Module 9 2024

03/09/2024

Types of Guidance’s Relevant to Biologicals

• Reflection Papers • Statistical methodology for the comparative assessment of quality attributes in drug development • Q&A • Quality of medicines questions and answers: Part 1/Part 2 • Pharmacopeia • Ph. Eur. 2031 (monograph) – Monoclonal Antibodies for human use

• Ph. Eur. 2.9.20 - PARTICULATE CONTAMINATION: VISIBLE PARTICLES,

• Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26)

• Ph. Eur. 3.2.1 – Glass containers for pharmaceutical use

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Types of Guidance’s Relevant to Biologicals

• Regional (US) • Guidance for Industry (FDA’s interpretation of policy on a regulatory issue) • Bispecific Antibody Development Programs – May 2021 • Inspection of Injectable Products for Visible Particulates – December 2021 • Process Validation: General Principles and Practices January 2011 Rev 1 • cGMP for Phase 1 Investigational Drugs – July 2008 • 21 CFR (Code of Federal Regulations, Title 21 Reserved for Rules of the FDA) • 21 CFR Part 600 Biological Products • USP • USP<1151> Pharmaceutical Dosage Forms • USP<1295800> Glycine • USP<791> General chapter on pH • International • WHO – Technical Report [1998] “Requirements for the use of animal cells as in vitro substrates for the production of biologicals” – Residual DNA levels 10 ng/dose (<200 Da) • International Society for Pharmaceutical Engineering (IPSE) / Parental Drug Association – Industry perspective on matters e.g. visible partlcles in parentals

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