Cleaning validation is performed to ensure that the equipment cleaning process will consistently reduce the possibility of crosscontamination via carryover in a drug manufacturing process.
It provides documented evidence that an approved cleaning process will reproducibly remove previous products, by-products of concern or cleaning agent residues that may remain on the equipment to below scientifically set limits.
These limits are calculated based on safe threshold values, which are determined by toxicological evaluation.
All cleaning processes for product contact equipment should be validated in accordance with Quality Risk Management (QRM) principles.
Consideration should also be given to non-contact parts from which product may migrate. These should be based on risk assessment.
Remediation actions must be implemented when a cleaning process is not capable of consistently producing adequate results. Examples of remediation actions include improved cleaning procedures and equipment/facility dedication.
Continued cleaning failures and/or testing until clean (i.e. continually cleaning and testing until acceptable results are achieved) are not acceptable.
It is also important to demonstrate that the facility and equipment are designed, cleaned and used in a manner that will prevent microbial contamination of products.
This guide (GUI-0028) addresses special considerations and issues when validating cleaning procedures for equipment used to fabricate and package:
- active pharmaceutical ingredients (APIs)
- pharmaceuticals
- radiopharmaceuticals
- biological drugs
- veterinary drugs
This guide is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures. Principles incorporated in international guidance have been taken into account when preparing this document.
It covers validation of equipment cleaning for the removal of residues associated with products used in the previous production run, such as active ingredients, breakdown or by-products of concern, intermediates, residues of cleaning agents, and processing agents and potential microbial contaminants.