Program Overview:
The cleaning of facilities and equipment is a critical activity to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. The residuals of active, detergent, toxins and excipients are increasingly deviations in inspections and audits. The cleaning and sanitation procedures need to be validated to demonstrate effective cleaning and sanitation program for facility, utility, equipment, health and hygienic practices.
Program Modules:
Module 1
- Pharmaceutical Sanitation Programs
- Generic Sanitation Program
- Sanitation Validation/Verification
- Cleaning validation Requirements
Module 2
- Pre-operational Sanitation Assessment
- Operational Sanitary Practices
- Personnel Health and Hygiene
- Premises Sanitation Requirements
Module 3
- Sterile Validation
- Types of Sterilization
- Process controls
- CIP/SIP
Module 4
- Cleaning Verification and Cleaning Validation
- Cleaning Master Validation Plan
Module 5
- Preparing for Cleaning Validation
- Process controls
- Writing cleaning validation protocol
- Writing cleaning validation report
- Case study
Module 6
- Effective sanitation program
- Gap Analysis
- Dirty hold time studies
- Clean hold time studies
- Deviations/CAPA/Change Control
Module 7
- Writing cleaning validation protocol
- Writing cleaning validation report
- Case study
