Documentation Templates for GMP Systems and Processes
We have a library of GMP documentation templates that may be used “as is” or modified to suit your company’s operating systems and processes. We can also prepare documentation that is tailored to suit your specific and exacting requirements.
- Standard Operating Procedures (SOPs) for:
- Quality Assurance (QA).
- GMP Manufacturing.
- GMP Packaging.
- GMP Systems and Processes.
- GMP Warehousing.
- Factory and equipment maintenance.
- Quality Control (QC).
- Microbiology.
- Stability and product quality monitoring.
- Production planning and logistics.
- Site Master File.
- Quality Manual.
- Validation Master File.
- Validation templates.
- Specification templates for profiles on Product, Packaging, Test Specifications and Stability.
- PQR – Product Quality Review (Annual Quality Review).
- Manufacturing and Packaging document templates.
- Warehousing.
- Good Distribution Practices (GDP) and Good Warehousing Practices (GWP).
- GMP agreement.
- Confidentiality/NDA agreement.
- Batch Manufacturing and Batch Packaging Checklists.
- Production, QA and QC Forms.