatory strategy can then be developed to support these claims. Thus the TPP dictates key aspects of the clinical trial program.

Key aspects of a good regulatory strategy

A good regulatory strategy involves understanding the key guidelines and emerging policies, as well as the relevant stakeholders that stand between drug development and drug approval.

A good regulatory strategy identifies the pathway and the potential hurdles, and creates a plan that will proactively address any issues that may arise. A good regulatory strategy includes potential regulatory solutions for possible roadblocks.
Novel approaches or drugs with new mechanisms of action can present opportunities. With ongoing developments in science and medicine, the landscape continues to evolve and it is important for regulatory affairs professionals to engage an educational approach with regulators. Those who best understand a new drug are usually those who have developed it.

Thus it can be critical to educate regulatory agencies on how a drug or its mechanism may be unique, and that the existing regulatory guidelines and policies may not necessarily directly apply. Novel endpoints may be needed if the indication is new. This can pose challenges for drug development, but also it presents an opportunity to potentially identify new benefits and new strategies for obtaining marketing authorization.

Based upon the needs of regulators, a good regulatory affairs professional needs to be able to carefully evaluate development options and potential issues and challenges. The regulatory affairs professional is the communications intermediary between regulators and the rest of the drug development and marketing team. These individuals should be key members of the drug development team in order to best address any potential issues with regulators.
Regulatory strategy document
The regulatory strategy document has three main purposes. It needs to be:

• The tracking tool to summarize key agreements reached with health authorities
• The planning tool that documents timelines and lists topics to address in future meetings with health authorities
• The risk register to record key issues that could impact timelines, costs or commercial value for the project

Key components of a regulatory practices could include:

• A summary of relevant guidelines and precedents
• a strategy to optimize product label claims
• lifecycle management
• a global submission strategy
• target submission and approval dates
• special populations and special safety evaluations
• implications of licensing agreements
• regulatory risks
• details on exclusivity
• accelerated development and approval options
• trademark information
• a plan for future interactions with regulatory authorities
• key product-label attributes
• external influencing
• table of advice from regulatory authorities and outstanding commitments

Hence, there is no set way to develop a regulatory strategy. As a result, the Method chosen needs to take into account the company’s goals, over both the short and long term. Most noteworthy there can be trade-offs between speed and cost of development.

Therefore the regulatory method must strike a balance between what the company can afford, therefore what is needed to take the product to market with the identified TPP, and how fast the company can achieve drug development. The regulatory document should be almost a living document that evolves as drug development progresses and more is learned about the product.

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Abbreviation used in pharma regulatory

abbreviation

Abbreviation

An abbreviation is a shortened form of a word or phrase. It consists of a group of letters taken from the word or phrase. For example, the word abbreviation can itself be represented by the abbreviation abbr., abbrv., or abbrev.

