In the pharmaceutical industry, cleaning processes are vital, especially when dealing with equipment that cannot be effectively cleaned without disassembly. This is where the Clean-Out-of-Place (COP) method becomes essential. COP involves removing and disassembling equipment parts, which are then cleaned...
- 19 August 2024
- 2 Min Read
𝗖𝗹𝗲𝗮𝗻-𝗶𝗻-𝗣𝗹𝗮𝗰𝗲 (𝗖𝗜𝗣) is a fundamental cleaning method used in pharmaceutical manufacturing to ensure equipment is cleaned without the need for disassembly. This process is vital for maintaining hygiene, preventing cross-contamination, and ensuring that pharmaceutical products meet stringent safety and quality...
- 9 August 2024
- 2 Min Read
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,...
- 4 July 2024
- 2 Min Read
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...
- 21 June 2024
- 2 Min Read
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...
- 19 June 2024
- 3 Min Read
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...
- 14 June 2024
- 2 Min Read
