February 8, 2021
A common question we face in the cleanroom industry is the difference between GMP and cGMP practices. To cut to the point, the difference between GMP and cGMP is that GMP requires manufacturers to ensure that their products are safe and effective. cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations. Regulations and standards can be tricky, so let's dive a little bit deeper on this topic.
GMP stands for Good Manufacturing Practices which require manufacturers, processors, and packages of drugs, medical devices, certain 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, mix-ups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. These regulations are enforced by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.
GMP regulations address issues such as:
· Record keeping
· Personnel qualifications
· Equipment verifications
· Process validation
· Complaint handling
cGMP stands for Current Good Manufacturing Practices. Manufacturers who follow cGMPs must employ technologies and systems which are up to date that also comply with GMP regulations. cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls. This flexibility allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.
Cost is a notable differentiator. cGMP uses new, innovative technology, which can be more expensive. cGMP goods undergo significantly more testing to ensure proper use of new manufactured goods and that certification is accurate and proven to be effective. cGMP regulations are very specific, using the newest technologies available at the time in production.
Pharmaceutical and biotechnology companies follow cGMPs to ensure their products are consistently produced and controlled according to quality standards. Consumers expect that each batch of manufactured goods meet the quality standards so that they will be safe. For drug manufacturing companies, adhering to these regulations assures their drug products:
Some of the Code of Federal Regulations pharmaceutical and biotechnology companies must follow are:
· 21CFR Part 314: FDA Approval to market a new drug
· 21CFR Part 210: Processing, Packing, or Holding of Drugs
· 21CFR Part 211: Finished Pharmaceuticals
· 21CFR Part 600: Biological Products
These regulations will help prevent contamination and maintain the level of quality of pharmaceutical drugs, medical devices, diagnostic test kits and other biotechnology-related products.
As managing partner, Phelan is responsible for ensuring client satisfaction, shaping the company’s strategic direction, and managing all compliance aspects of the organization.