Pharmaceutical Validation and Process Controls in Drug Development
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
PHARMACEUTICAL VALIDATION AND PROCESS CONTROLS IN DRUG DEVELOPMENT SHEIN-CHUNG CHOW,PHD Executive Director, Biostatistics and Data Management, Covance, Inc., Princeton, New Jersey
In drug development, pharmaceutical validation and process controls are important to assure that the drug product can meet standards for the identity, strength, quality, purity, and stability of the drug product. Pharmaceutical validation includes analytical method validation and (manufacturing)process validation. A validated analytical method is ofen employed for product testing at various critical stages of a manufacturing process to evaluate whether the manufacturing process does what it purports to do. For a validated manufacturing process, the current good manufacturing practice requires that a wellwritten procedure for process controls be established to monitor the performance of the manufacturing process. In this papel; statistical issues and regulatory requirements for pharmaceutical validation and process controls in drug development are discussed. The concept can be applied to new drugs, new dosage forms, and generic drug development.
Key Wordr: Assay validation; Process validation;Quality assurance; United States pharmacopeia tests; Release targets
INTRODUCTION
trols are important to assure that the drug product at various stages of drug developTHE DEVELOPMENT OF A drug product ment can meet standards for the identity, is a lengthy process which involves drug disstrength, quality, purity, and stability of the covery, laboratory testing, animal studies, drug product. Note that the standards are usuclinical trials, and regulatory registration. ally referred to as the standards specified in This lengthy process is necessary to ensure the United States Pharmacopeia and National the effectiveness and safety of the drug prodFormulary (USP/NF) (1). uct. After the drug is approved, most regulaPharmaceutical validation includes the tory agencies such as the United States Food validation of laboratory instruments such as and Drug Administration (FDA) also require gas chromatography (GC) and high-perforthat the drug product be tested for its identity, mance liquid chromatography (HPLC) or anstrength, quality, purity, and stability before alytical methods developed based on these it can be released for use. For this purpose, instruments and manufacturing processes for Pharmaceutical validation and process conspecific compounds. The current good manufacturing practice (cGMP) requires that the sponsors establish the reliability of test rePresented at the DIA “First International Taipei Sympo- sults through appropriate validation of the sium,” August 29-30, 1996, Taipei, Taiwan. test results at appropriate intervals (21 CFR Reprint address: Shein-Chung Chow, PhD, Biostatistics and Data Management, Covance, Inc., Princeton, 210 and 211). More specifically, the cGMP requires that the accuracy and reliability of NJ 08540. 1195 Downloaded from dij.sagepub.com at UNIV CALIFORNIA
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