Once a manufacturing process has been finalized, ProMed will prepare appropriate Quality System documents (SOPs, Batch Records, Material Specifications, Release Specifications) to ensure proper controls are implemented for the following:
- handling, testing and release of incoming materials
- cleanroom monitoring and testing
- equipment operation and cleaning
- process parameters and production step details (Batch Records)
- cleaning
- storage
- product testing, and sample retention
- packaging and sterilization
- labeling
- release
- production employee training
The documents will be prepared to comply with ProMed’s existing Quality System, applicable portions 21 CFR 211, and relevant guidance documents.
