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Cleaning validation is a cornerstone of maintaining pharmaceutical safety and product integrity, especially with the updated guidelines in Annex 1 of the EU GMP. The revised Annex 1 emphasizes the need for robust contamination control strategies to prevent microbial, particulate,...
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EMA Unveils Revised Annex 1 in Pharmaceutical Regulation The final version of the EMA revised Annex 1, a monumental achievement in pharmaceutical regulation, was unveiled on August 25, 2022, marking the culmination of a seven-year revision process. The comprehensive changes...
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The pharmaceutical industry is continuously evolving, with innovations and advancements emerging at a rapid pace. One of the critical areas that has seen significant development recently is cleaning validation. Ensuring that manufacturing processes are free from contaminants is essential for...
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The recent updates to the EU GMP Annex 1 shed light on the critical considerations surrounding lyophilization in sterile manufacturing. Lyophilization, often seen as an extension of aseptic processing, introduces unique challenges due to its intricate processes and sensitive product...
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Considering that container performance is the primary trait protecting product safety until the point of use, it will continue to receive increasing regulatory attention in the sterile manufacturing space. The updates to Annex 1 align with the regulatory shifts experienced...
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