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Requalification, also known as ongoing performance qualification, is when the initial testing of a clean room is repeated to ensure that it continues to meet the same requirements as the facility ages.
Water is a vital component in the pharmaceutical industry’s manufacturing process. Purified water is essential for the production, testing, and analysis of drugs, and ensures that medicines are free from contaminants and meet the appropriate standards for safety and effectiveness. Low quality water can lead to product degradation, contamination, and loss of product and profit.
Water is used for the manufacture of nonsterile pharmaceuticals, for preparation of laboratory reagents and test solutions, and as the final rinse water for equipment that will come into contact with nonsterile products.
Water tests are used to evaluate microbial content and chemical purity of water samples. Potable water is not suitable for general pharmaceutical use because of the considerable amount of dissolved solids present.
Reverse osmosis is often used to produce purified water because of its low cost, efficiency, and ability to protect systems from bacteria and salts.
Water system validation must demonstrate that the water treatment system operates properly and consistently produces water of the desired quality.
Some conditions for water system validation in pharmaceuticals include
Compliance with pharmacopoeia requirements
▪️A proper sampling syste
▪️Detecting and resolving
▪️Contamination problems
In the pharmaceutical industry, there is no set time standard for requalification, but it should be stipulated when a periodic requalification has to be carried out. These requirements should be system-related and risk-based, and in many cases this is every 3 to 5 years.
A detailed review of all changes, trends, and deviations occurring within Annex 2 121 a defined time period may indicate a need for process revalidation.
