ResourceEnvironmental
Changes to GMP Force Cleanroom Re-Classifications
9 May 2017This whitepaper details the changes to ISO 14644-1, an ISO standard for GMP cleanrooms. It advises how these changes will impact cleanroom users in the GMP community and explains the steps you may need to make to comply to the revised standard. These changes include incorporating a larger number of sampling points into cleanrooms and ensuring that particle counters used to monitor cleanrooms are compliant with the requirements of ISO 21501-4.
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Environmental Monitoring and TestingEnvironmental monitoring and testing uses handheld portable analyzers, kits, spectrometers or chromatography systems for air, water, soil, food and other sample testing. Useful features of analyzers such as BOD and COD include portability, easy calibration, automation and sensitivity. Environmental test kits for pH, water, moisture, etc, should be accurate, sensitive, reliable, fast and easy to use.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Environmental ContaminationContaminants in the environment are harmful chemicals that are present in the air, land and water. These include pesticides, pharmaceuticals, persistent organic pollutants (POPs) and many more.ISO CertificationGood Manufacturing Practice