Environmental Monitoring (EM) is an established method used by manufacturers in pharma and healthcare industries, within the manufacture of advanced medicinal products, and increasingly within cosmetics and toiletries.
The new Annex 1 revision 2022 emphasises the importance of the concept of continuous EM. Continuous EM is the most effective way of reducing contamination risk, which is why these latest regulations in Annex 1 now put such a strong emphasis on its more widespread use.
Planning your EM Programme
The first step for manufacturers when planning for a new continuous EM programme is to conduct an in-depth audit of every aspect of their manufacturing facilities. This should include details of all equipment and processes employed at every stage of the manufacturing process, as well as current protocols for clean room staff in all areas of production.
Other aspects that must be evaluated at this stage include the effectiveness of detection systems in alerting operators to ongoing contamination, training, and behaviour of staff at facilities and the suitability of current SOPs. The local flora shall be reviewed for changes on a predetermined frequency by Quality Control and Quality Assurance Departments.