No products
PDA TR 54-4Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug SubstancesReport / Survey by Parenteral Drug Association, 01/01/2015
PDA TR 57-2Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology ProductsReport / Survey by Parenteral Drug Association, 03/01/2015
PDA TR 66Technical Report No. 66, (TR 66) Application of Single-Use Systems in Pharmaceutical ManufacturingReport / Survey by Parenteral Drug Association, 09/01/2014
PDA TR 67Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and CosmeticsReport / Survey by Parenteral Drug Association, 10/01/2014
PDA TR 65Technical Report No. 65, (TR 65) Technology TransferReport / Survey by Parenteral Drug Association, 08/01/2014
PDA TR 69Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing OperationsReport / Survey by Parenteral Drug Association, 06/01/2015
PDA TR 70Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing FacilitiesReport / Survey by Parenteral Drug Association, 07/01/2015
PDA TR 74Technical Report No. 74 (TR 74) Reprocessing of BiopharmaceuticalsReport / Survey by Parenteral Drug Association, 06/01/2016
PDA TR 72Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational GuidanceReport / Survey by Parenteral Drug Association, 10/01/2015
PDA TR 73Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology ApplicationsReport / Survey by Parenteral Drug Association, 10/01/2015
PDA TR 71Technical Report No. 71 (TR 71) Emerging Methods for Virus DetectionReport / Survey by Parenteral Drug Association, 08/01/2015
PDA TR 75Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction FiltersReport / Survey by Parenteral Drug Association, 08/01/2016