Exploring GMP Regulations
The serious nature of the Pharmaceutical industry means that sticking to regulations and guidelines is vital to ensure patient safety; one such guideline is Good Manufacturing Process (GMP), adopted by over 100 countries into national medicines laws. GMP is deemed so necessary in fact, that the United States Food and Drug Agency (FDA) boldly claim it “affects every American”. But what exactly are these regulations, and why do they matter?
According to the World Health Organisation (WHO), GMP is the “aspect of quality assurance that ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification”. The guidelines cover everything in production from the starting materials, equipment and premises, to the training and personal hygiene of staff.
Through implementing GMP, consumers remain safe, manufacturers are protected, and waste and losses cut down; this is because several risks associated with the manufacturing of drugs - from cross-contamination through to mix-ups of medications – should be minimised when the guidelines are adhered to.
But what does this mean for microbiology labs? To sustain compliance, having a Quality team of skilled individuals focused on improving current procedures is critical, so any issues can be identified and corrected sooner rather than later. Surprise audits help provide an accurate insight into the facility and identify real causes of non-compliance. Additionally, through a focus on training staff, systems can continually be improved.
All essential processes that could affect quality must be documented in detail, and there must be systems to evidence the correct procedures have been consistently followed at each stage of the manufacturing process, for every product made. Bodies such as the FDA or MHRA (Medicines and Healthcare Products Regulatory Agency) conduct regular inspections to make sure that manufacturers are compliant; if not, consequences could include temporary suspension of manufacturing license, or in some cases, manufacturing license removal.
The challenge with maintaining compliance in microbiology labs is that it is often easier said than done. With many still using legacy manual systems, maintaining data integrity is increasingly difficult. Despite it being of vital importance, some reports suggest the number of warning letters and statements of non-compliance with GMP citing data integrity alone has tripled since 2013. The ever-evolving nature of the Pharma industry makes it difficult for some to keep up with regulations – a 2019 survey suggested 28% Quality Managers consider new regulations and guidance a top obstacle – all whilst financial restrictions combined with pressure from executive leadership mean Quality departments are having to defend their performance in some companies.
If you think this sounds tough– you would be correct. The good news is, however, that there are now easy-to-use, robust systems which can transform your processes and enable you to stay ahead of future regulatory compliance. One such system is Microgenetics SmartControl – intuitive, risk-reducing environmental monitoring software to modernise your microbiology lab. Designed to comply with GMP Annex 11, SmartControl reduces the need for manual data entry and allows MHRA data integrity guidance to be met, whilst providing powerful and rapid data analysis.