GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS - ANNEXES - Annex 1 - Manufacture of sterile medicinal products

Sep 14, 2026

PIC/S GMP Guide Annexes provide detailed requirements and implementation guidance for specific manufacturing scenarios within medicinal product production. Annex 1 focuses on the manufacture of sterile medicinal products, covering scope and core principles, Pharmaceutical Quality System elements, premises and barrier technologies, qualification of cleanrooms and clean air equipment, and controls for disinfection, utilities, water, steam, and gas systems. It further addresses sterile production technologies including aseptic preparation, filtration, FFS and blow-fill-seal, lyophilization, closed and single-use systems, environmental/process monitoring, aseptic process simulation, and quality control, plus supporting definitions.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages284

Reading Time11 h 56 min

AccessFree to download

Annexes

Annex 1 (Manufacture of sterile medicinal products)

Annex 2A (Manufacture of advanced therapy medicinal products for human use)

Annex 2B (Manufacture of biological medicinal substances and products for human use)

Annex 3 (Manufacture of radiopharmaceuticals)

Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)

Annex 5 (Manufacture of immunological veterinary medical products)

Annex 6 (Manufacture of medicinal gases)

Annex 7 (Manufacture of herbal medicinal products)

Annex 8 (Sampling of starting and packaging materials)

Annex 9 (Manufacture of liquids, creams and ointments)

Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation)

Annex 11 (Computerised systems)

Annex 12 (Use of ionising radiation in the manufacture of medicinal products)

Annex 13 (Manufacture of investigational medicinal products)

Annex 14 (Manufacture of medicinal products derived from human blood or plasma)

PE 009-17 (Annexes) 25 August 2023 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES © PIC/S 2023 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat 14 rue du Roveray CH-1207 Geneva e-mail: [info@picscheme.org](info@picscheme.org) web site: [https://www.picscheme.org](https://www.picscheme.org) ANNEXES Annex 1 (Manufacture of sterile medicinal products) 1 Document map 1 Scope 2 Principle 2 Pharmaceutical Quality System (PQS) 5 Premises 6 Barrier technologies 9 Cleanroom and clean air equipment qualification 12 Disinfection 15 Equipment 16 Utilities 17 Water systems 18 Steam used as a direct sterilising agent 19 Gases and vacuum systems 20 Heating and cooling and hydraulic systems 20 Personnel 20 Production and specific technologies 24 Terminally sterilised products 24 Aseptic preparation and processing 24 Finishing of sterile products 27 Sterilisation 29 Sterilisation by heat 32 Moist heat sterilisation 32 Dry heat sterilisation 34 Sterilisation by radiation 35 Sterilisation with ethylene oxide 35 Filter sterilisation of products which cannot be sterilised in their final container 36 Form-Fill-Seal (FFS) 40 Blow-Fill-Seal 42 Lyophilization 45 Closed systems 46 Single Use Systems (SUS) 47 Environmental and process monitoring 48 General 48 Environmental and process monitoring 49 Environmental monitoring – total particle 50 Environmental and personnel monitoring – viable particle 52 Aseptic process simulation (APS) (also known as media fill) 54 Quality control (QC) 59 Glossary 61 Annex 2A (Manufacture of advanced therapy medicinal products for human use) 68 Scope 68 Principle 72 Part A: General guidance 73 Supplimentary provisions to PIC/S GMP Guide Part I 74 Chapter 1 Pharmaceutical quality system 74 Chapter 2 Personnel 74 Chapter 3 Premises and equipment 75 Chapter 4 Documentation 79 Chapter 5 Production 80 Chapter 6 Quality control 91 Chapter 7 Outsourced activities 96 Chapter 8 Complaints and product recall 97 Part B: Specific guidance on selected product types 98 Common glossary to Annex 2A and 2B 101 Annex 2B (Manufacture of biological medicinal substances and products for human use) 108 Scope 109 Principle 110 Part A: General guidance 112 Personnel 112 Premises and equipment 112 Animals 115 Documentation 116 Production 116 Starting and raw materials 117 Seed lot and cell bank system 119 Operating principles 120 Quality control 122 Part B: Specific guidance on selected product types 123 Annex 3 (Manufacture of radiopharmaceuticals) 128 Principle 128 Introduction 128 Quality assurance 129 Personnel 130 Premises and equipment 130 Documentation 131 Production 131 Quality control 132 Reference and retention samples 134 Distribution 134 Glossary 134 Annex 4 (Manufacture of veterinary medicinal products other than immunologicals) 135 Manufacture of premixes for medicated feeding stuffs 135 The manufacture of ectoparasiticides 136 The manufacture of veterinary medicinal products containing penicillins 136 Retention of samples 136 Sterile veterinary medicinal products 136 Annex 5 (Manufacture of immunological veterinary medical products) 137 Principle 137 Personnel 137 Premises 138 Equipment 141 Animals and animal houses 142 Disinfection Waste disposal 142 Production 143 Starting materials 143 Quality control 146 Annex 6 (Manufacture of medicinal gases) 147 Principle 147 Manufacture of active substance gases 147 Manufacture of medicinal gases 148 Personnel 148 Premises and equipment 149 Documentation 150 Production 151 Quality control 154 Transportation of packaged gases 155 Glossary 156 Annex 7 (Manufacture of herbal medicinal products) 158 Principle 158 Premis

FAQs

How does Annex 1 address control and verification of aseptic processes?

It includes environmental and process monitoring (particle counts and viable particles), aseptic process simulation (media fill), general environmental monitoring items, and links to quality control elements and definitions via the annex structure.

Sep 14, 2026

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