The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...
Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...
SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that Rottendorf Pharma, a prominent contract ...
Validation engineers design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. Natural problem-solvers, ...
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