THE NEW 2020 DRAFT OF EU GMP ANNEX 1 AND ITS IMPACT ON ACTIVE AIR MONITORING

The EDM 2020 draft of EU GMP Annex 1 has undergone significant changes to incorporate quality management through the introduction of the contamination control strategy (CCS) concept. Environmental monitoring (EM) is the key process measuring the efficiency of the sum of all measures implemented to minimize the contamination risk in the aseptic manufacturing environment. The draft guidance on data integrity and compliance with cGMP (draft guidance 2016) clarifies the role of data integrity in current good manufacturing practice (cGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.

”For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).”

Authorities, such as the FDA, expect data to be reliable and accurate. Companies or Pharmaceutical companies must implement meaningful and effective strategies to manage their data integrity risk based on their process understanding and knowledge management of technologies used.

Click here to learn how you can achieve full data integrity or use the Request Information button below.