Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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12 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Validation In addition to the information provided by FDA, quality guidelines and standards are also published by the United States Pharmacopeia, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the International Society for Pharmaceutical Engineering, the Paren- teral Drug Association, the International Organiza- tion for Standardization, and the American National Standards Institute for validation of methods. For Europe, EMA released guidance for combi- nation products, titled Guideline on Quality Docu- mentation for Medicinal Products When Used with a Medical Device, that was adopted by The Committee for Medicinal Products for Human Use for publica- tion on July 22, 2021 and effective Jan. 1, 2022 (2). Table I. Regulations for constituent parts of combination products. Constituent part FDA Current Good Manufacturing Practice Regulations Drugs 21 Code of Federal Regulations (CFR) Part 210 and 211 Biologics 21 CFR Parts 600-680 Medical devices 21 CFR Part 820 HCT/Ps (human cells, tissues, or cellular or tissue-based products) 21 CFR Part 1271 Table II. FDA guidance documents for combination products that can impact method validation. Guidance Issue date Topic Requesting FDA Feedback on Combination Products: Guidance for Industry and FDA Staff 12/04/2020 Biologics, combination products, drugs, medical devices, over-the-counter drugs Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration 07/29/2020 Post-market, pre-market, biologics, combination products, drugs, medical devices, digital health Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff 04/21/2020 Biologics, combination products, drugs, medical devices Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry 12/19/2019 Biologics, combination products, drugs, medical devices Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry 02/15/2019 Biologics, combination products, gene therapy, medical devices Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff 02/06/2019 Biologics, combination products, drugs, medical devices Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry 10/03/2018 Biologics; chemistry, manufacturing, and controls; combination products; drugs; medical devices; pharmaceutical quality Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff 01/12/2017 Investigation and enforcement, biologics, compounding, CGMP, drugs, medical devices, pharmaceutical quality Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff 12/27/2016 Post-market recalls, adverse event reporting system (FAERS), 510(k), adverse event reporting, combination products, investigational device exemption (IDE), laser notice, medical devices, premarket approval (PMA), safety - issues, errors, and problems, humanitarian use device/humanitarian use exemption (HUD/HDE) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff 02/03/2016 Biologics, combination products, drugs, medical devices Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff 06/07/2013 Administrative/procedural, biologics, combination products, drugs, medical devices Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document 03/27/2008 Combination products, drugs, medical devices, cardiovascular

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