Process Validation and Change Control

Process validation and change control is particularly suited to outsourcing, because it places demands on the resourses of a laboratory which are not on-going and which internal laboratories may not have the skills to complete effectively and economically. These activities are critical not only for regulatory compliance, but are also critically important to the quality of the product. Process validation ensures that every dose of every batch meets the product specifications and your company's quality objectives.

Chemika is equipped to use a variety of approaches to cleaning validation. In some situations a non-selective assay such as TOC can be the method of choice. In other cases the selectivity and sensitivity means that chromatographic methods are the only option. Validation or verification of the methodology demonstrates that their performance allows conclusions to be made after completion of the cleaning validation study.

Protocols for cleaning validation can only be finalised after the testing methodology has been established. Chemika works through the analytical approach with the client, ensuring that the testing program is compatible with the objectives of the validation program. Client staff members may be trained and qualified in sampling procedures by Chemika as part of preparation for a sampling program.

Mixing validation can require the testing of a large number of samples to be able to make conclusions which are statistically valid. To be able to make any conclusions from these studies, the performance of the method must be known and quantified. In some cases methods may need to be optimised to achieve the required performance. It is only when adequate method performance has been achieved and measured that value can be obtained from multiple sampling of a process. Chemika understands that reliable analytical data is the foundation for interpretation of mixing validation studies.

Change control includes but extends well beyond mixing validation and cleaning validation. Changes to packaging or ingredients can require additional testing to be able to demonstrate that the product will not be adversely affected by the change. In some cases, the change will require testing to be carried out which may not become part of routine testing, such as testing the quality of a glass vial. In other cases change control will require scientific evaluation of the possible impacts of the change. Chemika is able to assist in developing testing programs which probe possible negative impacts. A risk assessment approach suggest a caution is required, since risks could potentially impact every dose of every batch manufactured.

Working with Chemika, you’re supporting a team with principles, dedicated to meeting your goal of improving the health and happiness, of all people, with nearly 20 years of experience in the area of human healthcare.

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.