The ISO 9001 standard for Quality Management Systems first called for manuals in pharma as part of its requirements. Top-level publications that outline a company’s Quality Management System are called quality manuals (QMS). Both internally (for staff) and externally are possible uses for it (for customers and auditors).
The pharmaceutical manufacturer creates the Site Master File (SMF), which should include details about the site’s quality management policies and practises, the production and/or quality control of pharmaceutical manufacturing operations performed at the named site, and any closely integrated operations at nearby and adjacent buildings. An SMF only needs to define those procedures, such as analysis, packing, etc., if only a portion of a pharmaceutical operation is performed on the site.
Water System Validation Plan provides a detailed view into the technical aspects, testing, validation and reporting pattern for “water”. It further reinforces the company’s commitment to maintain GMP.
The water plant is to provide the total amount of Purified water & water for Injection required for the Formulation Plant. The plant produces water suitable for pharmaceutical use, i.e. so-called Purified water & water for Injection quality as per WHO specifications which must quality pH ,Calcium & Magnesium, Heavy metals , Chloride , Nitrate , Sulphate ,TOC, Conductivity, Microbial counts, Bacterial Endotoxin Test ,etc. by means of new Generation Plant.
The plant must comply with the requirements of the pharmacopoeia and the cGMP regulations as well as with WHO inspection regulations for plants producing Purified water & water for Injection.
