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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....

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program

Detailed, transparent technical discussions with suppliers, long-term supplier relationships, and a wide-ranging event monitoring system are three prongs in Amgen’s intensive effort to avoid supply disruptions and improve quality assurance....

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

Impax’ 483 in Taiwan Includes CoA Concern

A 483 issued to Impax Labs oral solid facility in Taiwan in late July underscores FDA’s current concern with overreliance on a component supplier’s certificate of analysis (see IPQ April 17, 2014 and July 27, 2014). Other of the 10 observations on the 483 address equipment validation, specification testing, rejection of OOS product, and process […]

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]

HDMA Publishes Guidance on Distributor Compliance with DQSA

In late April, the Healthcare Distribution Management Association (HDMA) published a guidance meant to help distributors comply with the drug supply chain security provisions of DQSA.

Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain

Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide....

EC Publishes Q&A on GDPs

In late March, the European Commission published a “question and answers” (Q&A) related to its new guideline on Good Distribution Practice for medicinal products for human use, which went into effect in November 2013. The document contains 25 Q&As. The questions focus on: ● competence and training of personnel ● segregation of products ● temperature […]
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