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Challenges of cleaning and its validation

  • Rob Walker
  • Director
  • Rob Walker GMP Consultancy Limited, United Kingdom

Cleaning and cleaning validation are key activities within the Pharmaceutical and other Industries. Whilst regulatory standards can and do specify acceptance criteria and associated limits the practicalities of achieving compliant levels of cleaning and validating the same are often left to companies and their own experts. Different types of cleaning practices can be used to meet these global regulatory standards however these practices should also ensure that operational activities are still capable of meeting the increasing demands of efficiency and throughput.

The various Regulatory Agencies around the world have different approaches to cleaning and cleaning validation. Some agencies specify limits and acceptance criteria whilst others do not. What is common to all of them is that they expect cleaning to be carried out by trained staff, following detailed procedures, which result in product contact equipment being cleaned to an acceptable standard.

It is recognised by all major agencies that cleaning is the start of the manufacturing process for the next product and there will be a level of carryover of the previous product to the next product when non-dedicated equipment is used for the manufacture of pharmaceutical products. The specific requirements for the different agencies are discussed during the training providing background information to the challenges of cleaning and its validation.