Process Validation

PharmaSys can assist your company with process qualifications, provide a turn-key solution for initial validation in preparation for pre-approval inspections or provide revalidation services.

PharmaSys prepares process qualification protocols which provide documented evidence that a process consistently yields results within established USP, company specifications and critical process parameters!

Capabilities

The PharmaSys staff has completed work in various areas of process validation such as:

• Bulk Chemical Process Validations
• Solid dosage packaging lines
• Solid dosage process validation
• Sterilization cycles
• Sterilize-in-place systems
• Biotechnology fermenters.
• Author protocols for solid dosage process validation.
• Author summary reports for completed validation processes.
• Author protocols for the qualification of tablet press and encapsulation equipment when used for specific products.
• Issue reports summarizing the results of engineering studies performed on various processing equipment.
• Investigative review of completed process validation protocols
• Assistance in remediation of concerns related to possible shortcomings in completed validation protocols.
• Batch history research to assure no untoward process trends are notable through the production history of a product from validation to present.
• Technical transfer assistance.

If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.