Yejin Lee
Global Regulatory Affairs Manager, Biogen, USA
Introduction
When a new regulation or inspection trend appears, quality professionals usually ask the same question: what does good practice look like in detail? Regulations set expectations, but they rarely explain how to meet them. Much of that practical detail comes from industry bodies, and the Parenteral Drug Association (PDA) is one of the most widely used sources in sterile and biologics manufacturing.
PDA Technical Reports (TRs) are consensus documents written by volunteer teams from industry and often reviewed with input from regulators. They are not laws or regulatory guidance, but inspectors, auditors, and manufacturers around the world refer to them. A site that follows a current TR can usually explain and defend its approach far more easily.
PDA has been busy. Several long-standing reports were revised in 2026, new PDA/ANSI standards were published, and a group of newer Points to Consider documents addresses sterile and advanced therapy manufacturing. This article summarises the main updates, explains why they matter, and suggests practical steps for getting value from them.
A note on scope: the summaries below come from PDA’s own publication pages and press releases. I have not reproduced the reports themselves, so please read the full documents, available through the PDA Bookstore, before changing any procedure.
Understanding PDA Documents: What Type Is It?
PDA publishes several kinds of documents, and knowing the difference helps you judge how much weight to give each one.
- Technical Reports (TRs) are detailed, consensus-based guides on a specific topic, such as process validation or sterilisation. They are the best-known PDA product.
- Points to Consider (PtCs) present the authors’ thinking on emerging or unsettled topics. They invite discussion and are more flexible than TRs. PDA states clearly that these documents do not represent standards or regulatory guidance.
- PDA/ANSI Standards are formal American National Standards developed through an accredited consensus process. PDA has been an ANSI-accredited standards developing organisation since 2017, and approval as an American National Standard means the document meets ANSI’s requirements for openness, balance, and due process.
A TR or PtC is guidance, not a requirement. You are free to use another approach if you can justify it scientifically. In practice, though, departing from a widely recognised TR means you should be ready to explain why.
PDA members can download new Technical Reports within 30 days of publication as a member benefit, and anyone can buy them from the PDA Bookstore.
Revised Technical Reports in 2026
TR 56 (Revised 2026): Phase-Appropriate Quality Systems and GMP for Biological Drug Substance Development
TR 56 has been a global guide to best practices for developing biological drug substance since 2012, and its revision was published in early 2026. The revised report advises on what should be done to reduce the risk of delays, failures, and GMP non-compliance during product development, method development, and scale-up from phase 1 through phase 3 and validation, including practices to put in place before GMP manufacturing begins. Parenteral Drug AssociationParenteral Drug Association
PDA’s announcement describes it as a GMP-compliant, phase-appropriate quality management system spanning preclinical development through clinical phases and commercial readiness. It also notes that the report promotes science- and risk-based decision-making, helping organisations plan and run development programmes that are efficient and compliant. PRWebPRWeb
Why it matters. The central idea of phase-appropriate GMP is that quality expectations grow with the development stage. Early on, the priority is patient safety and data reliability; later, controls and documentation become more formal. Getting that balance wrong causes real problems. Systems that are too light cause trouble at inspection or during scale-up, while systems that are too heavy slow down small biotech teams. This revision is most relevant to:
- Biotech companies preparing for first-in-human manufacturing
- Sponsors working with contract development and manufacturing organisations (CDMOs)
- Quality teams building a quality system that has to scale
TR 60 (Revised 2026): Process Validation: A Lifecycle Approach
PDA’s bookstore lists the revised TR 60 as published in March 2026, and PDA announced it publicly on May 1, 2026. It is described as a useful reference for the industry’s continued focus on process validation, manufacturing reliability, and product quality, and it defines process validation as collecting and evaluating data that establishes scientific evidence that a process can consistently deliver quality product. The press release states that the report provides updated guidance supporting a lifecycle approach to process validation that aligns with current regulatory expectations. Parenteral Drug AssociationPRWeb
Why it matters. The lifecycle concept behind TR 60 follows the model used in the FDA’s 2011 process validation guidance and in EU GMP Annex 15: process design, process qualification, and continued process verification. Many companies still treat validation as three batches and a report. The lifecycle view instead asks whether you understand the process, whether the validated state is maintained, and whether you detect drift before it becomes a failure.
Practical points to consider when reading the revision:
- Process design. Do your development data justify the critical process parameters and the control strategy?
- Qualification. Is the number of batches and the sampling plan based on risk and variability, not habit?
- Continued process verification. Do you trend data after launch, and does anything trigger action?
- Alignment. Do your validation master plan and procedures reflect lifecycle language and current terminology?
TR 74 (Revised 2026): Reprocessing and Reworking of Biologicals
The revised TR 74 was released together with TR 60. It gives guidance on the design, development, controls, procedures, validation, regulatory submission, and implementation of reprocessing and reworking procedures for biologicals, balancing scientific, regulatory, and business considerations. It focuses on reprocessing of biologicals but can also apply to reworking in general. Parenteral Drug Association
Why it matters. Reprocessing and reworking are sensitive topics. Done well, they can rescue a batch without harming product quality. Done poorly, they may hide process weakness or raise data integrity concerns. Some key questions any site should ask:
- Is the reprocessing step defined, validated, and, where needed, registered with the regulator before it is used?
