What are CGMP regulations?
Current Good Manufacturing Practices (CGMP) regulations are guidelines which are set by the Food and Drug Administration (FDA), United States’ food, drug and cosmetic product safety governing body. CGMPs provide guidelines to develop systems which ensure that manufacturing facilities and processes are properly designed, monitored and controlled.
An industry that operates according to CGMP regulations offers the market products whose quality, identity, purity, and strength has been tested and confirmed according to controlled manufacturing processes.
Part of CGMP for industries includes establishment of robust systems for quality control and management, using raw materials of proven quality, setting up strong operating procedures, identifying how quality deviations can be tested for products and maintaining consistent testing environments. Properly used, this scheme can be successful in curbing incidents of deviations, mix-ups, failures, contamination and other errors.
What is GMP and why is it so important?
Good Manufacturing Practices (GMPs) are systems created and mandated by the government to regulate production, verification and validation of drugs, food and/or medical devices, ensuring that finished products are effective and safe for market distribution.
It’s important to have GMPs because they are guidelines which are enacted to ensure food, drugs, cosmetics, medical devices and related products have no harmful substances. These regulations, enforced by the FDA, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.
GMPs were first enacted in 1963 by the US Congress following the near-sale of thalidomide in the US, after it had resulted in over 10,000 birth defects and infant deformities in Europe.
Today, GMPs are more commonly known as CGMPs, and have been established flexibly to permit every manufacturer to use their discretion in implementing the best controls for their own organization. This flexibility also allows manufacturers to make use of the latest and most innovative technologies to result in products of better/higher quality.
The ‘current’ addition is also used to imply that the FDA expects companies to continuously stay up-to-date with regulations as they are altered to suit changing market and consumer needs. The reason for this is that systems, machines or equipment that were in use, say a few years ago, are not as efficient/effective today, and are hence inadequate in ensuring maximum consumer protection.
Purpose of enacting CGMPs
The average consumer cannot, either by sight, smell or touch, detect whether food, drug or cosmetic products are safe and/or effective. One part of determining this is testing products at various stages of production, but this alone cannot sufficiently ensure quality.
This is because testing is carried out on a rather small batch of products (such as 100 devices from a production line containing one million devices). This way, majority of the products can be sold on the market to maximize profit for the manufacturer, rather than sacrificing them to test procedures.
As such, it is important to have guidelines/regulations governing every step, process, facility or equipment that will be used in the design and manufacture of consumer products. Facilities must be maintained in good condition, good clinical practice should be followed, employees should be properly trained and qualified, validation and verification of equipment should be done to maintain accurate, verified and calibrated measurements and processes should be consistent and reproducible.
These are the main areas covered by CGMP regulations. By complying with the standards established in the regulations, a company has the best chance of always manufacturing products that are effective, efficient and safe for consumer use.
How does CGMP differ from other quality approaches?
There are many quality assurance/control practices. CGMP distinguishes itself since it is mandatory for manufactures of products covered in the Food, Drug and Cosmetic Act. Others, such as ISO quality certification are not mandatory, which means manufacturers are encouraged, but not required to comply with them.
However, many of the aspects covered in the various quality standards are the same, differing only slightly in allowable thresholds. CGMPs include all guidelines relating to process validation, comprehensive corrective and prevent action (CAPAs), vendor qualification, good laboratory practice as well as design and managment reviews.
Failure to comply with CGMPS may attract immediate sanctions for an industry, whereas the same cannot be said of other QC standards like ISO.
Introduction to CGMP compliance
There are many aspects on compliance with Good clinical practice, and CGMPs as required by the FDA. Usually, the FDA conducts an inspection of a manufacturer’s facilities and processes, issuing warning letters and reports detailing areas of non-compliance. Subsequently, these areas highlighted must be corrected within a suitable timeframe, or a company’s products will not be approved for sale into the American market.
The following is the full list of CGMP regulations, detailing coverage of each part.
Part 1: Improving Documentation of GMP Procedures
Part 2: Better Compliance through Master Manufacturing Records
Part 3: Improving Batch Production Records
Part 4: Specifications That Improve Compliance
Part 5: Improving Quality through In-Process Control
Part 6: Documenting Deviations for Improved Compliance
Part 7: Supplier and Vendor Qualification
Part 8: Complaints and Recalls
Part 9: Packaging and Labeling
Part 10: Equipment for Dietary Supplement Manufacturing
Part 11: Facility Design for Dietary Supplement Manufacturing
Part 12: Facility Areas for Dietary Supplement Manufacturing
Part 13: Testing in Dietary Supplement Manufacturing
Part 14: Training Documentation
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