Pharma Fundamentals: Risks and Regulations for Hold Times in Biopharmaceuticals

In the previous episode of PharmTech’s Pharma Fundamentals video series, Robert Dream, managing director of HDR Company and member of PharmTech's editorial advisory board, provided an overview and definition of hold times in biopharmaceutical manufacturing. In part 2, Dream goes into further depth about the regulations involved and the risks that should be mitigated.

According to Dream, there is no single universal regulatory limit for biopharmaceutical hold times. Regulatory agencies, both in the United States and the European Union, expect pharmaceutical companies to establish, scientifically justified, validated, and documented hold times that ensure product quality, safety, and efficacy throughout the manufacturing process.

Key Regulations for Hold Times

Key regulations and guidelines regarding hold times include current good manufacturing practice (GMP) regulation 21 Code of Federal Regulations (CFR), Parts 210 and 211, in the US; International Council for Harmonisation (ICH) Q7, Q8, Q9, and Q10 guidelines; the European GMPs, EudraLex; and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guides. In addition, regulatory agencies expect hold time studies to be incorporated into process validation or documented as separate studies where appropriate.

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