Abbreviation used in pharma regulatory

Abbreviation Full name
M Micron
MCA Medicines Control Agency, now MHRA
ach Air changes per hour
ACOL Acceptable Carry-Over Limit
ADI Acceptable Daily Intake
ADR European Agreement on the Transport of Dangerous Goods by Road
AHU Air Handling Unit
AIM Active Ingredient Manufacturer
ANDA Abbreviated New Drug Application ( USA)
AP Applicant’s Part (of EDMF)
API(s) Active Pharmaceutical Ingredient(s)
APIC Active Pharmaceutical Ingredients Committee of CEFIC (website: http://apic.cefic.org)
APM Asset Performance Management
APR Annual Product Review
AR Annual Report
ASMF Active Substances Master File (Europe)
BACPAC Bulk Actives Post Approval Changes
Bioavailability A measure of extent of drug absorption in the body
Bioequivalence A study to demonstrate the equivalence of 2 medicines
BLA Biologies Licence Application (FDA)
BP British Pharmacopoeia
BPC Bulk Pharmaceutical Chemical ( USA ) – includes Actives and non-Active
BPE Bulk Pharmaceutical Excipients
BMR Batch Manufacturing Record
B Batch
COA Certificate of Analysis
CBE Changes Being Effected (FDA)
CBER Centre for Biologies Evaluation and Research (FDA)
CCP Critical Control Point
CDER Centre for Drug Evaluation and Research
CEP See C of S
CEFIC European Federation of Chemical Industries – Conseil European des Federations de l’Industrie Chimique
CFRs US Code of Federal Regulations
CFU Colony Forming Unit
cGMP current Good Manufacturing Practices
CHMP Committee of Human Medicinal Products – part of EMEA
CIP Clean in Place
CMC Chemistry, Manufacturing and Control section of Registration Dossier
COMAH Control of Major Accident Hazard Regulations
COP Clean Out of Place
COSHH Control of Substances Hazardous to Health
CPMP Committee of Proprietary Medicinal Products now CHMP – part of EMEA
CPG Compliance Policy Guide (FDA)
CPP Critical Process Parameter
CQA Critical Quality Attributes
CT Clinical Trial
CTD Common Technical Document – Dossier for Products – ICH format
CVM Centre for Veterinary Medicines (FDA)
CVMP Committee for Veterinary Medicinal Products – part of EMEA
DI De-ionised (Purified) water
DMF Drug Master File
DOP Dispersed Oil Particulates
DQ Design Qualification
DR Deviation Report
DS Drug Substance
DSM Drug Substance Manufacturer
EAM Enterprise Asset Management
EC European Commission
ECM Enterprise Calibration Management
EDMF European Drug Master File
EDQM European Directive for the Quality of Medicines
EDR Enhanced Design Review
EFD Engineering Flow Diagram
EFPIA European Federation of Pharmaceutical Industries Association
EINECS European Inventory of Existing Commercial Chemical Substances
EIR Establishment Inspection Report (FDA)
ELD Engineering Line Diagram
ELINS European List of Notified (New) Chemical Substances
EMEA European Medicines Agency
ER&S Electronic Records and Signatures
ERA Environmental Protection Agency
ERP Enterprise Resource Planning
EU Endotoxin Unit or European Union
Eudralex Rules Governing Medicinal Products in the European Union (European Drug Regulation Lexicon)
EWG Expert Working Group
FMEA Failure Modes and Effects Analysis
FD and C Act US Federal Food Drug and Cosmetics Act
FD-483 Official FDA form for inspection observations
FDA Food and Drug Administration
FIA Freedom of Information Act ( USA)
FIFO First In First Out
FS Functional Specification, Federal Standard (USA) engineering standards typically
g Gram
GAMP Good Automation Manufacturing Practices
GC Gas Chromatography
GCLP Good Control Laboratories Practices
GCP Good Clinical Practice
GEP Good Engineering Practices
GHS (CPL) Globally Harmonised System of Classification and Labelling of Chemicals (UN)
GLP Good Laboratory Practice (applies to toxicology laboratories/studies)
GMP Good Manufacturing Practice
GxP Good “x” Practices = GMP, GAMP, GCLP, etc.
HACCP Hazard Analysis, Critical Control Point
HAZOP Hazard and Operating Studies
M Micron
HEPA High Efficiency Particulate Air filter
HPLC High Pressure Liquid Chromatography
HR Human Resources
HTM Health Technical Memorandum
HVAC Heating Ventilation and Air Conditioning
IATA International Air Transport Association
ICAO International Civil Aviation Organisation (UN)
ICH International Conference on Harmonisation ( USA , EU, Japan)
