The mission of the Development Technical Committee (DTC) is to promote scientific studies to engender science-based regulatory policy relating to the development of drugs and drug products, working with industry, academia, pharmacopeias and regulatory agencies.  DTC Working Groups (WGs) focus on research projects that help to more clearly define through technical examples and applications the Quality by Design (QbD) concepts.  For more information about the DTC, see the attached flyer.

Copies of DTC Minutes are available upon request.  Please contact the PQRI Secretariat for copies of minutes.

Reports and White Papers are available at Publications.

NEWS

The PQRI Parenteral and Ophthalmic Drug Product Leachables and Extractables (PODP L&E) Working Group has recently posted a brief update on its work to develop a risked–based approach for evaluation and safety qualification of leachables in PODPs.

To justify the use of safety thresholds for identification and risk assessment of PODP leachables, the group conducted and evaluated the results of extraction studies on polymeric materials and evaluated a database of over 600 potential leachables.

Based on their findings, the Working Group  has developed a set of best practices for parenteral drug products, which is summarized in this update and will be described in more detail in a forthcoming publication.

• Current Working Groups
  • Parenteral and Ophthalmic Drug Products (PODP) WG – Leachables in parenteral and ophthalmic drug products (PODP) are those compounds (both organic and inorganic) that are present in the drug product due to leaching from packaging systems (container closure systems, CCS) and/or their components or materials of construction that are in direct or indirect contact with the PODP.  The PODP WG is creating Best Practices and toxicological evaluation approaches for extractables and leachables in parenteral and ophthalmic drug products (PODP).  The PODP WG held a workshop on April 18-19, 2018.  Click here to access the presentations.
  • Stability Shelf Life WG – Investigating and developing improved statistical approaches for setting shelf life based on stability data.
• Emerging Projects
  • Development of White Paper on Vial Transfer Spikes
• Past Work Groups
  • Stability Shelf Life WG- The PQRI Stability Shelf Life Work Group published alternate statistical techniques for estimating shelf life.
  • Container/Closure Systems WG- Demonstrated that MVTR/Unit is a Critical Parameter in defining equivalence; definition of optimal parameters for bottles, low and high barrier films.  Standard WVTR Test Method ratified as D7709-11by ASTM D10.32; publication of draft Barrier Performance Determination Method in USP; USP/PQRI Workshop; publication of PF Stimuli Article Development and Application of MVTR/Unit Data in Regulatory Submissions.
  • Sulfonate Esters WG- Developed highly sensitive analytical test methods to detect sulfonic acid esters and used them to study targets in varying conditions.
  •  Excipients WG published survey and FDA concepts on Excipient Control Strategies; held a workshop on current industry and regulatory practices.
  • Leachables & Extractables in Orally Inhaled & Nasal Drug Products WG – Developed recommendations for the E&L in orally inhaled and anasal drug products, related training courses and scientific publications, including the book Leachables & Extractables Handbook:  Safety Evaluation, Quantification, and Best Practices Applied to Inhalation Drug Products.
  •  The RFID WG looked at implications of using radio-frequency identification devices on boxes containing pharmaceutical products.
  • The Aerodynamic Particle Size Distribution Mass Balance WG evaluated the suitability of specifications for mass balance obtained from cascade impactor measurements, as recommended in draft FDA guidances for orally inhaled and intranasal drug products.
  • The Aerodynamic Particle Size Distribution Profile Comparisons WG developed a robust statistical method for establishing in vitro bioequivalence of aerosol particle size distributions of orally inhaled and intranasal drug products.
  • The Impurities WG determined appropriate methods and extent of characterization for impurities as a function of the stage of product development.
  • The Physical Attributes/ Particle Size WG discussed test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.
  • The Specifications/ BACPAC WG considered a core set of specifications (test, analytical methods, and acceptance criteria) that would assure the identity, strength, quality, purity and potency of a drug substance following a manufacturing change after the final intermediate.