Validating cleaning procedures protein toc
There should be a justified validation programme for this approach referred to as “bracketing”, addressing critical issues relating to the selected product, equipment or process.4.1.6 Bracketing by product should be done only when the products concerned are similar in nature or property and will be processed using the same equipment.
Identical cleaning procedures should then be used for these products.4.2.1 The relevant cleaning records (signed by the operator, checked by production and reviewed by quality assurance) and source data (original results) should be kept.
Traces of the preceding products should be sought in these samples.
This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations.
If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.
Know about the procedure for cleaning validation and cleaning validation protocol and reports as per WHO.
Method of sampling, Analytical methods and limits of recovery of swabs.