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ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

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....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

Canada Ban on Three APIs from India

In late September, Health Canada (HC) banned imports from two Apotex facilities, one API and one finished dosage form facility, and an IPCA Labs API facility, all located in India. The import ban comes as a response to data integrity issues revealed by the U.S. FDA. [For an in depth analysis of data integrity issues […]

FDA Inspection Prompts India’s Ipca Labs to Halt U.S. Exports

In the wake of an FDA inspection, API manufacturer Ipca Laboratories announced in late July that it would voluntarily halt shipments from its Ratlam, India facility “until this issue is addressed,” according to a company press release. The impact will extend to the company’s exports from its Piparia and SEZ facilities in India, which formulate […]

Data Integrity Concerns at Italian API Manufacturer

Trifarma’s API plant in Rozzano, Italy drew a warning letter in July that included data integrity concerns related to maintaining complete data and unauthorized access. Training of employees was also a concern. The letter addressed the findings at a January inspection. [For more on FDA’s recent findings regarding data integrity, see IPQ April 28, 2014.]

Two Foreign API Manufacturers Issued Warning Letters

In June, Apotex and Tianjin Zhongan Pharmaceutical received warning letters addressing API manufacturing issues. Apotex was cited in its letter for data integrity issues at its facility in Bangalore, India, based on inspection findings in late January. The inspection findings resulted in an import alert being placed on products from the facility in April (IPQ […]

EMA Removes Ranbaxy API Plant from Ban

In early June, EMA announced that a reinspection of Ranbaxy’s Toansa, India API plant revealed a number of GMP deficiencies, but no risk to public health, and that the import ban placed on it was being removed. The FDA import alert remains in place after the agency’s follow-up inspection of the plant in January (IPQ […]

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....

IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them

The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....
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