Calling all nasal suspension and solution pharmaceutical product experts!On behalf of the PQRI’s Biopharmaceutics Technical Committee, we invite you and your colleagues to participate in a survey on Regulatory Challenges for Post-approval Changes of Nasal Suspension Solution Products.

The objective of this survey is to better understand the challenges of post-approval changes for nasal suspension and solution products when manufacturers of new drugs and generic products need to make changes in products after approvals of the applications. The results will be used by PQRI to identify topics for further discussion, research, and or potential workshops. The results will also be shared with FDA, which is a member of PQRI, for awareness of challenges with post-approval changes for nasal suspension and solution products.

Access the survey at this link.  Responses are requested by September 30, 2024

To preview the survey questions, please see this link to a PDF copy of the survey. Please DO NOT use the PDF to submit your response. Only online responses will be accepted.

If you have any questions about the administration, content, or applications of this survey, please contact PQRI’s Secretariat (Jillian.Brady@faegredrinker.com).

CURRENT EVENTS

March 20-21 2025

Registration to open in mid-January

FDA/PQRI Workshop: Exclusive Face-to-Face Workshop with Senior-Level
FDA Experts: ANDA Quality with CDER’s Office of Pharmaceutical Quality

Visit the Workshop webpage for more details.

 PQRI TiO2 Position Paper Available

The PQRI TiO2 Workshop Organizing Committee and workshop speakers prepared a PQRI position paper derived from the PQRI June 2023 TiO2 Workshop.  The position paper provides an overview of the significant information that was presented by the expert speakers who participated in the workshop as well as ideas that were discussed during breakout sessions held to obtain broad feedback from the workshop participants on several key points related to TiO2 safety and the challenges of using TiO2 alternatives in many drug applications.  The paper is available here.

PQRI Webinar:  PFAS Restrictions – What you Need to Know and the Potential Impact Across the Pharmaceutical Industry and the Supply Chain Continuum – Presentations and Recording Available – see below

PQRI held a very important webinar to discuss the potential impact the polyfluoroalkyl substances (PFAS) ban proposed by the European Chemicals Agency (ECHA) may have on the supply of pharmaceutical products and the patients who use those products.  This complimentary 90-minute webinar was held on August 8, 2023.   A PDF copy of the presentations is available here.  You can view the recording here.

PQRI Comments on ECHA’s Proposed PFAS Ban Across the Pharmaceutical Industry

PQRI launched a questionnaire to gather information on the impact of the polyfluoroalkyl substances (PFAS) ban proposed by the European Chemicals Agency (ECHA) on the supply of pharmaceutical products and the patients who use those products.

PQRI used this information to prepare a position paper that captures the scale of the impact of ECHA’s proposed PFAS restrictions across the pharmaceutical supply chain. The unique scientific challenges faced in replacing PFAS or PFAS-containing products cannot be fully understood without crucial evidence for use.  The position paper was submitted to ECHA on September 23, 2023.  A copy of the submission is available here. 

BACKGROUND 

On February 7, 2023, ECHA published the Annex XV Restriction Report, which proposes a PFAS ban aimed at significantly affecting the manufacture, marketing, and use of approximately 10,000 types of PFAS. These chemicals are categorized as polymers and non-polymers, which contain multiple classes and have various applications across a wide range of industries. Manufacturers and importers would no longer be able to supply downstream users with PFAS or PFAS-containing products once the proposed restriction comes into force.

As per Annex XV, the current proposed restriction provides two risk management options:

• • “no derogations and a transition period of 18 months”
  • “a full ban with use-specific time-limited derogations (18 month transition period plus either a five or 12 year derogation period” (with sufficiently strong evidence.)

There is an exception for unlimited derogations for active substances. There is insufficient evidence for derogations with respect to PFAS usage throughout the pharmaceutical supply chain. The ECHA proposal is expected to be finalized in 2024 and effective by 2027. As currently written, it would likely have a significant impact on patient access to lifesaving medicines.

