Good Manufacturing Practice (GMP) Regulation
In 2005, you may remember that the U.S ran out the flu vaccine, Fluvirin, which created a panic in the U.S and Europe. The UK manufacturing plant failed to provide approximately half of the United States’ influenza vaccine for 2004-2005 – 48 million doses. The manufacturer was shut down after British regulators suspended the license of this Liverpool, England-based Chiron plant.
Chiron, an American multinational biotech firm, discovered that the plant failed to follow Good Manufacturing Practice (GMP). GMP is a set of regulations put in place to ensure the safety, purity and effectiveness of drugs, medical devices, food and other specific products; it regulates everything in the manufacturing process, including record keeping, equipment validation, and employee qualifications.
Chiron failed to comply with GMP rules in a number of ways. It failed to document the impact of a sterility failure on its product, to use proper storage temperatures for the vaccine, to properly follow procedures for cleaning and maintaining equipment, to correctly review and audit production records for accuracy, and to take corrective action after experiencing alerts of contamination.
Both the FDA and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) cited bacterial contamination in some lots of the Fluvirin vaccine, and found Serratia bacteria in nine of its 100 flu vaccine lots. Because the plant had failed to keep adequate records of each vaccine batch, it could not trace where the problem started and could not determine if the other 91 lots were contaminated. As a result, none of the batches were safe to use, resulting in the loss of half of the flu shots earmarked for the United States and about 10 to 20 percent of the U.K.’s doses.
The U.S. scrambled to acquire enough vaccines to protect against the influenza virus, which kills 36,000 Americans each year. Chiron’s stock plunged, reporting a $22.9 million net loss in the fourth quarter of 2004.
Warding off contamination can be particularly challenging for food manufacturers that offer tours of the plant to visitors as well. If you have ever toured the Yuengling Beer Factory in Tampa, Florida, the Cape Cod Potato Chip Factory in Hyannis, Massachusetts, or the Ben & Jerry’s Ice Cream Factory in Waterbury, Vermont, you know that they all welcome visitors, but they do demand visitors to abide by strict security measures.
For instance, Tulkoff Food Products, Inc. in Baltimore, Maryland, offers tours of its factory, and it does so by maintaining tight restrictions on visitors. The company even posts the following message on its website so visitors know what to expect:
Because Tulkoff follows strict FDA regulations and Good Manufacturing Practices (GMPs), a complete GMP form will be provided to you prior to your tour and will require signatures from each individual in your group before entering our facility. Some restrictions to be aware of include:
- Cameras or recording devices are not allowed in the factory.
- Bags such as purses, knapsacks, luggage, etc. are not allowed in the factory.
- Closed-toe, low-heeled shoes are required.
- Lab coats, eye wear and designated guest hair and beard nets are required (provided).
- Visitors cannot touch food, surfaces or packaging equipment.
- All jewelry and watches must be removed.
- Visitors with nail polish will be required to wear gloves (provided).
- Visitors with open or infected wounds or communicable illnesses are not allowed in the factory.
Technology plays a vital role in shaping the future of business, and visitor management software is finding new opportunities to help more businesses stay compliant, streamline the visitor management process, provide a memorable experience for visitors and keep businesses running smoothly.
A skilled visitor management and access security team is necessary to help business owners and security directors create and operate an optimal strategy to meet each business’s needs, particularly in regards to compliance.
In the end, Chiron was found to have Serratia bacteria in nine of its 100 flu vaccine lots. Because the plant had failed to keep adequate records of each vaccine batch, it was unable run an audit report and trace where the problem started to determine if the other 91 lots were contaminated.
GMP problems often occur simply because the company does not know enough about regulatory requirements, or they misunderstand them and lack the resources to fulfill them; and Chiron is not the only manufacturer to suffer catastrophic consequences for their regulatory failures.
Proactive communication with regulatory agencies is key to manufacturers avoiding GMP violations, and all regulatory requirements that seem unclear should be discussed and evaluated – from production to visitor management, procedures, equipment, materials, record keeping, audits, administrative oversight and training. If this requires enlisting an experienced outside consultant, the cost is minimal when you compare it to the cost of neglecting safety.