Are your GMPs excellent?

Management commitment. Going beyond “just good” manufacturing practices requires years of investment and ongoing commitment by management. A facility that is committed to excellence always has a leader at the top who is truly committed, and who understands (and can explain) their quality practices.
 

Transparency. The T-word is the foundation of excellence. It means that a manufacturer is available for an audit and welcomes visits when it’s running that brand’s product. It means it answers tough questions with the same expediency and honesty as the easy ones. And it willingly shares information that could make them look bad—such as customer complaints and audit reports.
 

Reams of documentation. A manufacturer with Emps meets auditors with an approximate metric ton of thick binders with all the standard operating procedures (SOPs) and documentation sitting right there on the table ready to review.
 

Experienced, independent quality assurance (QA) leaders. When the QA/quality control (QC) departments are led by folks with extensive experience, training, responsibility and independence from the pressures of production, it shows. Big time.
 

Well trained production staff. In an excellent facility, everyone—especially the most inexperienced staff and the janitor—are part of a culture of quality. Staff trained under a culture of excellence understand all the critical details required in their role supporting GMPs. And they explain what they do every day that goes above and beyond—typically beaming with pride. 
 

Redundancy. GMPs require checks and balances. EMPs demand doubling up on these checks. Double document reviews, double signatures and double testing are common practices in facilities with EMPs. It means testing every lot of material, even if skip-lot testing is supported by a clean history. It means having QC staff on the floor overseeing production and taking samples for testing, even if they don’t have to under the law. Redundancies that many may view as unnecessary aren’t when they prevent a potential failure, and they are a key marker of excellence beyond the minimum GMPs.
 

Supplier qualification. Everyone knows how important ingredients are to the finished product. But due to cost, most manufacturers do the minimum, which is often observed as identity testing raw material (often with questionably valid methods—a topic for another article). Others go well beyond. Physically auditing suppliers, testing the entire specification at independent labs for contaminants, and ensuring analysis methods are fit for purpose aren’t common. Now, under the Food Safety Modernization Act (FSMA), supply chain and preventing economically motivated adulteration has become a required critical control point. Supplier qualification procedures serve as an essential litmus test to know whether a manufacturer goes beyond the minimum requirements. 
 

Cleaning validation. Cleaning is one of the most unseen, underrated parts of GMPs; a piece of processing equipment may look clean from the outside, but harbors gunk and pathogens inside the pipes that contaminate product. Good manufacturers trust that their cleaning program is effective, while excellent ones validate the effectiveness of their cleaning. And then they document it all in the process.
 

Critical internal reviews. Excellent manufacturers have a material review committee, and a regular internal audit schedule that they stick to. They’re always investigating potential gaps in their processes, and being honest with themselves, even if they are already meeting FDA requirements.  
 

Continuous improvement. Improvement is one of the lesser discussed, yet essential, parts of quality management systems. Even when a facility has met the mark of excellence, they are always striving for more and to be better. World-class athletes still have the motivation to keep practicing and getting better. The same is true for world-class manufacturers. In an environment that keeps changing, a brand is left behind if it’s not fully committed to improvement.