What YOUR GMP Certification IS and IS NOT
July 12, 2024
Written By: Brandon Griffin
In an industry where trust is everything, the rise in FDA Warning Letters to companies that either posses a GMP Certification for their facility or that are wholly reliant on their vendors that do, reveals a startling truth: not all that glitters is gold. This new troubling trend of companies receiving warning letters with Certifications touting FDA cGMP compliance on the wall, raises critical concerns about the true value of these certs, the quality not to mention consistency of the audits, and the serious misconceptions surrounding them to downstream brand owners and consumers alike.
It’s important to understand that the FDA (as well as FTC and even USDA) does not officially recognize any GMP Certifications for any domestic US operations, not a single one. Despite this, many brands and companies invest in these certification programs, perhaps believing that they offer a safeguard against regulatory or legal scrutiny, while others are just going with market demand. Many retailers, brink-and-mortar as well as online marketplaces, set their own requirements for some sort of GMP certification, but that again is not a regulatory requirement. From a marketing perspective, it may certainly help to pre-qualify a given vendor who has gone through an independent inspection depending on the degree of that audit, but it itself is not a qualification of said vendor. It is also very important to note that no GMP Certification organizations have the same degree of auditing, and the quality of such audit reports vary greatly. If you are a Brand Owner being told that you don’t need to audit a given company because of them being GMP Certified, think again!
One significant issue is that many major retailers or marketplaces now require GMP certifications from their vendors e.g. Amazon. While this might seem like a positive step towards ensuring product safety and quality, it often leads to a dangerous complacency and compliance gaps. Many brand owners, especially small ones, assume that a GMP certification equates to THEIR full operational compliance being met, overlooking the critical need for their own record keeping and controlled document e.g. SOPs, etc., as well as qualification audits of their vendors. If your manufacturing partner will not permit and audit their facility, this is a big red flag!
Why do companies continue to pay for these certifications if they hold no regulatory weight? The answer lies in perception and market pressures to have something, which is better than nothing, owing to overall deficient and an inconsistent regulatory enforcement by state and/or federal inspectors. While some GMP certification groups are more thorough than others in their audits, none supplant the GMP requirements. GMP Certifications can be seen as a mark of credibility, achieving a higher standard and even transparency, something that can be showcased to customers. However, without strict continual adherence to the actual GMP regulations, these certifications become meaningless, a mere facade of compliance when a real FDA inspection happens, or even sometimes during a client audit as we’ve experienced many times over.
What a GMP Certification is:
– it is a Nice To Haveonly
– it is a representation of a single time point of vendor compliance i.e. at the date/time of the audit only
– it is a representation of the compliance of the vendors’ operations only and their commitment to compliance/quality (depending on the quality of the audit of course)
– it is generally a solid marketing tactic to help differentiate a company and be a demonstration of an investment into the brand or service offerings
– it is often needed for the requirements set forth by select retailers in order for to be onboarded in the stores or online platforms
What a cGMP Certification is not:
– it is not a “Need To Have” (its not a requirement from a regulatory or legal perspective)
– it is not a replacement for your compliance obligations or documentation IF you are a brand owner
– it is not a qualification of your vendor(s) IF you are a brand owner
– it is not something that can exceed the standards set forth by the FDA nor recognized by the FDA for US entities
– it is not transferrable to a brand owner or other entity/facility that was not explicitly audited
– it is not universal, meaning that each organization offering cGMP Certifications or Verifications have their own standards and criteria which vary greatly
Rigorous audits by qualified and experienced auditors with a deep understanding of the applicable operational regulatory requirements are essential to avoid the pitfalls of non-compliance, leading to regulatory actions, recalls or even legal actions. Remember, true compliance is not about possessing a certificate but about consistently adhering to regulatory standards on a daily basis. Knowing the performance of your vendor, for whatever is being outsourced, is a regulatory requirement for Brand Owners, in addition to your own compliance documentation and record keeping – you can’t outsource that. For co-mans, distributors, and traditional manufacturers as well as contract labs, ensure you are holding your internal Quality Unit accountable at all times.