𝗪𝗵𝘆 𝗶𝘀 𝘁𝗵𝗲 𝘄𝗮𝘁𝗲𝗿 𝘀𝘆𝘀𝘁𝗲𝗺 𝗿𝗲𝗾𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗶𝗻 𝘁𝗵𝗲 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆?

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 system

▪️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.