IMDG International Maritime Dangerous Goods Code
IMO International Maritime Organisation
IMP(s) Investigational Medicinal Product(s)
IND Investigational New Drug ( USA)
IPC In Process Control
IPPC Integrated Pollution Prevention and Control
IPEC International Pharmaceutical Excipients Council
IQ Installation Qualification
IQA Institute of Quality Assurance (UK) (www.iqa.org)
ISO International Standards Organisation
ISPE International Society of Pharmaceutical Engineers (ww.ispe.org)
IT Information Technology
JP Japanese Pharmacopoeia
Kg Kilogram
LAF Laminar air flow
LD50 Lethal Dose where 50% of the animal population die
LOD Limit of Detection
LOQ Limit of Quantification
MA Manufacturing Authorisation
MAA Marketing Authorisation Application (Europe)
MACOL Maximum Acceptable Carry Over Level
MDD Maximum Daily Dose
Mfg Manufacturing
MHRA Medicines and Healthcare products Regulatory Agency (UK)
Mkg Marketing
ML Manufacturer’s Licence – UK Licence for Medicines Manufacturing sites
MRA Mutual Recognition Agreement
MRO Maintenance Repair and Operations
MRP Manufacturing Resource Planning
MSDS Material Safety Data Sheets
N/A Not Applicable
NASA National Aeronautic and Space Agency ( U.S.A. )
NC Non-clinical (phase, studies)
NCE New Chemical Entity
NDA New Drug Application ( USA)
NF National Formulary ( USA)
NLT or > Not Less Than
NMT or < Not More Than
NOAEL No Observable Adverse Effect Level
NOEL No Observable Effect Level
NONS Notification of New Substances Regulations 1993 (EU)
OE Office of Enforcement, FDA
OEL Occupational Exposure Level
OHH Occupational Health and Hygiene
OOS Out of Specification
OQ Operational Qualification
ORA Office of Regulatory Affairs, FDA
ORO Office of Regional Operations, FDA
OSHA Occupational Safety and Health Administration ( USA )
OTC Over the counter medicine
P&ID Piping and Instrument Drawing
PAD Pharmacological Active Dose
PAI Pre Approval Inspection
PAR Proven Acceptable Range
PAS Prior Approval Supplement (FDA)
PAT Process Analytical Technology
PDA Parenteral Drug Association ( USA)
PDE Permitted Daily Exposure
PFD Process Flow Diagram/Drawing
Ph. Eur. European Pharmacopoeia
PHA (HazAn) Process Hazard Analysis
PhARMA Pharmaceutical Association of Research-based Manufacturers (PMA, USA )
Pharmacokinetics The study of the rate of adsorption of medicines in the body
P-I, P-II, P-III Phase I, Phase II, Phase III (in Clinical Trials)
PIC/S Pharmaceutical Inspection Convention/Cooperation Scheme
PL Product Licence – UK Marketing Authorisation (Dossier)
PLC Programme Logic Controller
PMA Pharmaceutical Manufacturers Association
POM Prescription Only Medicine
ppb Parts per Billion
PPE Personal Protective Equipment
ppm Parts per Million
PPM Planned Preventative Maintenance
PPQ Process Performance Qualification
PQ Performance Qualification or Process Qualification
PQG Pharmaceutical Quality Group (www.pqg.org)
PQR Product Quality Review
PS or P/S Particle Size
PTFE Polytetrafluroethylene
PV Process Validation
QA Quality Assurance
QC Quality Control
QOS Quality Overall Summary (of CTD)
QP Qualified Person
QSIT Quality Systems Inspection Technique
QU Quality Unit
QWP Quality Working Party
R&D Research and Development
RD Registration Dossier
RH Relative Humidity
RO Reverse Osmosis
RM Raw Material
RP Restricted Part (of EDMF)
RSM Registered Starting Material
SHE (or HSE) Safety, Health and Environment
SM Starting Material
SMF Site Master File
SOP Standards Operating Procedure
SPC Summary of Product Characteristics
SPC Statistical Process Control
SUPAC Scale-up, Post Approval Changes (FDA)
TAVC Total Aerobic Viable Count
TDI Tolerable Daily Intake
TGA Therapeutic Goods Agency ( Australia)
TLC Thin Layer Chromatography
TNTC Too Numerous To Count
TOC Total Organic Carbon
TSCA Toxic Substances Control Act 1976 ( USA )
TSE Transmissible Spongiform Encephalopathies (BSE)
TT Technology Transfer
TTR Technology Transfer Reports
TVC Total Viable Counts
U Units
ULPA Ultra Low Particulate Air Filter
URS User Requirement Specification
USP United States Pharmacopoeia
UV Ultra Violet
VMP Validation Master Plan
VOC Volatile Organic Compound
VSR Validation Summary Report
WFI Water for Injection
WHO World Health Organisation

