The PDA have released a new technical report of interest: PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes
The purpose of TR 62 is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. TR 62 has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, Investigational New Drug/IMP manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing.
Posted by Tim Sandle