Why GMPs? What are GMPs and Why Do We Need Them? - - BioPharm International


Why GMPs? What are GMPs and Why Do We Need Them?

BioPharm International


cGMP stands for current good manufacturing practices. One heavily debated issue in GMP discussions is to "c" or not to "c". Does GMP = cGMP? Yes.

FDA expects organizations to take the appropriate steps to ensure that the safety, identity, strength, quality, and purity of a drug product is preserved. The scope of GMPs is stated in 21 CFR 211.1(a): "The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals." Also, note the word minimum.

Implementing GMPs GMP implementation never stops, as the GMPs continue to evolve. The stimulus for revision comes from a variety of areas, including FDA observations made during site inspections. Many years ago, as the story goes, an inspector discovered that a manufacturing plant's toilet facilities consisted of an outhouse outside the plant (remember that GMPs came into existence in 1978). The rule addressing this topic now reads as follows:

Sec. 211.52 Washing and toilet facilities. Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas.

As another example, the GMPs did not always say that written procedures were necessary and compulsory. Some enterprising individuals argued that because the regulations did not require that their written procedures be followed, they didn't have to do so. The phrase, "written procedures shall be established and followed for...," now appears in the GMPs at least 100 times.

Implementing revised GMPs can be equally tricky for a newly established organization or one that has been in business for many years. One of the biggest issues is interpreting exactly what the desired outcome of the regulation is. Once that hurdle has been overcome, the next is assessing whether practices to ensure this outcome are already in place. If so, there is no problem. If not, then integrating new practices into an existing way of doing work can be challenging. Rewriting procedures and re-training personnel takes time.

One of the most important ways of reducing implementation challenges is keeping it simple. Making it easy for personnel to comply with internal organizational requirements reduces the risk of an FDA observation reading, "Internal procedures were not followed." Maintaining perspective on the big picture — GMPs define outcomes — will facilitate understanding and long-term compliance with GMPs.

Janet Rose Christensen is vice president, regulatory affairs and quality, AVI BioPharma, One SW Columbia Street, Suite 1105, Portland, OR 97258, 503.227.0554,

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