Regulatory Compliance & Validation SOP Pack

16 editable SOPs: contamination control strategy, media fill, disinfectant and method validation, data integrity, EM qualification, objectionable organisms, inspection readiness, OOS and trending.

What's inside

16 SOPs with all record formats (annexures)
Written against current pharmacopoeia and GMP expectations
Generated as Word (DOCX) with your company details

SOPs in this pack

Handling of Microbial Data Deviations (EM, Purified Water and TOC) · 10 formats
Trend Evaluation of Environmental Monitoring and Water Results
Preparation, Control and Issuance of Protocols and Reports · 3 formats
Analyst and Reviewer Qualification for Microbiological Testing · 12 formats
Handling of Out of Specification Results in Microbiology · 5 formats
Investigation of Environmental Monitoring Excursions · 6 formats
Preparation, Review and Maintenance of the Contamination Control Strategy · 2 formats
Aseptic Process Simulation (Media Fill) · 3 formats
Disinfectant Efficacy Validation · 1 formats
Validation and Verification of Microbiological Test Methods · 1 formats
Data Integrity Controls in the Microbiology Laboratory · 2 formats
Environmental Monitoring Performance Qualification of Cleanrooms · 2 formats
Risk Assessment of Objectionable Micro-organisms in Non-sterile Products · 1 formats
Readiness and Conduct During Regulatory Inspections (Microbiology) · 2 formats
Review and Implementation of Pharmacopoeial and Regulatory Updates · 1 formats
Microbial Identification and Maintenance of the Organism Library · 2 formats

Downloaded from the SOP Builder as Word files with your company name, logo, SOP numbers and sign-off.

How to use these templates

Replace the bracketed fields such as [Company Name] and [SOP No.], check every limit against your product and market, and approve through your own change control before use.