What’s up with Cleaning Validation?

If you follow us regularly, you know that on 12 October our Technical Director, Ana Gonçalves, will talk about Good Manufacturing Practices (GMP) during the Sophidis Days, in Tunisia. One of the topics that will be addressed is Cleaning Validation, but what is it really?

Cleaning Validation is the most important feature of your process, essential for the owner of a drug to allow you to produce it. This is because most pharmaceutical production facilities are multi-product areas and use a wide range of equipment. This in itself demonstrates the importance of facility and equipment cleaning, as avoiding cross product contamination is a must, in pharmaceutical production.

However, you cannot have one procedure for each cleaning, to achieve a correct Cleaning Validation. Instead, the procedures must take into account all production processes manufactured on the equipment, must be integrated into your processes and be subject to detailed inspections and data collection. In addition, do not forget that a procedure maintenance strategy is required to enable validated production in an efficient and cost-effective manner.

This is a core activity in your quality process, so if you need more detailed information, advice on your process or training, contact us. RC REDOL can help you achieve the desired cleaning validation models for your production facilities, creating procedures and normative information for your company. We develop protocols and reports with your data, both for analysis and to prove your Cleaning Validation system. This way, your production will be ready for customer inspections and regulatory audits, a crucial step for continuity, in the production of pharmaceutical products.

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