PIC/S Validation-Master Plan
PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
Short Title: PI 006-3
Origin/Publisher: Secretariat of the Pharmaceutical Inspection Convention c/o EFTA Secretariat 9-11, rue de Varembé, CH - 1211 Geneva 20, http://www.picscheme.org
Document Type: Recommendation
Content: This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics.
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- Pharmaceutical Industry | Regulatory Agency Governance | Quality Systems | Laboratory Systems | Infrastructure: Facilities, Utilities, Equipment | Materials and Supply Chain Management | Sterile and Nonsterile Manufacturing Systems | Filling, Packaging, Labeling | Product Development and Technology Transfer | Safety and occupational health | Environmental safety | Pharmaceutical Validation
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- validation (43) | Cleaning Validation (10) | GMP (8) | Process Validation (8) | Computer System Validation (8) | Equipment Validation (7) | Arabic (7) | Equipment Management (6) | FDA (6) | WHO (5) | Analytical Method Validation (5) | Quality Assurance (3) | manufacturing (3) | formulation (3) | World Health Organization (2) | HVAC (2) | PIC/S (2) | Utilities (2) | synthetic (2) | sterile (2) | Community (2) | day (1) | Pharmacy (1) | European Medicines Agency (1) | factory (1)
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