Current Good Manufacturing Practices (cGMPs) were adopted in 2007. Small companies have been required to comply starting in 2010. GMPs are common sense rules with the priority being consistency during manufacturing, but have a very large technical aspect as well.
cGMPs require manufacturers prepare and follow Master Manufacturing Records (MMR) aka Master Production Records (MPR) or Master Batch Records (MBR) during production. The documentation that needs to be generated when making a batch is a Batch Production Record (BPR). This is a record that verifies a specific batch followed the recipe in the MMR to the letter.
A large number of firms fail to provide the FDA with adequate documentation about how their batches are made, and the FDA penalizes them for it. Steve Mister, president and CEO of the Council for Responsible Nutrition, mentioned that companies don’t understand what they need to do. They are either “burying their heads in the sand” or have no idea what the requirements are asking them to do.
For the most part, there’s a shortage of information about cGMP requirements that are available in terms that laymen can understand.
Though the FDA is quite serious about bringing firms into compliance, their largest criticism has been about bringing action to noncompliant firms. Some perceive the FDA as an agency that cuts these firms breaks if they’re trying to comply, or show an earnest desire to start on the path to compliance. It’s also true that having injunctions issued, court actions made, and seizure of products are time and resource intensive processes.
Dr. Pieter Cohen talks about how if there was an industry-wide set of Standard Operating Procedures, firms would know that in order to put their products for sale, they’d need to establish Specifications and issue Batch Production Records. The absence of a production “checklist” allow for companies to slip under the radar, but if there was a publicized checklist, companies would initially follow cGMP requirements and the rate of citations would fall.
The other issue is that while the Food Safety Modernization Act (FSMA) granted the FDA the power to conduct mandatory recalls, it must indicate that products that are adulterated must pose a serious risk of adverse reaction or death. The industry is fine with the FDA being granted more abilities to stop these noncompliant firms instead of re-inspecting them and issuing Warning Letters ad nauseam.
Coming into compliance can be costly and the requirements can be difficult to navigate if you’re unfamiliar with GMPs. While there is no industry-wide set of Standard Operating Procedures, InstantGMP provides a set that does help companies to meet cGMP requirements. InstantGMP™ MES was developed by pharmaceutical industry veterans to help manufacturers of Dietary Supplements, CBD, and Medical Marijuana come into compliance with GMPs through the use of Electronic Batch Records and is an invaluable solution when needing to pass an audit or inspection by the FDA. These solutions are cost-effective for every sized firm as compared to other software or consultants. We invite you to sign up for a personalized demo where we’ll show you how InstantGMP™ MES can integrate with your current process.