Transcription of Guidelines on good manufacturing practices: …
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Guidelines on good manufacturing practices: …
75 Annex 3 Guidelines on good manufacturing practices : validation, Appendix 7: non sterile process validation1 BackgroundThe appendices of the Supplementary Guidelines on good manufacturing practices : validation currently comprise the following:Appendix 1. Validation of heating, ventilation and air conditioning systems Appendix 2. Validation of water systems for pharmaceutical use Appendix 3. Cleaning validation Appendix 4. Analytical method validationAppendix 5. Validation of computerized systems Appendix 6. Qualification of systems and equipment Appendix 7. Non sterile process validation revised text reproduced in this Annex1. Background and scope 762. Glossary 763. Introduction 784. Process design 805. Process qualification 816. Continued process verification 837. Change management 84 References 851 Supplementary Guidelines on good manufacturing practices : validation.
Annex 3 77 control strategy. A planned set of controls, derived from current product and process understanding that assures process performance and product quality.
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