Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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Page 9 of 54

10 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Validation C ombination products are considered combinations of a device, drug, biologic, or human cells, tissues, or cel- lular or tissue-based products (HCT/P) and are regu- lated by FDA under Code of Federal Regulations (CFR) 21 Part 4, Regulation of Combination Products (1). The guidance states that drugs, biologics, HCT/Ps, and devices—as constituent parts of a combination product—are required to conform to the cur- rent good manufacturing practice (CGMP) regulations pertaining to each constituent part. The guidance also identifies the specific CFR sections for each applicable part. In the European Union, the Eu- ropean Medicines Agency (EMA) has similar directives to regulate constituent parts of combination products. A guide to the regulation for combination product constituent parts and related FDA CGMP regulations is shown in Table I. Due to the complexity inherent in combination products, it is probable that drug sponsors will receive several deficiencies and compliance observations (known as 483 observations in the United States). That is why awareness of how regulatory authorities view method validation and what the common observations are will help sponsors minimize their regulatory risks. Combination product guidance FDA lists specific combination product guidance on its website. Table II cites FDA guidance on combination product development and method validation, specifically or through peripheral reference. Common FDA 483 Observations for Combination Products Adam Lambert Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity. Adam Lambert, PhD, is the VP, product and process development, for Pharmatech Associates, a USP company. WALDEMARUS - STOCK.ADOBE.COM

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