Water system qualifications

What is frequency for requalification of purified water system?

Requalification of Purified water system should be carried out whenever there are major changes made in the stages like pre-treatment, purification steps, generation, Loop system, Addition of new user points in the circulatory loop system, replacement of major component(s) which may have a direct impact on quality of output water.

The scope and extent of re-qualification should be determined based on risk assessment. The system should be subject to continuous monitoring.

WPU systems should be reviewed at described intervals (e.g. annually).
The review should be documented.

The review team should be comprised of representatives from, for example,
engineering, utilities, validation, QA, quality control, microbiology, production and maintenance.

Examples of matters to be included in the review are:
■■ changes made since the last review;
■■ system performance trends and capability;
■■ quality trends;
■■ failure events and alarm history;
■■ investigations;
■■ out-of-specification and out-of-limit results;
■■ alert and action limits;
■■ assessing compliance with current GMP requirements for WPU
■■ verification of documentation being current;
■■ maintenance and calibration history;
■■ records such as logbooks and electronic data; and
■■ the appropriateness of the software and the computerized system linked to the water system, for example, SCADA (Supervisory Control and Data Acquisition), including audit trail, authorized
users with access and privileges.

Reference: WHO Guidelines, WHO Expert Committee on Specifications for Pharmaceutical
Preparations, 55th report, TRS-1033:2021,
Annex 3, Good manufacturing practices: water for pharmaceutical use

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Thank you Sir…

You are always welcome.

Dear Sir,
one more question is that when the finished product batches samples to be kept in stability chamber for stability study? Immediately after completion of packing process OR after QC release of that finished product batches?
Please also provide reference for the same.

Dear sir,
I awaiting for your reply.

Generally, the samples of the finished product batch should be kept on stability studies in the stability chambers after QC/QA release of that batch. And QC / QA release of the batch must be completed within 1-2 weeks from the date of packing. This is an industrial practice followed for stability studies. There are no specific regulatory guidelines for this.

The initial date of storage should be considered t-0 and stability time points should be defined as a date with respect to t-0. For example, if t-0 is 1 January 2020 then the one-month time point corresponds to either 1 February or 31 January 2020. For each time point, samples should be withdrawn and tested as per the protocol. Testing should be completed as soon as possible. Deviations from the protocol should be recorded and justified.

Reference:- WHO Guidelines, TRS 1010 -2018, Annexure 10
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

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Thank you very much sir…

You are always welcome.