Rethinking Cleaning Validation for API Manufacturing

Cleaning validation is a regulatory requirement worldwide and an integral process step within the manufacturing of active pharmaceutical ingredients (APIs) and drug products. The approach of designing, qualifying, and monitoring a process is labelled a lifecycle approach. This article focuses on app...

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Bibliographic Details
Published inPharmaceutical technology Europe Vol. 30; no. 9; pp. 20 - 32
Main Authors Zhang, Chunfen, Hadziselimovic, Dijana, Thanavaro, Amy, Aina, Adeyinka, Edlin, Chris, Lopolito, Paul
Format Journal Article
LanguageEnglish
Published Monmouth Junction UBM LLC 01.09.2018
MultiMedia Healthcare Inc
Subjects
Backup software
Biological products
Bupivacaine
Ciclesonide
Discount coupons
Drugs
Encyclopedias
Ethanol
Laboratories
Manufacturers
Manufacturing
Pharmaceutical industry
Pharmaceutical sciences
Pharmaceuticals
Pharmacology
Production management
Production processes
Regulatory compliance
Toxicology
Water quality
Ireland
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Summary:Cleaning validation is a regulatory requirement worldwide and an integral process step within the manufacturing of active pharmaceutical ingredients (APIs) and drug products. The approach of designing, qualifying, and monitoring a process is labelled a lifecycle approach. This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
ISSN:1753-7967