cGMP Qualification/Running of Water Systems

Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.

With reference to 21 CFR 211.63, the water system of a pharmaceutical manufacturer has been criticized for its design, control, maintenance and monitoring. In addition to sanitisation deficiencies, several dead legs and threaded pipe connections were reported.

It was also noted that Burkholderia cepacia were discovered in rinse samples of manufacturing equipment. The water system was identified as the source of the contamination. Subsequent sampling indicated the pretreatment of the water and the distribution system to be the cause.

The company produces suppositories and oral solutions and, until recently, nasal solutions. 

The Answer to the FDA Findings

In response to the findings, the company stated that the design of the piping system and fittings, together with the dead legs, contributed to the contamination. The system will be dismantled and replaced by a new one. In the meantime, an "interim water system" will be used.

Requirements of the FDA

In this case, the FDA requires that measures be taken for the interim water system to show that the interim system produces water in accordance with the specifications. In addition, the FDA requests sufficient detailed information about the design, both for the temporary and the replacement water system, as well as the plan for the monitoring and maintenance of each of the systems. In addition, the FDA would like a comprehensive CAPA plan that includes at least

  • blueprints of the water system with identification of all equipment and its construction materials
  • a program showing the effectiveness of the ongoing control, maintenance and monitoring of the system with regard to water specifications
  • changed procedures, resulting from the updating of the water system (at least for sampling with regard to microbiological count and microbial identification).
  • validation reports for the new water system, including validation protocol, all test results and the final result.
  • a list of all products to be manufactured with the interim water system (with distinction between aqueous and non-aqueous dosage forms)

Fore more details please see the complete FDA Warning Letter to Torrent Pharma Inc.

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