GMP Quality Standards Done Right

GMP Quality Standards Done Right

The United States is home to many pharmaceutical laboratories and other research and development sites that work with radioactive or otherwise dangerous elements. Therefore, good manufacturing process standards, or GMP standards, are often enforced at such work sites. Many American labs associated with the pharmaceutical industry, for example, will make use of GMP storage practices, not to mention GMP quality assurance and GMP synthesis. Isotope labeling, meanwhile, may be done at such a laboratory or clinic, and this may include tracking carbon. This is known as 14C labeling, and many labs will take part in 14C labeling work. But whatever a pharmaceutical lab may be doing on a given work day, proper labeling of products and samples, accurate inventory assessment and tracking, quality assurance, and more must be done so that all finished products are of high quality and no inventory is lost or damaged. This includes getting the correct hardware for testing new pharmaceutical products, from 14C labeling and beyond. But 14C labeling and other work may be supervised when a lab is being inspected.

General Pharma Lab Standards

Unsurprisingly, any laboratory that works with researching, testing, and creating pharmaceutical products will be held to a high standard of GMP, and this is because many millions of Americans today rely on prescription drugs for their health. In fact, many pharmaceutical products are also made for livestock and common pet species, too, such as heartworm medicine for cats and dogs at a vet’s clinic. At work in a pharma lab, even the air itself is held to strict standards, such as in a clean room. For comparison, the ambient outdoor air in a typical outdoor environment has 35 million particles per cubic meter, with each particle being 0.5 micrometers in diameter or greater in this case. By contrast, an ISO cleanroom 1 permits no particles whatsoever in that size range, and only allows 12 particles per cubic meter that are 0.3 micrometers in diameter or under. Even the humidity is a factor to keep careful control of, but the good news is that today’s technology makes such careful control very possible. An American clean room may have its humidity controlled with only a 1% margin of error.

The United States is a world leader in pharmaceuticals. This nation alone is the world’s biggest producer of chemical products, and it alone has 45% of the worldwide pharmaceutical market. Around 810,000 people today are at work at American chemical companies, and that certainly includes the pharmaceutical sector as well. All of these labs must be kept to high standards, however, and that only starts with the aforementioned cleanroom air quality and humidity.

Laboratories will have fume hoods installed in them for a hard day’s work, and these pieces of hardware sometimes need to be replaced. Such hoods should be inspected in person at least once per year by an independent certifier to ensure that the hood has the correct air flow, to meet Cal/OSHA criteria. Meanwhile, a recent survey has shown that one in five American labs today is planning to replace their fume hoods, and one in three of those replacements are due simply to the fume hood’s age. Old, less-functional hardware should be replaced at once so that workplace standards can be maintained.

A pharma lab’s GMP practices may be maintained by other means as well. To keep lab work going smoothly, every staff member’s assigned role and work should be clearly defined and written to avoid any confusion or ambiguity, and this maintains workplace efficiency. What is more, detailed, current, and accurate records should be kept on all activity in the workplace, and these logs may be a useful reference for later. For example, an inspection may be taking place, and these records may be a useful reference to show the inspectors that GMP standards are being adhered to. In other cases, these records may be useful if a customer has a complaint about the products that they received. Those records may prove whether or not the customer’s complaint is accurate, and give the staff a reference so that they know how to avoid such a mistake in the future. This can prevent them from providing sub-standard products to customers over and over.

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