Interest Groups

This interest group is focused on the unique challenges faced in the development and commercialization of cell and gene therapy products. The need for collaboration is essential, given the nature of these products, the evolving science, and the need for clarity in the application of the GMPs. Considering the strongly academic base of knowledge for these products, PDA has a unique opportunity to provide collaborative guidance that will benefit the patient community as the participants steward their products toward commercialization. The group will share insights on: new, advanced manufacturing techniques, experimental approaches to address the challenges of lifecycle management, scientific thinking related to standards and standardization, and commercialization efforts of maturing companies within the space.

The Biopharmaceutical Manufacturing IG brings together industry leaders in facilities, manufacturing and process design to address the rapidly evolving field of biopharmaceuticals. The group covers topics including: continuous manufacturing, productivity improvements in manufacturing processes, new technologies for downstream purification, manufacturing control strategies, real-time and online testing, facility design and facility of the future considerations, and technology standardization.

The Biosimilars Interest group is focused on the development of best practices for emerging CMC challenges in the manufacture and control of Biosimilar products, including:

• Demonstration of biosimilarity to the originator product
• Development of specifications and process control for biosimilars
• Process validation approaches for rapid biosimilar development
• Demonstration of stability for rapid development programs

The newly re-formed Combination Products IG provides a forum for discussion of topical issues concerning technical, regulatory (submissions) and compliance matters related to combination product types with emphasis on drug delivery devices and functional pharmaceutical packaging.

The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The Interest Group has previously discussed regulatory issues, new technologies, and emerging industry trends. Recent issues include vaccine availability and supplies, homeland security, and inspection trends. The group also issues a newsletter (VIG). All PDA members are welcome to attend VIG meetings, which are held in conjunction with PDA events.

This interest group will be focused on Data Integrity, Management of the Data Lifecycle and the Codes of Conduct to ensure Data Integrity. As Data Integrity is a concern for regulatory agencies worldwide, the need for clarity in the application of Data Management and codes of conduct within the industry is essential to ensuring product quality and patient safety. This IG also supports the Data Integrity Task Force and will inform members on their publications and activities. IG members could participate in organizing a PDA conference, writing articles, or providing training.

The GMP Links to Pharmacovigilance Interest Group will facilitate the incorporation of medical expertise and oversight in the form of a clinical assessment of the potential safety issues with product performance and Quality System elements.  Quality attributes of a product, including product specifications, are linked to patient experiences and add value to fundamental quality activities. 

The focused elements for this Interest Group are as follows:

• Risk control linked to medical patient risk
• To link Quality System elements to Pharmacovigilances and Approved Risk Evaluation and Mitigation Strategies (REMS)
• To address link recalls, complaints and adverse effects
• The establishment of and deviation from Critical Quality Attributes (CQAs) and the link to the Quality Target Product Profile (QTPP)
• The link to Regulatory filing issues (e.g., label claims).

The mission is achieved by:

• An improved understanding of the clinical (patient experiences) and GMP Quality Systems (product specifications)
• Discussing case studies of positive and negative experiences in this venue
• Contributing to global regulations and guidance as appropriate
• Sponsoring plenary sessions, break-out sessions, and possibly a conference to bring together experts in this field.

This IG will discuss the latest challenges and opportunities in auditing, including the evolution of the audit process in the context of “GXP Auditing 4.0” and will provide an open forum to share and align on best practices, address challenges, and provide common solutions that benefit the whole industry.

Mission Statement

The Management on Outsourced Operations Interest Group will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities. 

Scope

• To monitor regulatory developments, guidances and standpoints regarding management of outsourced activities
• To support the preparation of position papers, Points to Consider documents, or a Technical Report on outsourcing as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
• To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9, and principles of Quality Risk Management in managing outsourced activities
• To provide input to scheduling and content of PDA conferences and TRI courses on outsourcing.

