![]() ![]() Example of Mechanical Demand Specification.Example of Instrumentation Demand Specification.Example of Electrical Demand Specification.Example of Installation Qualification Utilities.Example of Installation Qualification Pipework.Example of Installation Qualification Operating Environment.Example of Installation Qualification HVAC.Example of Installation Qualification Equipment.Example of Design Qualification Protocol.Example of Operational Qualification Report.Example of Installation Qualification Report.Cleaning Validation-Comparative Analysis Template.Cleaning Validation-Rinsing Test Template.For full version of manuals and procedures please read more by clicking the “Join Us” page on the menu. Following is a list of manuals and procedures linked with sample pages. Procedures and manuals are grouped into categories found in a typical GMP environment and documents are prepared to guide you through establishing a regulatory compliant facility.Ĭontent of our procedures are not only guidelines but detail know how instructions which will help you to build up your systems from scratch. Forms and templates are referenced in the SOPs where applicable. All procedures are written with practical instructions and examples. Our goal is to provide a complete GMP & GLP models with a set of ready procedures and manuals which are easy to understand and readily applicable. Step by step pre-written standard operating procedures, forms, templates and manuals in the area of GMP (Good Manufacturing Practice), GLP, Production Operations, Quality Assurance Management, Quality Control & Microbiology Laboratory Process – cleaning and methodology Validation, Regulatory auditing created for small and medium size pharmaceutical manufacturing environments.Īll manuals and procedures are written by area experts in example formats in order to comply with cGMP, GLP, GDP, GAMP and international regulatory agency’s requirements. ![]()
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