WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products: Sterile Production

WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)

Table des matières

	Basic Principles of GMP
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production

Sterile Production

Sterilization by Filtration (2)

Validation to include

- time taken to filter a known volume

- pressure difference to be used across the filter
Significant differences to be noted and investigated, recorded in batch records
Integrity of gas and air vent filters checked after use, other filters at appropriate intervals

Validation should include the time taken to filter a known volume of product and the pressure difference to be used across the filter. If during routine production, any significant differences are noted, these should be investigated, and recorded in batch records.

Integrity of gas and air vent filters should be checked after use, and other filters at appropriate intervals