 
these were the popular abbreviation used in pharma industry and these abbreviation are used when creating regulatory documents
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Regulatory Affairs Explained

Regulatory

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. RA also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of RA professionals.

The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. RA plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. The drug development process is a lengthy, complex and extremely costly albeit necessary process.

Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug. Throughout the development stages, pharmaceutical companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans. In this highly regulated environment, regulatory affairs plays a critical role not only as the interface with health agencies and as a link between different departments in the company but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug.

Regulatory professionals keep working with the authorities and different departments within the company in order to meet regulatory commitments with the health authorities. Regulatory Affairs also ensures the maintenance of the marketing licence and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage etc..

Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.

Qualities of a good RA professional

  • Authoritative
  • Team Player
  • Decisive
  • resourceful
  • Good Communication Skill
  • Analytical Skill- Ability to evaluate the strengths and weakness of the technical and legal options open to a company.
  • Good Informational Technology skills
  • Negotiating Skills
  • Able to reapply scientific and regulatory principles
  • Ability to work with other disciplines
  • Flexible- Always willing to learn.

Responsibilities of Regulatory Affairs Department

  • Keep in touch with international legislation, guidelines and customer practices
  • Keep up to the date with a company’s product range
  • Ensure that a company’s products comply with the current regulations.
  • The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.
  • Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects.
  • Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization.
  • Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents.
  • Monitor the progress of all registration submission.
  • Maintain approved applications and the record of registration fees paid against submission of DMF’s and other documents.
  • Respond to queries as they arise, and ensure that registration/ approvalare granted without delay.
  • Impart training to R&D, Pilot plant, ADl and RA. Team members on current regulatory requirements.
  • Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
  • Manage review audit reports and compliance, regulatory and customer inspections.
  • Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.
  • Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product.

Major Regulatory Authorities

  1. India-Central Drugs Standard Control Organization drug controller general of India (DCGI)
  2. US-Food and Drug Administration (US FDA)
  3. UK-Medicines and Health care products regulatory Agency (MHRA)
  4. Australia-Therapeutic Goods Administration (TGA)
  5. Japan-Japanese Ministry of health, Labour and Welfare (MHLW)
  6. Canada-Health Canada
  7. Brazil-Agency Nacional degradation Vigilancia Sanitaria (ANVISA)
  8. South Africa-Medicines Contol Council (MCC)
  9. Europe-European Directorate for Quality of Medicines (EDQM),European Medicines Evaluation agencies (EMEA)
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Our Services

Services
Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission.
Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations.

Medical and Clinical Consulting

Consulting on the Complete Product Development Program (all phases)
Reviewing and Assessing Clinical Protocols
Reviewing Safety and Efficacy Related Issues During Product Development
Adjudicating Clinical Data
Worldwide Drug Safety and Pharmacovigilance Services

Clinical Trial Safety Services
Post-Marketing Surveillance Services
Pharmacovigilance Consulting Services
EudraVigilance Reporting
Regulatory Support of New Chemical Entities

Global Regulatory Strategies
Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
CMC (Chemistry, Manufacturing, Control)
Medical Writing
Labeling
Translations of Technical Documents
Coordination of Regulatory Certificates
In-licensing of Products for Marketing in the Emerging Markets

Assessment of Local Medical Need
Assessment of the Local Business Opportunity
Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
Potential in-licensing of the Product
Serve as the Local Marketing Authorization Holder
Sales, Marketing, and Distribution Performed by a Local Distributor
Postmarketing Regulatory Maintenance
Regulatory Maintenance of Marketed Products

Life Cycle Management of Recently Marketed Products
Regulatory Maintenance of Older Products
CMC (Chemistry, Manufacturing, Control)
Post-Marketing Drug Safety & Pharmacovigilance
Labeling Updates and Harmonization of Labels
Product Transfers
Product Acquisitions (regulatory due diligence)
Company Mergers
Company Acquisitions (regulatory due diligence)
Regional Marketing Deals (co-promotion, co-marketing)
Coordination of Regulatory Certificates
Special Projects
Educational Activities

Training of personnel in pharmaceutical companies
Training of regulatory agency personnel from the emerging markets
Organizing meetings with drug development topics
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PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)

actd

ACTD INTRODUCTION

ACTD (ASEAN Common Technical Dossier) is a dossier for marketing authorization of Pharmaceutical / Biologicals / biotechnical products in ASEAN region. ACTD is essentially divided into 4 parts. Each part provides information under specific head.

