WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 13): Good Practices in Production and Quality Control: Good Practices

WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 13): Good Practices in Production and Quality Control
(2006; 30 pages)

Table des matières

Good Practices

Production Operations - Sanitation - IV

Area clearance checks

The area clearance check should be carried out by two people

- between batches of same product, acceptable for both checks to be carried out by production personnel

- for product changeover, second check carried out by QC staff

- all checks carried out in accordance with written SOP and results recorded on the batch documentation.

The area clearance check should be carried out by two people (one performing the check and the other confirming the result). Between batches of the same product, it is acceptable for both checks to be carried out by production personnel. However, where there has been a product changeover as well, the second check should be carried out by QC staff. All checks should be carried out in accordance with a written SOP and the results recorded on the batch documentation and cleaning record. A checklist is very useful for this purpose.

Discuss with the trainees the requirement for QC to do the second check for the area clearance check.