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 (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 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.
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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