Part I of ACTD provides admin and brief product information

Part II of ACTD provides Quality related information on the drug substance and drug product.Out of all the parts, the part II is most important. In this one section is completely devoted to QOS and another section is devoted to detailed data on drug substance and drug product. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients. It consists of 4 distinct parts named e.g. as Part1, Part 2, Part 3 and Part 4.

Part III of ACTD provides nonclinical profile of the product and Part IV of ACTD provides clinical profile of the product For generic products the most important part is Part II. The part III is virtually not required. The part IV is required to the extent applicable to BE studies.


Table 1: Preparation & Compilation of Drug Substance part in ACTD (2-3,4)


 

The drug substance part is allotted code S and the subsections are listed as S1, S2 and so on. Each subsection is further divided as required

 

Provide the analytical procedure used for testing the drug substance should be provided in sufficient detail to enable reproducible testing by another laboratory.As far as possible the substance shall be tested as per Compendial methods. However, if the method used is out of compendia the sufficient information on the same shall be provided from the supplier.

version Content
S 1.1 Provide International non–proprietary name (INN),Compendial name ,CAS No ,Chemical name(s)
S 1.2 Provide Structural formula of drug substance
S 1.3 Provide Physico-chemical description, solubility, refractive index , melting point, polymorphism, particle size, chirality of the drug substance
S 2.1 Provide manufacturer’s Name and full addresses including the city and country of the manufacturer of active ingredients.
Also provide Name and address of Contract manufacturers/contract analytical laboratories, if any
S 2.2 Describe the manufacturing process and process in sufficient details
S 2.3 Describe specification and test methods for raw materials, starting materials, solvents, reagents, catalysts as used in manufacturing
S 2.4 Narrate the critical steps along with their standard values and experimental findings.Narrate the critical steps along with their standard values and experimental findings.
S 2.5 Provide Process validation Plan, experimental data and final conclusion. The analytical methods used for validations may be cross referenced / provided suitably
S 2.6 Provide process development details
S 3.1 Describe Confirmation of structure based on synthetic route and spectral studies. Also include Information on isomerism and polymorphism if applicable.
S 3.2 Provide information on general impurities and related products
S 4.1 Provide detailed specification, tests and acceptance criteria for the drug substance. Compendia specifications are adequate. Indicate clearly whether the drug substance is purchased based on specification with a certificate of analysis, or tested by applicant. Indicate if any additional specification are applied
S 4.2 Provide the analytical procedure used for testing the drug substance should be provided in sufficient detail to enable reproducible testing by another laboratory.
As far as possible the substance shall be tested as per Compendial methods. However, if the method used is out of compendia the sufficient information on the same shall be provided from the supplier.
S 4.3 Provide experimental data for the validation of analytical procedure used for testing the drug substance. Cover validation parameters such as specificity, precision, repeatability, reproducibility, accuracy, linearity, range, limit of quantitation, limit of detection, robustness and system suitability.
S 4.4 Provide COA of three batches
S 4.5 Provide justification of specifications if the same are different to those detailed in Pharmacopoeia.
S 5 Provide the source and control No of Primary and secondary Reference standard used for analysis
S 6 Describe the identity of materials of construction of, dimensions, drawings, functional characteristics, test methods for primary packaging materials.
Provide only a brief description for non-functional secondary packaging components. Discuss where necessary sorption ,leachability and safety
Discuss the suitability functional secondary packaging components so as to cover their choice, physical characteristics, compatibility with primary packaging materials
S 7 Provide summary of stability studies conducted, protocols used and the results and conclusions.
Describe the forced degradation studies conducted under stress conditions such as high temperature, humidity and hydrogen ion concentrations. ,
Provide conclusions with respect to storage conditions and retest date or shelf-life, as appropriate.
Detail Post-approval Stability Protocol and Stability Commitment
Provide Results of the stability studies in tabular/graphical.
Provide Information on the analytical procedures used and their technical validity Provide this information from Manufacturer or from your own studies carried on the material.

