The Pharmaceutical industry, also colloquially known as the “drug industry,” is necessarily among the most tightly regulated industries in the world. The reason for this degree of regulation is that the health and safety of individuals, even large populations of individuals, can be significantly affected by even the smallest of mistakes within the pharmaceutical manufacturing process.
The FDA regulates the pharmaceutical industry through a series of regulations known as the Current Good Manufacturing Practices (CGMPs) for human pharmaceuticals. The FDA has intentionally drafted the CGMP requirements to be malleable in order to allow pharmaceutical manufacturers to have the flexibility necessary to build quality controls that are able to provide the best protections within a manufacturer’s unique product and processes.
The “C” in CGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. The FDA expects the pharmaceutical industry to use the most current industry standards within the production quality control systems. As far as the FDA is concerned, the quality controls of the testing laboratory performing contract testing are a part of the quality systems of the manufacturer for which such testing is being contracted. Thus, the pharmaceutical industry expects testing laboratories to follow the very latest guidance from the FDA, including interpretation of the guidance through warning letters and other FDA materials.
Unfortunately, the flexibility FDA created in the guidance for the benefit of consumers has also led to differing levels of compliance with CGMPs by contract testing laboratories. As a result, a wide variation exists within compliance to CGMP within the analytical testing laboratory industry. Unfortunately, many of these laboratories fall below a reasonable standard of compliance, leaving pharmaceutical manufacturers to make difficult decisions in choosing the right partner for contract CGMP analytical testing. Most laboratories may not even realize they are not in compliance with CGMP because they do not have a team of quality experts focused on keeping up on the latest quality trends.
Global Pharma Analytics has intentionally created a world-class CGMP quality team. Because quality comes first at GPA, the stringency of our quality system is readily apparent to our clients from the first use of our services, through a client audit, and beyond. For this reason, Global Pharma Analytics has continued to retain a high-level of customer loyalty within the pharmaceutical industry.
If you are part of a pharmaceutical manufacturer in need of a contract CGMP analytical chemistry laboratory, please contact us today to discuss how Global Pharma Analytics can serve you.
To learn more about CGMP, click HERE to visit the FDA website.