NEWS

PQRI Strategic Plan 2023-2027: PQRI is pleased to announce the release of its 2023-2027 Strategic Plan. PQRI will continue to be a leading organization in creating best practices and conducting joint research in support of global pharmaceutical and biopharmaceutical regulation, leveraging its intellectual, scientific and technical resources to advance drug development and regulation to benefit patients.  We encourage you to view the Plan.  We extend a special thanks to the PQRI Board and Steering Committee for their leadership in connection with the development of this plan.

FREE PQRI WEBINAR SERIES:  PQRI’s Biopharmaceutics Technical Committee (BTC) is continuing its free webinar series presented by subject matter experts in the pharmaceutical sciences. This is a unique opportunity to learn about the latest research and regulatory trends on a variety of topics and interact with other experts in real-time all over the world without the need for travel.  See below for information on upcoming and past webinars.  Recordings from past webinars are available for viewing at this link.PQRI BTC 2022 Webinar:  Approaches to Establishing Bioequivalence Safe Space for Orally Administered Drug Products: Applications and Case Studies was held on May 24.  See below for details.

PQRI DTC 2022 Webinar:    Extractables and Leachables Testing for Transdermal Delivery Systems was held on November 2, 2022.  See below for details.

PAST EVENTS

PQRI Workshop: TiO2 Use in Pharmaceuticals – Global Regulatory and Technical ChallengesClick here for post-workshop information. A Workshop Summary is available here.Link to International Pharmaceutical Quality (IPQ) article on the Workshop.

Link to the PQRI Position Paper (as noted above).

If you missed the workshop and would like access to the Workshop recordings, please complete this registration for access (for a nominal fee).

PUBLICATIONS

iBCS 1: Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System (iBCS)

iBCS. 2: Mechanistic Modeling of Pulmonary Availability of Inhaled Drugs versus Critical Product Attributes

iBCS: 3 A Biopharmaceutics Classification System for Orally Inhaled Drug Products

The PQRI iBCS Working Group has published three articles in Molecular Pharmaceutics.  You can access a copy of these article by clicking on the titles above.  PQRI thanks the iBCS WG for all their hard work.

The PQRI Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L recommendations for OINDP have been globally referenced by regulatory authorities. Risk for package-product interaction is highest in OINDP; however, there is a high risk of package-product interaction in parenteral drug products (PDP) and subsequently safety thresholds and best practices specific for PDP were developed. Threshold concepts introduced by OINDP were extrapolated for PDP, are based on daily dose, and include the safety concern threshold (SCT), the analytical evaluation threshold (AET) for compound identification, and the qualification threshold (QT) for identified non mutagenic compounds. The new Recommendation: “Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products” (Intravenous, Subcutaneous, and Intramuscular) describes the E&L strategy for PDP and provides examples for small and large volume parenterals with additional considerations for biological products. Studies to support characterization of materials and simulation for intended use are described with justification for solvent selection, exposure conditions, extract concentrations and analyses. Contributions were made by over ninety individuals who are highly experienced scientists including toxicologists, analytical chemists, and others from industry, and government. It is the hope and intent of the Working Group that the recommendations contained within this document will serve to guide the pharmaceutical development process for PDP and facilitate the approval and manufacture of safe, effective, and quality medicines. The members of the PDP E&L Working Group acknowledge PQRI and its member organizations for providing this forum to make this collaboration possible and the dedicated scientists and regulators that provided the essential information to make these recommendations possible.  Available to download at the link above or at the PDA bookstore.

A companion document that summarized years of studying extractables and leachables in the niche field of ophthalmic drug products, entitled “Principles for Management of Extractables and Leachables in Ophthalmic Drug Products” is available in the PDA Journal of Pharmaceutical Science and Technology.  PQRI thanks the authors and the broader PQRI-PODP Working Group for their hard work.