Table 2: PREPARATION & COMPILATION OF DRUG PRODUCT PART IN ACTD (3-4,5)


 

The drug product part is allotted code P and the subsections are listed as P1, P2 and so on. Each subsection is further divided as required.

 

Provide information and data on the development of the dosage form under following heads:The composition developmentProcess developmentAnalytical method developmentThe container closure system developmentAssignment of final specification, microbiological attributes and usagesAssignment of stability and retest period.

The compatibility of the drug product or reconstitution diluents(s) or dosage devices, e.g. precipitation of drug substance in solution, sorption on injection vessels and stability should be addressed to provide appropriate and supportive information for the labeling Literature data are acceptableProvide the batch formula with name and quantities of all ingredients (active and otherwise) including substance(s) which are removed in the course of manufacture should be included:State the actual quantities (g, Kg, Liters) etc. of all ingredient State the reason for including the overage State the State total number of dosage unit per batch.Provide description of all stages involved in the manufacturing of the productProvide analytical procedure used for the testing of critical Excipients i.e. substances which affect stability and bioavailability of finished product (e.g. preservative, buffer components, dissolution enhancer, and stabilizer) should be provided.

version Content
P 1 Provide description of the drug product and its composition.
Check that the composition includes list of all components of the dosage form, and their dosage on a per-unit basis (including overages, if any). Further indicate function of each component and its quality standards
Specify the composition of any diluents required for reconstitution before use.
Also indicate the Type of container and closure used for the dosage form
P 2.1 Provide information and data on the development of the dosage form under following heads:

  • The composition development
  • Process development
  • Analytical method development
  • The container closure system development
  • Assignment of final specification, microbiological attributes and usages
  • Assignment of stability and retest period.
P 2.2.1 Provide specifications for Active ingredients.
Discuss special characteristics such Water content, solubility, particle size distribution, polymorphism and chirality if applicable
P 2.2.2 Provide the specifications for Excipients.
Discuss special characteristics such Water content, solubility, particle size distribution if applicable
P 2.3.1 Discuss the development of the final product with special reference to Results from comparative in vitro studies (e.g. dissolution) or comparative in vivo studies (e.g., bioequivalence)
P 2.3.2 Discuss if overages are included in the dosage form.
P 2.3.3 Discuss the physiochemical and biological properties of dosage form
P 2.4 Discuss the development of final manufacturing process.
Provide details on the pivotal batches and validation of three initial batches.
P 2.5 Discuss the selection of the container closure system used for packaging, storage and shipping. The discussion shall cover choice of materials, protection from moisture and light, compatibility, accuracy of delivery
P 2.6 If appropriate discuss microbiological attributes of the dosage form.
If microbial studies are not performed discuss the rationale for the same. Discuss the selection and effectiveness of preservatives systems used.
Address the integrity of the container closure system to prevent microbial contamination in case of sterile products
P 2.7 The compatibility of the drug product or reconstitution diluents(s) or dosage devices, e.g. precipitation of drug substance in solution, sorption on injection vessels and stability should be addressed to provide appropriate and supportive information for the labeling.Literature data are acceptable
P 3.1 Provide the batch formula with name and quantities of all ingredients (active and otherwise) including substance(s) which are removed in the course of manufacture should be included:
State the actual quantities (g, Kg, Liters) etc. of all ingredient.
State the reason for including the overage State the State total number of dosage unit per batch.
Provide description of all stages involved in the manufacturing of the product
P 3.2 Provide flow diagram giving the steps of the process and showing where materials enter the process.
Identify and narrate the critical steps and points at which process controls, intermediate tests or final product controls are conducted.
Describe the manufacturing process in sufficient details to cover the essential point of each stage of manufacture.
For sterile product describe preparation and sterilization of components in detail.
P 3.3 Provide Tests, acceptance criteria and test results for critical steps.
Provide information on the quality and control of intermediates isolated during the process
P 3.4 Provide the protocol and results of validation studies
P 4.1 The specification for the Excipients should be provided.
P 4.2 Provide analytical procedure used for the testing of critical Excipients i.e. substances which affect stability and bioavailability of finished product (e.g. preservative, buffer components, dissolution enhancer, and stabilizer) should be provided.
P 4.3. Provide list of Excipients from human or animal origin separately, if any. (Provide information of sources ,specifications, description and safety data of Gelatin, enzyme, or any such materials )
P 4.4 Provide full details of manufacture, characterization and controls, with cross references to supporting safety data (nonclinical or clinical) for Excipients used for the first time in a drug product or by a new route of administration
P 5 Provide summary of the analytical procedure. Provide validation of methods for impurity profiling and assay
P 5.1 Provide the specifications for the finished product
P 5.2 Provide the analytical procedures used for the testing the finished product should be provided.
P 5.3 Provide protocol and experimental data for the verification of analytical procedures use for the testing the finished product. Provide AMV for non-Compendial methods
P 5.4 Provide Batch analyses results of 3 commercial batches.
P.5.5 Provide information on general impurities and related products
P.5.5 Provide results of characterization and assay of Compendial and non Compendial impurities.
P 5.6 Justification for Compendial products is not necessary.
However, if there is some addition or deletion in Compendial specifications, the same shall be justified.
P 6 Detail the reference standard/working standard used for product analysis. Provide relevant COA
P 7 Describe the container closure systems. Please note that test for identity for polymeric materials is quite essential. The specifications should include description critical dimensions and drawings as appropriate.
For non-functional secondary packaging components provide only a brief description. For functional secondary packaging components, provide additional technical information
P 8 Provide summary and conclusions of stability studies
Provide The post-approval stability protocol and stability commitment, Provide stability data in tabular form
P 9 Provide remarks on Product interchangeability

Additional Guidelines

The designing of ACTD Quality Part is not as easy as it looks. The ASEAN region requires proper information strictly as per the index based on actual experimentation. Data fraud is strongly discouraged.The incomplete, unwanted, falsified information is not entertained for registration. The last but not least the information need to be presented in easily readable format with proper margins, font size and font type.

CONCLUSION

For the marketing authorization of the drug products ACTD the technical documents subdivided 4 parts is essential. The part 2 is a very critical part of the submission. The information on both the drug substance part and the drug product part shall be included in this part as detailed above.

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GMP(Good Manufacturing Practice)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP

All guideline follows a few basic principles:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
  • GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

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Regulatory affairs

Affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals, etc. Government affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Government affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:

• Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance

Healthcare RA

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulation professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

• pharmaceuticals
• medical devices
• in vitro diagnostics
• biologics and biotechnology
• nutritional products
• cosmetics
• veterinary products

The regulatory professional’s roles are the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.

Core competencies

Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor’s degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.

Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.

Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.

Global aspects of regulatory affairs are taken up by organisations such as the Drug Information Association (DIA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Origins

The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead:

• Diphtheria Epidemic led to 1902 Biologics Control Act
• Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
• Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
• Thalidomide led to the 1962 Kefauver Harris Amendments
• Dalkon Shield led to the 1976 Medical Device Amendments
• Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act

In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations

Recent developments

Starting in 1980 the European Union started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation.

Concurrently the EU had been developing the concept of New Approach Directives where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).

The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.
The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the international template.

Future developments

Many in the Medical Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.

Medical Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the Medical requirements, some companies also choose to outsource or outtask Healthcare affairs to external service providers.

Medical Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Regulatory affairs profession

The healthcare affairs profession is still an emergent profession but has four major international professional membership organizations:

• Drug Information Association, DIA
• The medical Affairs Professionals Society, RAPS
• The Organisation for Professionals in Regulatory Affairs, TOPRA
• Association of medical Affairs Professionals, ARAP
• Vietnam medical Affairs Society: VRAS

which offer education and training, professional development, competence certification and codes of ethics.
The Medical professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.

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