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EU23CEDEC1/SES102 - Validation and Qualification Approach in New Annex 1

‐ Dec 11, 2023 3:00pm

The updated version of Annex 1 further emphasizes validation and qualification in a holistic approach, harmonized with an integrated implementation plan that has its foundation on a partnership between all pharmaceutical departments. Each pharmaceutical process and its respective validation or qualification demonstrate how implementation and adherence to intended purpose need to take into consideration all the product characteristics that have an impact on quality. Minimizing the risk of microbial, particulate, and endotoxin/pyrogen contamination is essential when producing sterile products. These characteristics ought to be studied, controlled, and included in the definition of a control strategy. Several types of sampling tools can be applied to meet these environmental monitoring requirements. Active air sampling is regarded as the most interesting way to collect repeatable samples, possibly with automation, and a single use device could facilitate sample integrity in routine usage. The main driver is always the understanding of the process and a higher predictability of outcomes, which sometimes means faster decision-making paths in case of excursions. A complete qualification is very important for the entire validation process both in terms of accountability and reproducibility from a quality point of view. A deep understanding of your process means that the materials brought in will likely produce a usable and sellable product, limiting the risk of shortages, reducing rejections, and subsequently lowering costs.


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