GMP Validation for Active Pharmaceutical Ingredient (API) Manufacturer

SeerPharma was asked to provide validation management and execution support for an established Active Pharmaceutical Ingredient (API) production facility in Australia.

We were tasked to assist with the:

• Preparation of validation documentation for systems identified as direct impact by the validation master plan (VMP)
• Validation execution training and support for validation activities on systems identified as direct impact by the VMP
• Validation reporting for executed validation activities on systems identified as direct impact by the VMP

SeerPharma was selected because of our proven approach to GMP Validation, including remediation, along with our ability to mentor, provide templates and execute validation tasks as needed. With a current working knowledge of the regulatory framework, we can ease the burden of work and focus on only value-added efforts.

Contact us should you require any assistance with validating your system and procedures to ensure GMP compliance.

This post comes from our July 2015 Journal.