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PDA TR 56
PDA TR 56Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)Report / Survey by Parenteral Drug Association, 11/01/2016
$195.00 $325.00 -40%Reduced price!In stockPDA TR 78
PDA TR 78Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage FormsReport / Survey by Parenteral Drug Association, 01/01/2018
$195.00 $325.00 -40%Reduced price!In stockPDA TR 77
PDA TR 77Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal TechnologyReport / Survey by Parenteral Drug Association, 02/01/2017
$195.00 $325.00 -40%Reduced price!In stockPDA TR 76
PDA TR 76Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral PackagingReport / Survey by Parenteral Drug Association, 10/01/2016
$195.00 $325.00 -40%Reduced price!In stockPDA TR 75
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
$195.00 $325.00 -40%Reduced price!In stockPDA TR 60-2
PDA TR 60-2Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage FormsReport / Survey by Parenteral Drug Association, 03/01/2017
$195.00 $325.00 -40%Reduced price!In stockPDA TR 54-5
PDA TR 54-5Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing SystemsReport / Survey by Parenteral Drug Association, 05/01/2017
$195.00 $325.00 -40%Reduced price!In stockPDA TR 82
PDA TR 82Technical Report No. 82 (TR 82) Low Endotoxin RecoveryReport / Survey by Parenteral Drug Association, 2019
$195.00 $325.00 -40%Reduced price!In stockPDA TR 83
PDA TR 83Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and ResponseReport / Survey by Parenteral Drug Association, 2019
$195.00 $325.00 -40%Reduced price!In stockPDA TR 79
PDA TR 79Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect ParenteralsReport / Survey by Parenteral Drug Association, 03/01/2018
$195.00 $325.00 -40%Reduced price!In stockPDA TR 80
PDA TR 80Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical LaboratoriesReport / Survey by Parenteral Drug Association, 08/01/2018
$195.00 $325.00 -40%Reduced price!In stockPDA TR 81
PDA TR 81Technical Report No. 81 (TR 81) Cell-Based Therapy Control StrategyReport / Survey by Parenteral Drug Association, 2019
$195.00 $325.00 -40%Reduced price!In stock
