The most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render products as “adulterated” in the eyes of the FDA. Failure to comply could lead to disruptive regulatory action against a company.
What Does 21 CFR Part 210 And 211 Contain?
Part 210 outlines minimum Good Manufacturing Practices (GMP) in manufacturing, processing, packing or holding of all drugs or medicated articles under the purview of the FDA, while Part 211 refers specifically to the GMP requirements of finished pharmaceuticals. When applicable regulations conflict, general requirements are superseded by drug-specific GMP requirements.
Regulations in Part 211 cover a litany of subjects, from personnel, facilities and equipment, to production processes, stability testing and labeling, just to name a few. The onus is placed firmly on the manufacturer to prove that they have adhered to all these regulations. This is largely because although much of what is required for GMP compliance is specified, the how is primarily left to the manufacturer to determine. This necessitates the extensive development of validation methods and product-specific procedures.
Self-Mediated Full Compliance
The ability of a manufacturer to create, and perhaps even more importantly, to consistently follow and document procedures that address the requirements in 21 CFR Part 211, will in large part determine whether or not GMP compliance has been met. The more complex and rigorous the procedures become, the more time and resources are required to prove compliance.
Actionable Versus Non-Binding Recommendations
The FDA regularly issues Final and Draft documents that detail the cGMPs for particular products or a subset of those products. Guidance for Industry: Current Good Manufacturing Practice for Medical Gasses, for example, was issued in Draft form in May of 2003.
The difference between legally enforceable GMP requirements and non-binding recommendations lies in the use of the word must and should, respectively. Importantly, non-binding recommendations allow for alternative approaches if they still satisfy otherwise established regulatory requirements.
GMP Compliance Is Complicated
Although it is possible to point to the Code of Federal Regulations in order to find what is technically required for full GMP compliance, the reality is that successful implementation is far more complicated. There exists some ambiguity, whether intended or not, regarding what the FDA expects and will enforce in terms of GMP compliance, and what it merely recommends or desires. This degree of uncertainty makes it vital for knowledgeable and experienced individuals to be involved or consulted in any decision making process dealing with compliance issues.
GxP-CC experts provide businesses with well over 20 to 25 years of international experience in GMP manufacturing solutions in the medical device and pharmaceutical industries. Contact them to discuss your needs in meeting FDA compliance regulations for your products.