SCA Pharma is committed to Quality by Design combining Quality Standards with a comprehensive PQS (Pharmaceutical Quality System) which is implemented throughout the different stages of a product’s lifecycle.
We place an equal importance on every step of the compounding process from receipt and storage of materials, to batch record preparation, through compounding, inspection and testing to shipping.
Our Quality system validates every step of the process to ensure compliance with FDA regulations and guidelines to ensure we uphold the ethical standards of our industry while providing the safest possible products for your patients.
SCA Pharma facilities are registered with the FDA as 503B Outsourcing facilities. As a result, we adhere to:
- FDA 503B GMP Guidance Requirements
- Part 211 GMP requirements, and
- 2004 Aseptic Processing Guidance for the manufacturing industry.
SCA Pharma operates according to cGMP which expands the standards of safety and quality beyond that of USP <797>, and safeguards that our organization is exceeding the expectations defined in USP <797>.
By adhering to the 503B Guidance, SCA Pharma meets or exceeds the expectations defined in USP <797>.