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)

Índice de contenido

	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
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	Sterile Production
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	Sterile Production

Sterile Production

Quality Control

Endotoxin testing for injectable products

- water for injection, intermediate and finished product
Always for large volume infusion solutions
Pharmacopoeia method, validated for each product
Failure of the test - investigation
Corrective action

Injectable products should also be tested for Endotoxin levels. This includes tests on Water for injection, intermediate and finished product. It should always be done for large volume infusion solutions.

The Pharmacopoeia method should be used and it should be validated for each product

In case of failure of the test, a thorough investigation has to be done, the cause identified and recorded, and corrective action taken to prevent possible recurrence.