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Quality and Compliance – Continuous Environmental Monitoring

Environmental monitoring (EM) is an established method of reducing the risk of contamination of sterile products, and is used by manufacturers in the pharma and associated healthcare industries in the manufacture of advanced medicinal products, as well as in the specialist food industry.

The importance of EM to maintaining the sterility of medicinal products is reflected in the latest EU GMP Annex 1 draft revision, which calls for continuous EM in sectors with stringent environmental control and which carry a risk to public health upon contamination at manufacturing facilities (1).

Why do the latest regulations place such as strong emphasis on continuous EM? The short answer is that it is the most effective way to reduce contamination risk.

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Andy Whittard is the Managing Director at Cherwell Laboratories. Since being appointed MD in 2005 he has overseen significant growth in the business, as Cherwell has focused its offer on cleanroom microbiology solutions for pharma and related sectors. Andy is a Cranfield School of Management Business Growth Programme alumnus, has a background in service and sales, and is part of the second generation in the family business.
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