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
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