The Pharmacopeial Interest Group will serve as the liaison between RAQAB and the Pharmacopoeias, focusing mainly on the major pharmacopoeias of the world (e.g., USP, Ph. Eur., Japan Pharmacopeia, India Pharmacopeia, China Pharmacopeia, Brazil Pharmacopeia and the International Pharmacopeia (World Health Organization).  The deliverables of the group are as follows:

• To advocate globally for greater pharmacopeial cooperation, harmonization (both prospective and retrospective), working towards the ultimate goal of a single international publication
• To monitor compendial activities and publications and provide periodic reports to RAQAB
• To prepare science based position papers on compendial initiatives and proposals for approval
• To represent PDA at the Pharmacopeial Stakeholder Forums
• To proactively identify compendial topics.

The Quality Risk Management (QRM) Interest Group and its ConnectSM social media page is a place where you can post questions, seek answers, generate discussions and in general, interact with our peers. The mission of our QRM Interest Group is to learn, promote, share best practices within our interest group community that can help us incorporate and advance Quality Risk Management practices in our respective organizations. Your postings and discussions on this Web page will serve a critical function in not only building and advancing communications within this Interest Group, but can also help with our own QRM implementation journeys.

The PDA Quality Systems Interest Group is a network of QA/QC professionals. Past topics have dealt with diverse subjects ranging from Systems Based Inspections, to QA /QC Organizations, to Risk Analysis. The Quality Systems Interest Group also sponsors a Quality Systems Forum on the PDA Web site for daily networking opportunities. Members participate in Task Forces on Compliance and Quality related topics.

Mission Statement

The Regulatory Affairs Interest Group will provide a platform for sharing current information among PDA members on Regulatory Affairs (both US and International) to enable understanding and interpretation of the dynamic regulatory landscape. The Reg. Affairs IG will also serve as the liaison for Regulatory related communication/activities with PDA’s RAQAB.

Scope

• To monitor regulatory developments and guidances of interest to the PDA members
• To support the preparation of position papers, Points to Consider documents, or Technical Reports related to Regulatory Affairs, as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
• To provide input to scheduling and content of PDA conferences and IG meetings on Regulatory Affairs

Suppliers of raw and manufactured materials to biotech and pharmaceutical companies, as well as those drug manufacturers,  are challenged with an increasing complexity of the material supply chain.  This has in turn led to increasing difficulty in ensuring quality supply of materials and components, excipients, and APIs.  Furthermore, the integrity of the supply chain is being challenged by increasing sub-standard manufacturing, inadequate business and process controls, as well as international counterfeiting practices.

The Supply Chain Management Interest Group offers its members the opportunity to influence the suppliers of the pharmaceutical and biotech industry to develop requirements that meet the needs of the industry in the areas of material quality, continuous improvement efforts, supply chain security, and supplier/customer business partnerships.  The Interest Group will use existing information gathered from PDA members, suppliers, other industry groups, and drug manufacturers to document and develop best practices approach for suppliers to meet customer requirements globally.

This interest group has as its main objective to capture the opportunity given by the benchmarking of our experience in Technology Transfer projects; with potential opportunity like TR, articles, position papers, training sections, and lectures.

The group will discuss the technology transfer projects topics, from manufacturing process to analytical transfer, from equipment user requirements definition to process validation, from Contract Manufacturing Organization selection to Business Discontinuity, from appropriateness of the documentation to lesson learnt approach and statistical data analysis, without  never forget the ethic behind our job.

Pharmaceutical Technology Transfer Projects consist of planned and controlled actions that are based on well-defined acceptance criteria to convey a Pharma technology with all its attributes from a sending unit to a receiving unit and involve a complex group of internal and external stakeholders. Risks are hidden everywhere; it’s mandatory to have a robust and efficient methodology to identify, mitigate and control them.

For that reason we think a Technology Transfer Interest Group will help all of us find best practices, monitor worldwide trends, analyze clusters of peculiarities based on companies, countries, dosage forms, drug entities.

The Annex 1 Implementation Interest Group and its Connect^® social media page is a place where you can interact with industry peers, seek answers, generate discussions and in general keep up to date on the challenges and approaches being used related to Annex 1 Implementation.

