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Archive for ‘August, 2011’

FDA Releases Draft Guidance on Tablet Scoring

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August 31, 2011 | Posted in CMC Standards, Formulation, News Brief, Oral, Region/International, Specific Product Type, US/Canada | Read More »

IPQ’s Monthly Update for July/August is now available

The problems that have been surfacing with glass vials and syringes – and what firms and regulators are doing to understand them better and improve control practices – are spotlighted in IPQ’s July/August Monthly Update (the once-a-month publication cycle resumes in September)....
August 26, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — July/August 2011

The Monthly Update covering key CMC and GMP developments in the US, Europe and internationally during July and August is now available.
August 26, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

Latin America Diverges Widely on CMC Requirements; Harmonization Effort Continues Through PAHO

While momentum is growing in Latin America for more harmonization around the technical requirements for registering pharmaceuticals, currently there are significant divergences among the countries in the region regarding the expectations for the form and content of CMC submissions....
August 22, 2011 | Posted in CMC Review Policy, International Harmonization, Latin/South America, Marketing Application/General, Region/International, The News in Depth, WHO | Read More »

Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD

The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables....
August 15, 2011 | Posted in Asia, Biotech Therapeutics, Component Supply, Europe, Injectable, International, Region/International, Specific Product Type, Supply Chain/GDPs, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions

Amgen’s extensive investigation into the glass lamellae problems it experienced with Epogen, which has included the development of characterization techniques, narrowing down of causal factors, and evaluation of glass manufacturing processes, sheds new light on biopharma’s glass control challenges and the approaches to addressing them....
August 10, 2011 | Posted in Component Supply, GMP Enforcement Activity, GMP Policy, Injectable, Product Type Specific, Recalls, Region/International, Specific Product Type, Supply Chain/GDPs, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage

The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance....
August 7, 2011 | Posted in CMC Standards, Compendial, Injectable, International Harmonization, Pharmacopeias, Region/International, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics

Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes....
August 7, 2011 | Posted in Asia, Biotech Therapeutics, Combinations, Europe, GMP Enforcement Activity, Injectable, Recalls, Region/International, Specific Product Type, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality

A PDA-sponsored survey of drug and biologic manufacturers reveals a wide disparity among the practices and approaches being taken to ensure the quality of glass vials and syringes and the products they contain....
August 3, 2011 | Posted in Biotech Therapeutics, Injectable, Shipping & Storage, Supply Chain/GDPs, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny

A sharp uptick in the number of sterile product recalls due to glass breakage, defects and delamination have the industry, their glass suppliers, and FDA taking a hard look at the reasons for the increase and what can be done to reverse the trend....
August 3, 2011 | Posted in Biotech Therapeutics, GMP Enforcement Activity, GMP Policy, Injectable, Product Type Specific, Recalls, Specific Product Type, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

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