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International GMPs
Introduction
By Michael H. Anisfeld, Senior Consultant, Globepharm Consulting, Deerfield, IL, USA
At its very simplest, Good Manufacturing Practices (GMPs) are a legal codification of sound quality principles applied in the manufacturing and testing of pharmaceutical products (“medicinal products” in European terminology, “drug products” in United States terminology). GMPs are intended to assure that:
- Raw materials used in the manufacture of drugs are of known, and of possibly standardized, quality and are free from contamination;
- The manufacturing process has been proven to produce a pharmaceutical product meeting its quality attributes;
- Adequate quality control testing measures have been employed to assure that the product meets its quality specifications at time of release to market, and at the end of its shelf life.
GMPs grew out of the realization that end-point quality testing was insufficient to assure the quality of the individual medication unit (the tablet, the capsule, the vial) dispensed to the patient, but rather quality needed to be assured at each step of the manufacturing process to be as certain as possible that each dosage unit met its quality specifications. Prior to this realization, pharmaceutical product quality was assured by pharmacopoeal “end point” testing.
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