The Applied Statistics Interest Group is concerned with the creation, development and manufacture of pharmaceutical products using statistical tools from starting materials to finished product; from development through manufacture and end of use—all along the lifecycle. Improving the understanding of issues for applied statistics within the scientific, technical and pharmaceutical community; providing an environment where our PDA membership has a resource to explore and understand tools being employed by experienced users. We encourage an internationally based membership in order to foster a harmonized vision of Applied Statistics.

The Facilities and Engineering Interest Group provides a forum for the discussion of topics and interests related to the design, construction, operation and maintenance of the production and research facilities used for GMP and GLP purposes. Discussions are held in conjunction with two of the PDA meetings: the Annual Meeting and the PDA/FDA Joint Conference, as well as a discussion forum on the PDA website.

The format of the Facilities and Engineering Interest Group meetings are an open forum for discussion, where attendees select the topic for discussion and the leader moderates the discussion of peers seeking to reach a better understanding of regulatory expectations and opportunities to share and learn best practices. Where appropriate, the Facilities and Engineering Interest Group will compile these understandings and best practices into technical reports with the contributions and review of interested members. 

The PDA Filtration Interest Group provides a forum for discussion of topics and issues related to filtration in pharmaceutical and biopharmaceutical applications, including sterilizing filtration of liquids and gases, depth filtration of process streams and process systems, and viral removal and purification. Discussions are held in conjunction with PDA meetings (e.g., the Annual Meeting and PDA/FDA Joint Conference) and via discussion forum on the PDA website.

Below is a very brief “white paper” dealing with sterilizing filter integrity test rinse volume developed by members of the Filtration IG.

As a constantly developing field there are always new perspectives in the science, technology and compliance realms. This interest group provides an open forum for discussions on current topics. Topics are identified at the onset of the meeting for open discussions among participants. This provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices.

For more information about the Lyophilization Technology Interest Group contact [email protected].

The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring, and compendial issues. The group typically has a guest speaker followed by a group discussion. If warranted, task forces are established to respond to issues relevant to microbiologists.

The Packaging Science Interest Group (PSIG) is a venue for the exchange of knowledge and ideas about pharmaceutical packaging. Members come together to develop presentations for PDA programs, organize special meetings on current topics, review USP and FDA proposals and regulations, work on task forces on focused topics, and educate each other. Meetings are held in conjunction with PDA meetings.

The Pharmaceutical Water Interest Group addresses topics in pharmaceutical water quality, analytical and microbiological control, rouging and biofilm concerns, continued water monitoring and compendial issues. The interest group shall provide for an on-going forum for the exchange and dissemination of information and ideas for the purpose of education, innovation, and compliance related to purified water science. In addition, the interest group shall foster scientific and technical activities through the development technical reports, journal articles, presentations and recommendations of other activities such as conferences or training courses on subject of water quality.

The Prefilled Syringe Interest Group provides a forum for discussions of actual topics related to prefillable injection system components such as cartridges or syringes and combinations thereof with injection and safety devices. Members come together to exchange in an open discussion latest information about technological improvements in the universe of prefillable syringes and injection devices, covering production, filling, handling and regulatory aspects. The format of the Interest Group meetings includes formal presentations of experts from industry and government as well as open discussion forums and preparation of upcoming conferences to related topics.

To provide an on-going forum for the exchange and dissemination of information and ideas for the purpose of education, innovation, and compliance related to the validation of critical processes and those activities which support the validation of critical processes.

The interest group should be a forum for presenting and discussing issues and trends in validation. These discussions should result in a better understanding of PDA member needs. This in turn results in better programs, more useful publications, and appropriate areas of advocacy.

This interest group shares knowledge, experience, and insights on aspects of sterile processing and parenteral drug manufacturing. Topics addressed include: cleaning and sterilization methods, practices, and validation, media fills, and more.

The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, recent regulatory activity and country specific inspection requirements. This group has also initiated activities to survey industry inspection practices, organize special meetings on visual inspection and to provide scientific guidance on compendial requirements for the inspection of injectable products.