Abstract: Water is a component of every pharmaceutical product, so water system must be validated to ensure the consistent production of high quality water. The pharmaceutical industry places a high priority on the quality of water used in production of finished product, intermediate reagent preparation & analytical processes & especially in case of parenteral products where quality of water must be as per Pharmacopoeia.1,8 In present scenario the quality of pharmaceutical water is maintained by setting a good pharmaceutical water system and this system encompasses system design qualification, attention of the regulatory requirements which are updated time to time. The continuous monitoring of water system is an unequivocal regulatory requirements and a major cost strain on company personnel and resources. Proper water system planning with personnel knowledge in all the physical, chemical, engineering and microbiology issues associated with water is essential.2, 9
A proper pharmaceutical water system must2, 10, 11
1. Achieve & maintain compliance with pharmacopoeia requirements.
2. Have proper sampling system from correct points with appropriate frequency
3. Troubleshoot common contamination problems
4. Consistently produce water that meets industry standards for quality
As with all manufacturing processes evaluation of water system involves three distinct specifications
i. A user requirement
ii. Functional requirement
iii. Design requirement
The User Requirement1 defines the quality of water required by the type of pharmaceutical production process.
The Functional Requirements1 specification describes how the water system will operate these requirements are identified with the goal of identifying system capacity and meeting chemical and microbiological limits. |
