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IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential

The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....

Ph. Eur. Requests Comments on Inhaled Drug QC Methodologies

The Inhalanda Working Party of the European Pharmacopoeia issued an inquiry in August, seeking comments and/or data on Abbreviated Impactor Measurement(AIM) and Efficient Data Analysis (EDA) methodologies for the quality control of inhaled drugs. The working party is looking for information that shows whether AIM and/or EDA can be effectively used in the quality control […]

FDA Releases Draft Guidance on Vial Overfills

FDA released a draft guidance in mid-March to better define acceptable practices regarding the overfilling of vials. The guidance, open for comment until June 12, illustrates the best use of overfilling to achieve accurate doses, while preventing contamination.

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

IPAC-RS is Advancing GMP Consciousness Among Inhalation Product Component Suppliers; New PS 9000 Will Allow Certification

The multi-faceted effort by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) to instill the quality management concepts detailed in its component GMP guidelines into the complex supply chain for orally inhaled and nasal drug products (OINDPs) is continuing to bear fruit....

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