When manufacturing, handling or selling bio-pharma or medical products, it’s critical for a biotech or pharmaceutical business to operate in a manner that adheres to the government’s Current Good Manufacturing Practice (CGMP) regulatory requirements. Below are some historically important points from the evolutionary timeline of this federally constructed and imposed standard.
- Upton Sinclair’s muckraking novel The Jungle
inspires Congress to pass the Pure Food and Drug Act of 1906—the fundamentals of CGMP derive from this piece of legislation
- After the Messengill sulfanilamide tragedy of the 1930s, the Federal Food, Drug and Cosmetic Act of 1938 requires drug companies to confirm that products are safe for consumers
, bolstering the original law
- Frances Oldham Kelsey of the FDA
withholds thalidomide from the U.S. market, protecting pregnant women’s nervous system from the horrific effects of the ineffective painkiller
- The initial GMP guidelines, requiring that drugs be proven as safe and effective, pass as drug law amendments in 1962
- Subsequent laws of the 1960s and 1970s address issues like data documentation, packaging and labeling and tampering
Drug manufacturing has changed dramatically since the dawn of the 20th century.
These days, CGMP, through the Code of Federal Regulations (CFR) and FDA enforcement, require that pharmaceutical companies utilize and employ the latest technologies and processes and training standards. These generally include, but are not limited to, the following:
- Maintenance, calibration and validation of equipment
- Condition of facilities
- Qualifications and training of employees
- Reliability and reproducibility of processes
- Test method validation
- Handling of complaints
In addition, Biotech and pharmaceutical firms should pay particular attention to section 21 of the CFR. Violations, especially egregious ones, may lead to criminal penalties. Included sections deal with the manufacturing, processing, packing and holding of drugs, the practices required for finished pharmaceuticals, biological products and guidelines for electronic records and signatures.
Elements of these CFR sections can be applied to such bio-pharma sectors as vaccines, prescription pills and medicated creams. Deeper analysis and an understanding of such products and their sector-specific regulatory challenges can provide firms with the knowledge needed to take proactive, risk-reducing steps. Such steps, like purchasing an automated temperature monitoring device and recording service can mean the difference between good manufacturing practices and noncompliant ones.
Next week we’ll continue our survey of CGMP with a good look at vaccines and their applicable CFR guidelines.