- Does it affect product quality attributes, such as aggregation, potency, or impurity profile?
- How are reprocessed batches tracked and trended?
- Is reprocessing part of the plan, or an informal fix for a recurring problem?
A revised TR does not change the regulatory rule that unplanned reprocessing needs a documented deviation and quality approval. It does give a structured way to think about prospective, controlled reprocessing.
TR 14 (Revised 2026): Validation of Column-Based Chromatography Processes for the Purification of Proteins
The newest of the group, TR 14, appeared on the PDA Bookstore in September 2026. The revision reflects best practices in column-based chromatography validation and follows a lifecycle validation approach using risk-based tools. PDA states that validation should provide a high degree of confidence that the process performs consistently, removing process- and product-related impurities and viruses when executed as designed. Premium members have until October 10, 2026 to claim their free copy. Parenteral Drug AssociationParenteral Drug Association
Why it matters. Chromatography steps are at the heart of downstream purification for monoclonal antibodies and other proteins. They are responsible for clearing host cell proteins, DNA, aggregates, and viruses. Areas where the revision is likely to influence practice include:
- Resin lifetime studies and cleaning and sanitisation effectiveness
- Carryover between cycles and across campaigns
- Column packing qualification and performance monitoring
- Linking small-scale models to commercial scale
- Use of risk assessment to decide what to test and how often
If your company is moving from one-off validation studies toward lifecycle management of purification steps, this report is a timely reference.
New PDA/ANSI Standards
PDA has also been expanding its portfolio of formal standards. Two new ones were published in 2026.
PDA/ANSI Standard 07-2026: Analytical Procedure Transfer, Comparability, and the Use of Platform Analytical Procedures for Biologics
According to PDA’s announcement, this standard provides best practices for designing scientifically rigorous approaches to analytical procedure activities for biologics. During development it was listed under the working title Analytical Procedure Replacement, Transfer and the Use of Analytical Platform Procedures for Biologics. LinkedIn
Why it matters. Analytical methods change during a product’s life. Laboratories are replaced, technologies get upgraded, and methods move between sites. Each change raises a question: does the new procedure give results comparable to the old one? Platform procedures, which use the same method with minimal adjustment across similar products such as monoclonal antibodies, can speed up development but need clear justification. This standard is useful for QC and analytical development teams, and it complements the wider analytical lifecycle thinking in ICH Q2(R2) and Q14.
PDA/ANSI Standard 08-2026: Apheresis Collection for Cell and Gene Therapy Products
This American National Standard provides guidance to harmonise recommendations for apheresis material collected for further manufacturing of cell and gene therapy products. The starting material for many autologous and allogeneic therapies is collected from a donor or patient, and variability at this point can strongly influence everything that follows. LinkedIn
Why it matters. Collection practices differ between clinical sites, and inconsistent starting material can affect manufacturing success and product quality. A harmonised reference helps manufacturers, collection centres, and regulators speak the same language.
Recent earlier standards worth noting
Two standards from 2025 remain relevant to sterile manufacturing and quality systems:
- PDA/ANSI Standard 03-2025 covers a lifecycle approach using a holistic evaluation of contamination control systems designed to minimise or prevent contamination during aseptic processing. It fits closely with the Contamination Control Strategy expected under EU GMP Annex 1 (2022). SQA Services
- PDA/ANSI Standard 06-2025 covers five key focus topics with attributes, characteristics, and measurements for establishing, measuring, and maintaining a mature quality culture within a quality management system. SQA Services
Points to Consider: Sterile and Advanced Therapy Manufacturing
Points to Consider No. 12: Restricted Access Barrier Systems (2025)
Released in June 2025, this document addresses the ongoing confusion surrounding regulatory expectations for restricted access barrier systems (RABS) in sterile pharmaceutical manufacturing, offering guidance on interpreting and applying current regulations including EU GMP Annex 1 and FDA requirements. Its topic list includes RABS design, the physical environment, personnel, glove integrity testing and maintenance, environmental monitoring, and material transport and loading. Like other PtCs, it does not represent a standard or regulatory guidance. Just Released: Points To Consider No. 12: Restricted Access Barrier Systems | PDA +2
Why it matters. Annex 1 pushes the industry toward barrier technology and away from direct human intervention in critical zones. Gloves, interventions, and decontamination remain frequent sources of inspection findings, so practical advice on RABS design and operation is valuable to any aseptic filling operation.
Other recent Points to Consider
PDA’s technical report portal lists additional recent documents, including:
- PtC No. 13: Materials in ATMP Manufacturing
- PtC No. 14: Manufacturing of ATMPs, Facility Design (Part 1)
- PtC No. 15: Mobile Manufacturing
- TR 22 (Rev. 2025): the revised report on process simulation for aseptically filled products, also known as media fills
Together, these show a clear direction. PDA is paying close attention to advanced therapy medicinal products (ATMPs), decentralised and mobile manufacturing, and ongoing alignment with Annex 1. Media fills, in particular, are a routine focus of sterile inspections, so anyone running them should look at the revised TR 22.
