(1999; 168 pages) [Spanish]
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: