By: Tony Cundell, Ph. D., Microbiological Consulting, LLC, Rye, New York
Introduction
My participation in PDA Task Forces publishing Technical Reports as both as a Chair and an active task force member goes back 20 years. Based on this involvement, I am writing this commentary on the strengths and weaknesses of this important PDA activity. I would hope that this will be viewed as constructive criticism resulting in the process, which is going from strength to strength providing state-of-the-industry guidance on important topics. What prompted me to write this commentary? A positive review of science journalist Helen Pearson’s 2026 book Beyond Belief: How Evidence Shows What Really Works1 in the 7 May 2026 issue of Science prompted me to download it on my Kindle to read it which inspired me to write my commentary.
Evidence-based decision making in medicine, education, law enforcement, economics, public policy, etc. have frequently shown that current practices may be plain wrong, not cost effective, or even damaging to the public good. Discredited decision-making mechanisms include eminence (authority)-based decisions, traditional practice, intuition, and conventional wisdom. In terms of many guidance documents including PDA Technical Reports, FDA Guidance for Industry and USP Informational chapters, which are narrative reviews giving a written account of the evidence from selected literature may sometimes reflect the opinions and biases of the persons writing a section of the report or dominated by the chairs of the writing committee. Clearly, this should be avoided and can be countered by strong management, use of evidence-based information, and good document review procedures.
In the past 75 years, evidence-based decision making has become the gold standard in medicine. Randomized double-blinded clinical trials comparing the effect of treatment versus a placebo or current therapy on a similar patient population have been shown to be superior to observational and controlled cohort studies. One of the results of this movement are the publications of the Cochrane Collaboration that summarizes best practices in clinical management. On a personal note, I benefited from the use of the antibiotic Streptomycin, proven to be efficacious by 1948 clinical trial sponsored by the UK National Health Service, when I was hospitalized for pulmonary tuberculosis in my first year at university, 60 years ago. Other evidence-based decision tools applicable to the writing of technical documents are the systematic review of the curated literature using scientific-based search engines, e.g. Medline (U.S. National Library of Medicine), and meta-analysis of the obtained literature, which combines data from hundreds of studies of different size and quality to get a more definitive result. The selection of key words for literature searches is critical, and results of each search must be critically reviewed. These tools should be more widely used in the pharmaceutical industry.
A classic example of evidence-based decision making is the dramatic reduction in sudden infant death syndrome (SIDS) in newborn babies. Parents of baby boomers read Dr. Benjamin Spock’s best-selling 1946 book Baby and Child Care2 that contained an eminence (authority)-based recommendation to place baby face down when sleeping in a crib resulting in a peak U.S. SIDS rate of 130 deaths per 100,000 in 1990 to a reduced 36 per 100,000 in 2020 after the 1992 Back to Sleep campaign.3 Controlled cohort studies revealed that lying infants back down while sleeping significantly reduced SIDS, which was every parents’ nightmare.
Although the hierarchy of evidence from expert opinion to control random clinical trials is well established in medicine, the equivalent hierarchy of evidence on the product development, manufacturing process and product safety and efficacy is not adequately defined and routinely applied in the pharmaceutical industry. This could be a future challenge but constructing Quality Matrices of critical process and product attributes4 and investigating and correcting for any short-term deviation from the historic trends would be the place to start. The construction of an Ishikawa or fish-bone diagram of the manufacturing or testing process would be helpful to obtain a comprehensive understanding of all the inputs to the process and design experiments to justify evidence-based decision to make changes to your operation. Other tools that could be used are Quality-By-Design, Process Analytical Control, and Quality Risk Management.
PDA Technical Reports
Does the publication of Technical Reports match the PDA mission statement? I believe so. The stated PDA strategic objective is to advance its long-term mission to maximize product quality, availability, and value by connecting people, science, and regulation within the bio/pharmaceutical community. The question can be asked is the PDA a trade or technical organization? Does the PDA allocate their resources to best meet the expectations of their members? The PDA is designated as a 501(c)6 not-for-profit organization which includes business leagues, chambers of commerce, real estate boards, etc., created for the improvement of business conditions. This looks more like a trade organization. Based on an internet search, their 2024 revenue was reported as $15.3M with $12.7M from programs, with $553K net inventory sales which included publications, expenses of $15.6M giving a net income of -$330K while their net assets are $5.8M. Clearly technical conferences generate much more revenue than publications like technical reports, which may have more lasting value to our industry than a conference. However, the PDA could have a greater level of transparency so we can determine how their resources are applied. The latest budget of the organization should be published on their website whereas the last Annual Report issued was from 2020. This results in a less informed membership.
