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Cooperative Supply Chain Integrity Efforts Important to Support Advancing Track-and-Trace/Authentication Technologies and QC Analytical Methods

Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes....

Update From FDA on its Secure Supply Chain Pilot Coming Soon; Regulation, Legislation and Guidance Efforts Advance in US and EU

A status update and further announcements from FDA on its “Secure Supply Chain” (SSC) pilot program, intended to help promote the safety of active ingredients and drug products imported into the US, is expected soon....

MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings

Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective....

Gemfibrozil Manufacturing Problems at Sun’s NJ Facility Among Issues Prompting FDA Warning Letter

Gemfibrozil manufacturing problems resulting in imploding sample bottles and unknown impurities and how they were responded to were central concerns highlighted in an FDA warning letter to Sun Pharmaceuticals in late August regarding inspection findings at the Indian generic drug company’s Cranbury, New Jersey facility....

Warning Letters to Two Overseas Sterile Ophthalmic Manufacturers Cite Similar Microbial Control Practices

FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination....

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....

FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....

IPQ’s August “Monthly Update” on Key CMC/GMP Developments in the US, Europe, and Internationally is Now Available

Included in the US coverage in IPQ’s just-released “Monthly Update -- August 2010” is advice from FDA biotechnology regulators on how to communicate with the agency to avoid CMC stumbling blocks and smooth the development, IND and marketing application clearance process for new biotech products. On the inspection side, in focus are: ● Congressional efforts to upgrade FDA’s recall and supply chain authorities ● the latest on McNeil’s compliance issues and the impact on J&J finances ● the new inspection initiative by CDER putting Part 11 back in the limelight, and ● a warning letter to Sanofi that shows FDA’s ongoing concern with vaccine manufacturing.

FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems

FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products....

New Oral Formulation Approaches Are Accelerating Product Movement Into the Clinic

The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles....
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