Cleaning and disinfection processes are often undervalued. This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. The pertinent regulations and guidance from EudraLex, PIC/S and the FDA CFRs are summarised. A number of guidance documents from ISO, FDA, PIC/S, USP, PDA and other key opinion leaders are also considered. Some examples of non-compliance (regulatory ‘hot topics’) are highlighted, and recommendations for best practice for cleaning and disinfection processes, personnel and training, documentation and records, cleaning equipment, preparation, use and storage of agents, rotation, transfer disinfection and validation are provided.
Matt Cokely has 10+ years experience within the pharmaceutical industry working as a pharmaceutical microbiologist. He has experience working in graded cleanrooms and in the manufacture of a wide and diverse range of pharmaceutical formats including solid oral dosage units, oral liquids, powders and sterile injectable products. Matt is an invited speaker on international contamination control and regulatory compliance topics, and is a co-opt committee member of the Parenteral and Healthcare Sciences Society (PHSS). He is an IRCA-certified Pharmaceutical Quality Management Systems (PQMS) GMP Provisional Auditor (certification number 6038029) and is completing a CPD log to advance to ‘auditor’ level. In his current role Matt manages the Global Technical Consultant team who deliver site surveys, technical visits and seminars to the Pharmaceutical Industry for Ecolab Life Sciences.