PQRI WORKSHOP ON EXCIPIENT TESTING and CONTROL STRATEGIES

The PQRI Workshop on Excipient Testing and Control Strategies is designed to provide industry, FDA and USP an opportunity to interact on topics related to the testing and release of excipients. It will consider in detail the results of a recently conducted PQRI industry-wide survey on the control of pharmaceutical excipients. This will be the first time that survey participants will meet face to face to discuss their concerns and experiences. Through discussions with FDA and USP, industry will become aware of and be encouraged to use the tools already in the regulations. Participants will gain confidence that any petitions for regulatory changes emerging from the survey and this workshop will be relevant to both public safety, and manufacturing efficiency. It is anticipated that the discussions will result in a better understanding of how industry-wide tests for physical characterization of excipients help build quality into drug products.

The objectives of this important two-day Workshop are:

• Provide a report on the Survey of Excipient Testing and Control Strategies, and determine the impact of those findings on stakeholders.
• Gather information on, and hold round table discussions on the impact of FDA regulations and guidances on excipient control strategies and how to use them correctly and effectively.
• Based on the survey information and conference discussions the participants will:
• Identify concerns of stakeholders - including excipient manufacturers, drug product manufacturers, regulators, and USP.
• Communicate and clarify regulations
• Develop stakeholder recommendations and ideas for potential changes in compendia, guidances and regulations to minimize regulatory burden

The Workshop will deliver:

• A Summary of the PQRI Excipient Survey results which will provide a platform for Workshop discussions, and possible solutions to current issues and concerns of stakeholders.
• A Joint Position Paper from Excipient Manufacturers, Drug Product Manufacturers and USP on key excipient issues. This paper will be a result of the Workshop discussions.
• The definition of "Continuous flow Manufacturing Process (or Continuous Process)" as currently used by excipient manufacturers does not clearly define a lot. This workshop will attempt to gather information about continuous manufacturing processes used by excipient manufacturers, and work towards arriving at a commonly agreed upon definition of a "lot" or "batch" of material produced using a continuous flow manufacturing process. The workshop will discuss commonly used ways to control and communicate the quality attributes of excipients manufactured using a continuous flow process.
• Skip lot testing is not currently used effectively and efficiently by stakeholders, and this workshop will help discuss and identify best practices for the use of "skip lot" testing based on scientific rationale and risk analysis.
• Following the spirit of FDA’s 21st Century Pharmaceutical CGMP and QbD initiatives, the workshop will explore ways to improve pharmaceutical product quality by characterization and control of physical and chemical properties of critical excipients used in a given product.
• Third party audits of excipient manufacturers, particularly those located outside the US, are critical to a control strategy for the global excipient supply chain. The use of independent third party audits may provide a cost effective way to accomplish control and ensure quality of excipients, especially for smaller pharmaceutical manufacturers. The concepts and advantages of independent third party audits will be described.
• There is an increasing danger of excipient manufacturers not producing pharmaceutical grade excipients that meet USP-NF criteria, which creates an enormous problem for the drug product manufacturers. This may lead to withdrawal of the compendial standard from USP-NF due to lack of availability of compendial grade material. The workshop will assess these issues, and propose solutions to prevent the problem of having reduced number of excipients labeled USP-NF.
• By increasing the pace of global harmonization, industry stakeholders are expecting to reduce the overall testing requirements significantly. The workshop will assess the status of harmonization and will recommend how to effectively use harmonized monographs, and reduce the testing burden of pharmaceutical excipients.

Click here to print out the PQRI Workshop Tentative Program on Excipient Testing and Control Strategies

PRESENTATIONS

PQRI Opening Session

Continuous Flow Mfg Skip-Lot Sampling

How Characterization of Excipient Physical and Chemical Properties Helps Build Quality Into Drug Products

Third Party Audit: Advantageous or Risky?

Strategies to Increase the Number of Excipients Labeled USP-NF

When is Excipient Reduced Testing Appropriate?

Regulatory Aspects of Pharmaceutical Excipients

Closing Presentation: Continuous Flow Mfg Skip-Lot Sampling

Closing Presentation: How Characterization of Excipient Physical and Chemical Properties Helps Build Quality Into Drug Products

Closing Presentation: Increased Use of Third Party Audits

Closing Presentation: Strategies to Increase the Number of Excipients Labeled USP-NF

Closing Presentation: When is Excipient Reduced Testing Appropriate?