A large proportion of our consultants are deployed in various sites delivering validation, commissioning and qualification scope of work not limited to Equipment Qualification, Process Validation, Cleaning Validation and Analytical Method Validation, Computerized Systems and Software Validation.
Equipment Validation, Facilities and Utilities
We provide high-quality qualification and validation services in the pharmaceutical, biotech, medical devices, diagnostics, consumer products, cosmetics, R&D Labs and veterinary industries. The scale varies from the qualification of a single piece of instrument/equipment to a complete turnkey project. We are often engaged in the validation of start-up facilities, facility expansion, facility and system upgrade or simply annual requalification.
Process Validation combines the actual validated facility, utilities, equipment, and trained personnel with the industrial manufacturing process, control procedures, and components to produce commercial batches. A successful process validation will confirm the process design and demonstrate that future commercial manufacturing process performs as expected. Process Validation will typically have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production. The level of monitoring and testing should be enough to confirm uniform product quality throughout the batch.
The objective of cleaning validation is to provide documented evidence that a specific cleaning process will consistently clean to predetermined limits, to prevent contamination that could adversely affect the safety, efficacy, purity and quality of the products. Therefore, the implementation and validation of cleaning procedures are essential.
Analytical Method Validation
There has been increased regulatory scrutiny on validation of analytical methods. CMC can assist you in the validation of analytical methods to meet ICH standards. We can also support you in the validation of test methods required for your stability studies and cleaning validation studies. Our experts will help you to identify the relevant validation requirements.
Code of Federal Regulations (CFR) 311.165c states that “the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented”. This approach means that the method used in laboratories should not only be reviewed but tested, so they comply with the regulatory specifications. We will help your company develop ways that you can use to verify your product to be of consistent quality from development to production.