Pharmaceutical GMP Inspections
GMP is a concept of “Quality Assurance” to cover all aspects which may individually or collectively have an impact on the quality of the product during manufacture. Drugs and drug products are manufactured using a drug process with many physical operations. Control of these physical operations and compliance with GMP help to ensure the products are consistently produced and are safe, have the identity and strength, and meet the quality and purity characteristics as intended.
Like many laws and regulations, Good Manufacturing Practices (GMP) were developed and strengthened in various countries based on tragedies and industrial experiences over time. (Below: an example of the historical tragedies in the US).
The 2 GMP standards currently most influential to the world’s pharmaceutical industry are undoubtedly the US and the EU GMP guidelines. Inspections at the pharmaceutical firms are conducted by the regulatory authorities of both the EU and the US to monitor compliance with GMP. For more details, please Pharmaceutical GMP Inspections (PDF 36 KB)
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