I discussed shortly....
A consumer usually can't detect that a drug product is safe or if it will work.
While cGMP require testing, testing alone is not adequate to ensure
quality. In most instances testing is done on a small sample of a batch (for
example, a drug manufacturer may test 100 tablets from a batch that contains 2
million tablets), so that most of the batch can be used for patients rather
than destroyed by testing. Therefore, it is important that drugs are
manufactured under conditions and practices required by the cGMP regulations to
assure that quality is built into the design and manufacturing process at every
step. Facilities that are in good condition, equipment that is properly
maintained and calibrated, employees who are qualified and fully trained, and
processes that are reliable and reproducible, are a few examples of how cGMP
requirements help to assure the safety and efficacy of drug products.
No comments:
Post a Comment