WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Close this folderAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
View the document1. General considerations
View the document2. Glossary
View the document3. Self-inspection and quality audits
Close this folder4. Equipment
View the document4.1 Use of equipment
Close this folder4.2 Cleaning programme
View the document4.2.1 Detailed cleaning procedure
View the document4.2.2 Sampling plan
View the document4.2.3 Analytical methods/cleaning limits
Open this folder and view contents5. Materials
Open this folder and view contents6. Documentation
Open this folder and view contents7. Good practices in production and quality control
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

4.2 Cleaning programme

Where multipurpose equipment is in use, it is important to be able to determine previous usage when investigating cross-contamination or the possibility of such contamination. An equipment cleaning and use log, while desirable and perhaps preferable, is not the only method of determining prior use. Any documentation system which clearly identifies the previous batch and shows that the equipment was cleaned is acceptable. For operations where multiple grades of the same chemical entity are processed, there must be documentation showing that the previous grade was removed. Validation data must exist to prove acceptability of the cleaning procedure.

Cleaning of multiple-use equipment should be confirmed. The manufacturer should determine the effectiveness of the cleaning procedure for each excipient or intermediate chemical used in that particular piece of equipment. The validation data required depend on the types of materials being made in the multiple-use equipment and the impact of trace contaminants on drug safety and performance. Validation data should verify that the cleaning process has removed residues to an acceptable level.

As an example, an equipment cleaning programme may include, but is not limited to, the following:

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