Responsibility for complying with the appropriate industry standards ultimately falls on individual companies, divisions, or departments. Failure to comply with current good manufacturing practices (cGMPs) or good laboratory practices (GLPs) can have serious consequences, including regulatory restrictions — such as the inability to sell the product.
It is important that the pharmaceutical company works in conjunction with equipment suppliers to determine the appropriate validation protocols as well as the frequency of requalification. A manufacturer's validation capabilities can be an indicator of the quality of the equipment being supplied.
Water purification systems are essential pieces of equipment in most pharmaceutical laboratories for drug production, drug testing, and quality control applications. The quality of purified water used in these processes ultimately can affect the quality of the final product. This is why organizations such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) frequently state that water purification systems must be validated. As with any other equipment, it is important to work with the water purification system manufacturer to determine the appropriate qualification protocols, how to carry them out, and an appropriate requalification schedule. The manufacturer's knowledge can be crucial, especially if they have developed specific documentation to assist with validation procedures. In addition to meeting cGMP requirements, this documentation also should be applied to each qualification stage and offer users comprehensive help in conducting system qualification.
The engineers who deploy system qualification protocols should be trained in validation procedures and familiar with production processes and regulatory requirements in the pharmaceutical industry. Furthermore, preventive maintenance helps ensure that the water purification system is kept in optimal condition and prevents down-time.
Validation Parameters Since the system qualification begins at the design stage, it is important to have a qualification team involved in the development of all new systems. This enables the manufacturer to incorporate the pharmaceutical requirements for system design and specifications.
Conclusion Equipment validation is essential. Determining what equipment needs validating starts with ascertaining the requirements of the end user. It then proceeds to a risk analysis with careful attention paid to regulatory requirements. Careful choice of an equipment manufacturer that offers a comprehensive validation services program, incorporating specially-trained personnel, on-site qualification protocols, calibrated measuring instrumentation, and the relevant documentation in accordance with GMP requirements can facilitate the validation process and overall regulatory compliance.
Sean Murphy is worldwide validation product manager for the Lab Water Division of Millipore Corporation, Boîte Postale 307, 78054 St. Quentin en Yvelines Cedex, France, (33)1.3012.7232,