Publications
Technical Reports
PDA's New Technical Report Portal is Now Open!
Visit PDA's New Technical Report Portal
PDA MEMBERS ONLY: Welcome to Your Technical Report (TR) Portal
In this new portal, PDA members are able to view the complete library (or collection) of PDA Technical Reports (TR). PDA TRs are a highly valued membership benefit. They are global technical documents, prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia.
PDA Technical Reports are highly valued membership benefits. They are global technical documents, prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia. Current Technical Reports address a wide array of challenging technical areas, including use and validation of pharmaceutical filters, sterilization technologies, non-conformities in glass vials and ampoules, pharmaceutical microbiology, glass defects, process validation and good distribution practices, including cold chain, and quality risk management.
Every PDA members receives the opportunity to download new technical reports free of charge within 30 days of publication as part of their regular membership benefits.
Here is a short-list of the most recent Technical Reports:
PDA Technical Report No. 61 (TR 61), Steam In Place
The primary objective of the task force responsible for this technical report was to develop a scientific technical report on SIP processes that provides recommendations for use by industry and regulators. References to appropriate and up-to-date scientific publications, international regulatory documents, journal articles, technical papers, and books are used to provide more detail and supportive data can be found.
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PDA Technical Report No. 60 (TR 60), Process Validation: A Lifecycle Approach
PDA's newest technical report, Process Validation: A Lifecycle Approach, presents timely and real world guidance for the application of a lifecycle approach to process validation. The lifecycle approach has been the focus of recent process validation guidances from major regulatory agencies and represents a significant change in expectations in this area. It will review requirements for process validation studies across the three-stage approach defined by the FDA and also discuss best practices for integration with supporting Quality Systems.
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PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation
The 2012 revision of Technical Report 29 builds on the 1998 report and utilizes principles and specific wording from the 2010 PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation. It presents updated information that is aligned with lifecycle approaches to validation and the International Conference on Harmonisation (ICH) guidelines Q8 (R2) - Pharmaceutical Development, Q9 - Quality Risk Management and Q10 - Pharmaceutical Quality System.
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PDA Technical Report No. 59 (TR 59) Utilization of Statistical Methods for Production Monitoring
The purpose of PDA Technical Report No. 59 Utilization of Statistical Methods for Production Monitoring is to present relevant and easy to use Statistical Process Control Methods that are applicable to our industry. This Technical Report is the latest produced as part of PDA's Paradigm Change in Manufacturing Operations SM initiative.
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PDA Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution
This PDA Technical Report is meant to assist stakeholders in the supply chain to preserve the quality, safety and efficacy of these products during distribution. This guidance document serves to complement the information provided in ICH Q9 guideline (Quality Risk Management) and previously published PDA Technical Reports No. 39, 46, 52 and 53 by assessing, controlling and reviewing risks in systems and processes during distribution.
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PDA Technical Report No. 57: Analytical Method Validation and Transfer for Biotechnology Products
Similar to the manufacturing process, an analytical method can also be considered a process. The validation strategy for analytical methods could therefore conceptually follow those of Process Validation. As such, Analytical Method Validation (AMV) can be defined as the collection and evaluation of data from the analytical method development stage throughout routine QC testing which establishes scientific evidence that an analytical method is capable of consistently delivering accurate and reliable results.
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This PDA Technical Report covers phase-appropriate CGMPs 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.
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