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PDA’s newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as …

PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers …

PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters describes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma …

This technical report provides guidance in the design, development, controls, procedures, validation, regulatory submission and implementation of reprocessing procedures for biopharmaceutical manufacturing. It focuses on recombinant biopharmaceutical products, including proteins and polypeptides produced …

PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.Over the past decade, a large number of subcutaneously injected biotechnology drug products …

PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance discusses the qualification and operational handling of passive thermal protection systems (TPS) for temperature-controlled distribution of pharmaceutical and biological …

Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products and their production processes. It also details new methods that have emerged as a result of technological …

PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified …

PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling …

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish …

The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is to provide detailed examples of characteristic operations and case studies that demonstrate the value of implementing QRM to effectively manage risks during manufacturing of biotechnological bulk drug …

The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products.This document is …

PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy …

Over the years, PDA expert task forces have developed several technical reports on moist and dry heat sterilization processes. In addition, experts in the PDA community of published several articles on these topics and alternative sterilization methods in the PDA Journal of Pharmaceutical Science and …

Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical …

Intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide …

Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability …

A recent benchmarking exercise conducted by the PDA Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials Technical Report Team indicates that extemporaneous preparation (EP) techniques are widely used to prepare a variety of formulations for a variety of dosage forms for …

PDA has revised Technical Report No. 3, originally issued in 1981. The revision offers a modern, scientific approach to dry-heat depyrogenation and sterilization processes and includes recommendations for use by industry and regulators. References to appropriate and current scientific publications, international …

The purpose of this technical report 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. This technical report has value for hospital and formulation pharmacies where manual …