The golden trio of quality: GMP, GCP, and GLP - the pathway to success and compliance09 May, 20234 minutes
Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practic...
Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) are the lifeblood of life science operations. These three guiding principles aren't just industry jargon; they're the foundation for ensuring that products are consistently safe, effective, and high-quality.
These guidelines are critical to the success of any life science organisation. In fact, according to McKinsey, companies that apply smart quality principles to their quality assurance approach can quickly see returns that go beyond their investments in new systems. The perks? A noticeable boost to profits, a 30% faster time to market, and a reliable uptick in manufacturing and supply chain dependability – all music to the ears of board-level folks and product sponsors.
By understanding and adhering to these principles, organisations will enhance their reputation, and foster lasting relationships with key stakeholders, all while navigating the complex world of life sciences regulation.
GMP: The Backbone of Quality and Safety
GMP is the gold standard when it comes to ensuring the quality and safety of pharmaceuticals, medical devices, and biotechnology products. These regulations provide guidance on the manufacturing, processing, packaging, and storage of drugs, ensuring that they meet high standards of quality, safety, and efficacy.
Why is GMP so crucial for life science firms?
Well, the answer is simple: non-compliance with GMP can lead to severe consequences such as product recalls, regulatory sanctions, and even criminal charges.
However, each company develops its own procedures for implementing these practices. As a result, FDA inspectors may cite drug companies for violating current good manufacturing practices due to process complexity, inadequate training, or poorly executed paperwork. In some cases, violations may even appear as deliberate attempts to deceive the inspectors.
In 2008, Olay faced a GMP debacle involving unsanitary conditions at a manufacturing plant in Puerto Rico that could have contaminated their over-the-counter drug products. Olay’s own investigation concluded that poor cleaning and sanitisation practices led to the contamination, as technicians did not disassemble the filler for cleaning. However, the FDA weren’t satisfied with this and citing the company's lack of investigation into the ineffectiveness of its cleaning verification step and the adequacy of its monitoring program.
Olay argued that the product's preservative system killed off the low-level transient contamination. The FDA found this argument highly objectionable, stating that the purpose of preservatives is not to kill microorganisms due to poor manufacturing practices, but rather to prevent their growth in products manufactured in compliance with good manufacturing practices.
So, to put it simply, GMP is absolutely vital in the life sciences world, keeping product quality and safety in check, and shielding companies from the serious fallout that can come from non-compliance.
GCP: Upholding Ethical Standards in Clinical Trials
GCP (Good Clinical Practice) is a set of guidelines for conducting clinical trials on human subjects. These guidelines ensure that clinical trials are designed, conducted, recorded, and reported ethically and in compliance with regulatory requirements. GCP not only ensures the rights, safety, and well-being of trial participants but also guarantees the credibility of clinical data.
Life science firms must prioritise GCP to maintain ethical standards and regulatory compliance. Pfizer and Valneva recently saw the repercussions of not prioritising GCP with their phase 3 Lyme disease vaccine clinical trial when they had to pull 50% of participants. The trial initially aimed to enrol around 18,000 healthy individuals living in Lyme disease-endemic areas and leading lifestyles that put them at increased risk of being bitten by ticks.
However, after discovering GCP violations at certain clinical trial sites managed by a third-party operator, Pfizer, as the study sponsor, decided to discontinue participation for approximately half of the total recruited participants in the trial. Following the announcement of GCP violations, Valneva's share price dropped almost 9%.
This incident underscores the critical role of QA professionals in ensuring GCP compliance throughout the entire clinical trial process. It not only protects trial participants but also keeps organisations on the right side of regulators and stakeholders – a win-win situation for everyone involved.
GLP: Trustworthy Data and Reproducible Results
GLP (Good Laboratory Practice) is a set of principles that guide the conduct of non-clinical health and environmental safety studies. GLP principles ensure that data generated from these studies are reliable, reproducible, and of high quality.
Life science firms must adopt GLP to ensure the accuracy and reliability of their research data. This is crucial for regulatory approval, as well as for building trust with partners, investors, and customers.
A prime example of the consequences of not adhering to GLP can be seen in the case of Valley Biosystems, a West Sacramento, CA-based firm. The FDA found numerous GLP violations at Valley Biosystems during an inspection in late August to early October 2021. The seven-page warning letter cited the firm for five GLP violations, which included inadequate staff training, lack of adherence to their own animal welfare protocol, missing raw data records, insufficient documentation for the study director's adherence to GLP, and inadequate reporting of nonclinical laboratory results. One specific example of GLP noncompliance involved missing anaesthesia records for 12 of the 48 animals that underwent surgery.
So, the takeaway here is that GLP compliance isn't just a nice-to-have; it's an essential part of the life sciences puzzle, ensuring research data is accurate, trustworthy, and ultimately, keeping you in good standing with regulators, partners, and customers.
Ensuring that GMP, GCP, and GLP are all upheld is vital for giving an organisation the best chance of success. It reduces the risk of product recalls which can be costly, damaging to a company's reputation, and pose significant risks to public health. It also boosts operational efficiency by identifying inefficiencies, reducing waste, and minimising errors. As a result, organisations can optimise resources, save costs, and increase overall productivity.
In conclusion, GMP, GCP, and GLP are more than just a set of regulations; they are the golden trio of life science operations. Upholding these principles is crucial for ensuring product quality, safety, and regulatory compliance. Mastering these guidelines and prioritising GMP, GCP, and GLP compliance is essential for safeguarding an organisation's reputation, maintaining stakeholder trust, and ensuring market access.
We understand the importance of hiring top talent who can expertly navigate the golden trio of quality. Our extensive network of highly skilled QA professionals, paired with our deep understanding of the life science sector, enables us to match your organisation with the best candidates for your unique needs.
If you're looking to strengthen your quality assurance team and reinforce your commitment to GMP, GCP, and GLP compliance, we're here to help. Reach out to us today to discuss your hiring needs and learn how our recruitment expertise can support your organisation's plans.