GMP | Manufacturing SOP | Quality Assurance (QA) and Compliance Management | Quality Control (QC) Laboratory | Microbiology Laboratory (Sterility Testing) | GMP Auditor Training | Process, Cleaning, Method Validation | Quality and Validation Guidance | Good Working Practice | Warehouse Management | Standard Operating Procedures (SOP) for Pharmaceuticals.
Step by step pre-written standard operating procedures and manuals in the area of GMP (Good Manufacturing Practice), Manufacturing, Quality Assurance Management, Quality Control Laboratory, Process & cleaning Validation, Regulatory auditing manuals for small and medium size pharmaceutical manufacturing environments.
All manuals and procedures are written by area experts in example formats in order to comply with cGMP, GLP, GDP, GAMP, workplace safety etc. and international regulatory requirements.
Our goal is to provide a complete GMP & GLP model with a set of ready procedures and manuals which are easy to understand and readily applicable. All procedures are written with practical instruction examples and linked with other relevant procedures to have the clear understanding. Procedures are grouped into separate categories and prepared to guide you through establishing a compliant GMP Manufacturing Environment.
Content of our procedures are not only guidelines but a complete set of operating Instructions, Forms and Templates that will help you to build up your systems from today.
Following is a list of manuals and procedures linked with sample pages. For full version of manuals and procedures please read more by clicking the "Subscribe" button on the left.
Part 1 - GMP Guidance (Read Brief Description)
1.1 - Validation Guidance
1.1.1 - Method Validation
1.1.2 - Cleaning Validation
1.1.3 - Other Validation
1.2 - Quality Guidance
1.3 - Aseptic Processing Area Guidance
GMP SOP
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Part 2 - GMP Standard Operating Procedures
2.1 - Validation Procedures SOPs (Read Brief Description)
2.1.1 - Process/Cleaning/Method Validation Procedures
2.1.2 - Computer Validation Procedures
2.1.3 - Validation Templates
2.2 - Quality Assurance and Compliance Procedures SOPs (Read Brief Description)
2.2.3 - Quality Assurance Templates
2.5 - Standard Operating Procedure for Packaging Operation (Read Brief Description)
2.6 - Warehouse Management Procedures SOPs (Read Brief Description)
2.7 - Environmental Health and Safety Procedures SOPs
Part 4 - GMP Manuals (Read Brief Description)
4.1 - Quality Manuals
4.2 - Validation Manuals
4.3 - Laboratory Manuals
4.4 - Operation Manuals
Part 5 - All Quality Forms
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Part 3 - GMP Auditor Training Manuals (Read Brief Description)