Since the publication of the Technical Report No. 1 Validation of Moist Heat Sterilization Cycles, first published in 1978, the growth of the catalog of technical reports has been impressive. The Current Catalog of Technical Reports contains Technical Reports – 76; Technical Guides – 1; Points to Consider – 15; and ANSI/PDA Standards – 6. The number of Technical Reports generated annually (new reports and revisions) averages four per annum for the past 10 years. The record shows that time to generate a Technical Report may range from one to five years, which represents a huge collective achievement.
This author suggests that the PDA membership should consider adding another tool beyond the Technical Report. For example, the approach taken in the Cochrane Reviews that summarizes and updates the best practices in medical care, which are evidence based, using systematic review and meta-analysis, could be adopted to recommend best practices in product development, manufacturing, testing, and regulatory compliance for the pharmaceutical industry. In keeping with the advances in information management, Artificial Intelligence/Large Language Model tools could be used to write and regularly update these best practices. Benchmarking by the author has found that big pharma companies are now encouraging their staff to use these tools. It is notable that physicians found, soon after it was released, that ChatGPT could provide satisfactory answers to clinical questions, which may be usable especially with a human in the loop (Johnson et al, 2023). It is recommended that this approach be subject to a pilot study for the generation of Technical Reports.
USP General Informational Chapters
This commentary applies to USP informational chapters. These chapters, numbered >1000, differ from general test chapters, numbered < 1000, which describe official test methods linked to specifications in product and ingredient monographs. In my experience as a long-time member of the USP Microbiology Expert Committee, these informational chapters are best written with recommendations from an Expert Panel with broader membership than found in an expert committee, e.g., USP <1071> Rapid microbial tests for release of sterile short-life products: a risk-based approach or written jointly with other expert committees such as the Packaging Expert Committee, e.g., <1207> Package integrity evaluation—sterile products. Also, the organization of open stakeholder conferences directed to consensus building around the revision of specific USP chapters is a useful tool
FDA Guidance for Industry
It is well recognized that role of these documents is to provide guidance on how the industry can comply with Good Manufacturing Practices, so they heavily reference the GMP regulations and other Guidance for Industry. They would be strengthened if they cited PDA Technical Reports and the key technical literature to support the positions taken. Again, these documents should be evidence based, using tools like systematic review and meta-analysis.
Organization of Task Forces for the Publication of Technical Reports.
A critical decision is the selection of chairs for the PDA task forces. Proposals received from individual members are encouraged and reviewed. The chairs are selected by the Director, Technical Services with input from the Science and Regulatory Affairs and Quality Advisory Boards, the Board of Directors and the PDA professional management. Recently there has been a preference for one co-chair from the United States and the other from Europe. As the meetings are virtual, the time differences re-enforce this pattern of membership with American participants calling-in in their morning and Europeans calling-in during their afternoon. For these reasons, participation from the Asia-Pacific region is underrepresented. The consensus building skills of the chairs should be emphasized more than their geographic location.
Membership in the task force are selected from volunteers by the Chair(s) based on expertise, diversity of companies, and geographic regions and PDA management recommendations. Other considerations are the age and level of education and experience of the members. A terminal research degree may enhance analytical skills and an interest and ability to evaluate the literature of a task force member. The related PDA Interest Group (IG) may be a logical source of recruits for the position of Chair and individual members, depending on how active the IG is and the quality of their membership. The role of the Chairs is to provide leadership, maintain motivation and focus, and completing the project more than providing content to the report. Specialists may be brought in areas like regulatory affairs, statistics, analytical chemistry, microbiology or process engineering to strengthen the technical report in these areas.
More attention should be given to the optimal size of the task force, as many are too large to effectively be managed virtually. Also, attention should be given to the frequency of meetings, use of sub teams for writing different sections, and mechanism of reaching a consensus as to the content. Research in the social sciences suggest that ideal size for an effective committee is generally between five and nine members.7 This sweet spot allows for a diverse range of perspectives while remaining small enough to make quick decisions, prevent “social loafing” (where members coast), and avoid scheduling stalemates. The PDA typically, to encourage participation in the organization, recruits too many members for committees. The addition of PDA project managers to each task force has been beneficial. Also, the number of pages in a typical technical report may be viewed as excessive. For example, the original 2000 Technical Report No. 33 Evaluation, validation and implementation of alternative microbiological methods was 38 pages, the 2013 revision 60 pages, and the 2026 revision is projected to be around 200 pages. This could be viewed negatively as technical report bloat. More concise documents have more impact and are more likely to be read and understood.
