More than 2900 warning letters have been issued to the companies due to the non-compliances due to Water System. Although discussing all those non-compliances with you on this platform is practically difficult but I feel that few of them can be discussed and we can take few learnings which if implemented can save our site from many non-compliances & hence WLs.
We are discussing the topic of Water since last four articles. Discussed the cGMP mistakes/ non-compliances done by many firms which lead to issue them Warning letters.
I feel still we should discuss more case studies about the water. As if the quality of water is not as per the requirements your all efforts irrespective any level of compliance you are following on your site will go in vain.
Lets discuss more case studies;
4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
1. The firm failed to adequately validate the manufacturing process and water system used in the manufacture of the hand sanitizer and antibacterial hand soap drug products. For example, batch records included unvalidated in-process adjustments, such as adding (b)(4) as-needed if the density of your antibacterial hand soap was low.
2. The firm did not demonstrate that it's manufacturing processes were controlled to consistently yield a drug product of uniform character and quality.
3. Furthermore, the firm has not validated the water system, does not maintain procedures, and did not provide specifications upon request by investigators.
4. Firm lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.
Summarize all the gaps discussed in these 5 articles and check on your site whether these non-compliances are there on your site?
If yes then make the plan of action and remove them with proper procedure.