Case Study: MARCS-CMS 644745 — MARCH 01, 2023
In this Case study following deficiencies in the Water System were observed;
1. The firm could not provide data to demonstrate that the water used to manufacture drug products met the United States Pharmacopeia (USP) monograph for (b)(4) water and was fit for pharmaceutical use.
2. Conductivity and total organic carbon (TOC) testing was not performed.
3.The response was given by the firm but it was found inadequate by the authority because it lacks sufficient information on the planned validation activities, including timelines for completion. In the response firm did not discussed about the TOC and conductivity testing. Which was the observation of the authority.
The Authority requested following in response for the Water System non-compliance;
4.A comprehensive assessment of the water system design, control, and maintenance.
5.A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the (b)(4) system consistently produces water adhering to (b)(4) Water, USP monograph specifications and appropriate microbial limits.
6.Ensure that total microbial count limit for water is appropriate in view of the intended use of the products produced by the firm.
7. A detailed risk assessment addressing the potential effects of the observed water system deficiencies on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that the firm will take in response to the risk assessment, such as customer notifications and product recalls.
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