Managing conflict of interest and confidentiality is very important to the integrity of the technical reports. These standards should be clearly understood and enforced by PDA management.
Participation of regulators in the task force may be considered an advantage, especially if the objective is to develop positions more acceptable to regulators, in contrast to a state-of-the-art document. Often it is difficult to determine if a regulator on a task force is expressing their opinion or the policy of the regulatory agency. Fundamental conflicts between the emphasis on science, compliance with GMP regulations, and the interests of commercial suppliers of processing equipment and instrumentation to our industry, which is apparent to me in the wider PDA organization, can, but rarely, spillover into task force decision making.
Ensuring evidence-based content in the technical report is extremely important. Conventional wisdom, including regulatory expectations, may be wrong. As a microbiologist I could provide many examples of myths but that is a different article. For instance, are out-of-specification investigations effective, does increasing the intensity of environmental monitoring increase the sterility assurance of our sterile products or not, can a microbial count of a bulk drug product exceeding 10 CFU/100 mL add to the endotoxin content of a sterile product, etc.? Companies conduct studies and issue internal reports that are usually not published so they cannot be accessed as are studies reported in the published literature. Task force member may obtain permission to provide these reports to the Task Force and even include findings in the Technical Report. PDA-sponsored surveys of the membership may be useful in determining the state of the industry and establish best practices. Recommendations should be supported by the technical literature with key articles cited. Furthermore, this norm is not followed in many FDA Guidance for Industry and USP informational chapters.
Additional Challenges
Support from project managers, the technical editor and documentation tool centered on the platform Teams is helpful. PDA staff contributions with access to search engines to locate the literature, Artificial Intelligence assistance with editing, technical editorial assistance and supplying of copies of documents would be a welcomed addition.
Selection of experts for peer review, review by the PDA Scientific and Regulatory Advisory Board may be challenging generating hundreds of comments, many of them editorial. The Chair must respond to all comments in writing and make corrections to the Technical Report, when necessary. This is a significant challenge to both the review committee and task force members. Unlike documents generated by the FDA and the USP, which are published and open to broad stakeholder comment, PDA technical reports are only reviewed internally.
Free electronic copies of PDA technical reports are available to the membership for 30 days to reward membership. Subsequent sales are to members and non-members, at a higher price, to cover costs.
Members have questioned whether the contribution of technical report sales to the PDA budget is promoting the unnecessary revision of existing technical reports as advances in the pharmaceutical industry are slow. However, the proportion of revisions to new technical reports is 18%, which does not seem excessive and is necessary to update 78 technical reports.
Conclusions
PDA Technical Reports have a critical role in advancing the state-of-the-art in the pharmaceutical industry. Busy PDA members take time out of their schedules and even use their leisure time to participate in the writing and review technical reports while the PDA staff have contributed considerable resources to the improvement of the process. However, additional opportunities are available for improvements. Conflict of interest, especially for members acting as chairs of task forces, should be more tightly monitored and enforced and the overall numbers of task force members reduced with specialists added, if necessary. Finally, a more evidence-based approach to technical report writing would be beneficial.
References
- Helen Pearson’s 2026 book Beyond Belief: How Evidence Shows What Really Works Princeton University Press 368 pp 2026
- Benjamin Spock’s best-selling 1946 book Baby and Child Care
- CDC Report Trends in SUID Rates by Cause of Death, 1990—2022 https://www.cdc.gov/sudden-infant-death/data-research/data/sids-deaths-by-cause.html downloaded May 20 2026
- FDA Draft Guidance for Industry Submission of Quality Metrics Data. November 2016 https://www.fda.gov/media/93012/download May 20 2026
- PDA Technical Report No. 33 Evaluation, validation and implementation of alternative microbiological methods pp39 2000
- Johnson, D. et al 2023 Assessing the Accuracy and Reliability of AI-Generated Medical Responses: An Evaluation of the Chat-GPT Model Research Square https://doi.org/10.21203/rs.3.rs-2566942/v1
- Effective Committees: The Basics. American Library Association, September 11, 2009 https://www.ala.org/yalsa/aboutyalsa/yalsahandbook/effectivecommittees
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