Parenteral Drug Association

The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients. Standards from SAE are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: [email protected] or 1-212-642-4980 or Request Proposal Price.

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PDA PAC-2021

2021 Post-Approval Change Issues and Impacts Survey

Every pharmaceutical and biopharmaceutical product undergoes manufacturing changes after its initial approval by regulatory authorities. PDA sought the input of experts about the most significant post-approval change issues faced by manufacturers of drug products and/or active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making changes to products after the initial regulatory approval, regulators and industry together can develop effective solutions and prioritize the issues with greatest impact on global operations.   The survey was targeted at individuals who work for a company that manufactures finished products for human use (whether small molecule, advanced therapy, biologic, vaccine, or other) or APIs, and who have insights into both the types of post-approval changes that affect manufacturing and the impact those changes have on manufacturing operations.   This survey is a follow-on to 2016 PDA survey, the results of which were published in the PDA Journal. (1) This document includes certain results from that earlier survey that help illuminate or expand the discussion.

PDA TR 35-2001

A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry

This Technical Report is to develop an industry vision and guidance for instituting a step-wise, competency-based training program for microbiological training of individuals engaged in work activities connected to contamination control and microbiological testing of pharmaceutical articles.

PDA TR 64-2013

Active Temperature-Controlled Systems: Qualification Guidance

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 data. The temperature within a temperature-controlled vehicle; temperature-controlled ocean container; active unit load device (ULD); or walk-in, temperature-controlled stores (e.g., a cold room, refrigerator, freezer, or standalone unit) is expected to be maintained: Reliably and consistently through the period in which the product is stored within the controlled environment (i.e., over time); In compliance with the product requirements for temperature at all locations in which the product might be stored (i.e., temperature and location or storage boundary)

PDA TR 50-2010

Alternative Methods for Mycoplasma Testing

Using alternative methodology for the detection of mycoplasma requires validation and demonstration of comparability to reference standards. A PDA Task Force of experts has developed PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. The report focuses on non-culture testing methodology, including Nucleic Acid Amplification Technique (NAT) assays and enzyme activity based assays. Representatives of the U.S. FDA and the U.S. Pharmacopeia contributed to the report.

PDA TR 57-2012

Analytical Method Validation and Transfer for Biotechnology Products

This technical report is to provide practical and strategic guidance to efficiently use historical data and knowledge to design suitable risk-based AMV studies, and set appropriate protocol acceptance criteria.a

PDA TR 56-2012 (R2016)

Application of Phase-Appropriate: Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)

The scope of this technical report covers phase-appropriate Current Good Manufacturing Practices (CGMP) during the manufacturing of therapeutic protein drug substance (biological active substance) from the R&D stage through completion of Phase 3 clinical trials. The scope also includes implementation of a pharmaceutical quality system that ensures the safety and quality of products intended for use in clinical trials. Finally, it provides the basis for subsequent assurance of the equivalence of products used in trials to products submitted for marketing approval. This report will focus on current best practices.

PDA TR 69-2015

Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

A comprehensive program of bioburden management includes strategies for preventing and controlling biofilms and is based on current scientific knowledge of microbial growth and adaptation. This technical report 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 systems. The scope of the report encompasses pharmaceutical and biopharmaceutical manufacturing processes but does not include final aseptic and terminal sterilization fill-finish operations. It is important to educate engineers, scientists and managers about the science of bioburden and biofilms because of the broad and complex challenge of bioburden management.

PDA TR 51-2010

Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use

This Technical Report provides a comprehensive review of an area not adequately addressed in current guidance documents: recommended specifications for BIs to be used with sporicidal gas and vapor-phase decontamination cycles together with guidance regarding their manufacture, quality control, and use. The principles described in this report are based upon the manufacture and use of BIs prepared from spore suspensions; however, they can be equally applied to the preparation of BIs from other sources.

PDA TR 81-2019

Cell-Based Therapy Control Strategy

This technical paper aims to provide an overview of the approaches and tools available to support the design of a control strategy, considering the current regulatory framework and guidelines and proposing a pragmatic guidance applicable to cell and gene therapy. It highlights an approach for development of early-stage CGTP based on established concepts and describes how this approach can be used to ensure that the control strategy can be successfully managed as the product evolves. To illustrate how specific QbD elements can be applied, this technical report discusses the use of target product profiles, quality target product profiles, critical quality attributes, material attributes, and critical process parameters. It also indicates which risk management tools can be used to identify the attributes related to the product and process, as well as demonstrate the relationships that links the product profile to quality attributes and product attributes to material attributes and process parameters. Potential mitigation strategies are proposed for risks related to process or product and the design of a manufacturing control strategy for a product in early-phase clinical development is illustrated. T he content of this technical report applies to autologous and allogeneic cell therapy applications, including cells with ex vivo genetic modification. Though some concepts may be applicable to their development, gene therapy vectors for in vivo dosing are not within the scope of this report, however. As the focus of this report is early-stage development and due to the complexity of cell and gene therapy products, such topics as design space, process analytical technology, continuous/ongoing process verification, and process robustness are not addressed.