What These Updates Mean for Your Organisation
Reading every new document in full is not realistic for most teams. A structured approach helps.
Step 1: Map the updates to your scope
Identify which documents relate to your products and processes. A sterile fill-finish site will care most about PtC 12 and TR 22. A biologics developer will look at TR 56, TR 14, and TR 74. A QC laboratory supporting biologics will prioritise PDA/ANSI 07-2026.
Step 2: Perform a gap assessment
Compare your current procedures and practices with the recommendations. Record each difference as one of three outcomes:
- Aligned: nothing to do.
- Different but justified: document the rationale, for example a risk assessment.
- Gap: plan a corrective action under change control.
Step 3: Prioritise by risk
Not every gap deserves the same urgency. Focus first on anything that affects patient safety, sterility assurance, or data reliability. Lower-risk improvements can be scheduled into routine procedure revisions.
Step 4: Update documents and train
Amend validation master plans, SOPs, and templates where necessary, and train staff on the changes. Training should explain the reasoning as well as the new steps.
Step 5: Keep a record of your decisions
Inspectors rarely ask whether you own a particular TR. They ask how you decide what good practice is and whether you follow your own rules. A brief record showing that you reviewed new industry guidance and made a reasoned decision is strong evidence of a mature quality system.
Common Mistakes When Using PDA Reports
- Treating a TR as a legal requirement. It is guidance. Adopt what fits your process and justify differences.
- Cherry-picking. Using only the parts that support an existing practice weakens your position.
- Ignoring the date. Guidance evolves. Check you are using the current revision, especially when a report has been replaced.
- Copying without understanding. Numbers and examples in a TR come from the authors’ experience. Your process may need different values, supported by your own data.
- Forgetting the regulators. TRs support, but do not replace, the primary sources: GMP regulations, ICH guidelines, and pharmacopoeial chapters.
Looking Ahead
Several themes stand out from PDA’s recent output:
- Lifecycle thinking is now the default in validation, from process validation (TR 60) to chromatography (TR 14) and analytical procedures (ICH Q14 and PDA/ANSI 07-2026).
- Contamination control continues to grow in importance, driven by Annex 1 and reflected in PDA/ANSI 03-2025, PtC 12, and TR 22.
- Advanced therapies are receiving dedicated attention, with standards and Points to Consider covering apheresis, materials, facility design, and mobile manufacturing.
- Quality culture and risk management are treated as core system elements, not add-ons.
- Phase-appropriate approaches help small and early-stage companies apply GMP intelligently, as TR 56 shows.
The pace of publication suggests more revisions are likely. PDA’s publication pages and press releases are the most reliable place to check for new releases.
Conclusion
PDA’s 2026 publications show where industry practice is heading. The revised TR 56, TR 60, TR 74, and TR 14 reinforce a risk-based, lifecycle approach across development, validation, reprocessing, and purification. The new PDA/ANSI standards address analytical comparability and cell and gene therapy starting materials, and earlier documents on RABS, aseptic risk management, and quality culture remain directly relevant to sterile manufacturers.
For quality and regulatory professionals, the goal is not to collect documents but to use them well: decide which ones apply, compare them honestly with current practice, close the important gaps, and document the reasoning. Teams that do this keep their systems aligned with current expectations, and they can explain their choices confidently to an inspector, an auditor, or a colleague.
Guideline References
- PDA. Technical Report No. 56 (Revised 2026): Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance. Parenteral Drug Association, 2026.
- PDA. Technical Report No. 60 (Revised 2026): Process Validation: A Lifecycle Approach. Parenteral Drug Association, 2026.
- PDA. Technical Report No. 74 (Revised 2026): Reprocessing and Reworking of Biologicals. Parenteral Drug Association, 2026.
- PDA. Technical Report No. 14 (Revised 2026): Validation of Column-Based Chromatography Processes for the Purification of Proteins. Parenteral Drug Association, September 2026.
- PDA. Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products. Parenteral Drug Association, 2025.
- PDA/ANSI. Standard 07-2026: Analytical Procedure Transfer, Comparability, and the Use of Platform Analytical Procedures for Biologics. 2026.
- PDA/ANSI. Standard 08-2026: Apheresis Collection for Cell and Gene Therapy Products. 2026.
- PDA/ANSI. Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes. 2025.
- PDA/ANSI. Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools. 2025.
- PDA. Points to Consider No. 12: Restricted Access Barrier Systems. 2025; Points to Consider Nos. 13–15 (ATMP materials, ATMP facility design Part 1, and mobile manufacturing).
- European Commission. EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. 2022.
- European Commission. EudraLex Volume 4, Annex 15: Qualification and Validation.
- U.S. FDA. Guidance for Industry: Process Validation: General Principles and Practices. January 2011.
- ICH. Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development. 2023.
- ICH. Q9(R1) Quality Risk Management and Q10 Pharmaceutical Quality System.