The US FDA has cited failure to assure an adequate cleaning system at Jubilant Life Science Spokane, Washington State facility, in a recent Warning Letter issued to the firm.
Drugmakers seeking ANDAs for certain solid dose, extended-release drugs will need to test what impact alcohol has on their products under new draft guidance on bioequivalence issued by the US FDA.
A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.
Actavis says it is restructuring a Californian manufacturing facility at a cost of 56 jobs weeks after the announced closure of a plant in North Carolina.
The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill” last night.
US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.
Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept of quality-by-design (QBD) that focuses mostly on design space verification.
The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal and civil liability.
Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
An IPEC-affiliated coalition is calling on USP (US Pharmacopoeia) to allow for the determination of physiologically relevant bioaccessible elemental impurity content for pharmaceutical products and components.
Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.
In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes...
The US Food and Drug Administration (FDA) will soon run out of funding for the limited amount of medical product regulatory work it has carried out during the Government shutdown according to an agency spokesman.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
The Ghanaian FDA has defended its decision to ban all imports from India' Bliss GVS amid growing industry concerns about the speed of the agency's decision making.
Furloughed US FDA staff will face a huge backlog of manufacturing plant inspections when the Government shutdown eventually ends, according to an influential healthcare advocacy group.
In a move that could be a sign of a changing tide in India, the Ministry of Health and Family Welfare said the government will invest almost $3bn (€2.2bn) to add hundreds of new inspectors for drug manufacturers and other oversight initiatives that could...
Bliss GVS says allegations of supplying fake medicines and a blanket ban imposed on its products by the Food and Drugs Authority Ghana (FDA) are both “harsh” and “baffling.”
Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.
India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
After nearly 50 years in use, UK’s MHRA is now looking into whether it should update and replace its system for reporting drug side effects to increase incident reporting and decrease confusion.
The use of "flaking" and non-sterile gloves in aseptic processing, as well as cGMP violations, has led to the the US FDA issuing a warning letter to Agila for its Bangalore, India plant.
A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.
US scientists have claimed that ‘bacterial autopsies’ could accelerate the discovery of new antibiotics in an announcement made just days after the US CDC warned of a potential “post-antibiotic era” and called for renewed development efforts.
The California Board of Pharmacy is proposing to amend the state pharmaceutical track-and-trace legislation to exempt wholesalers from e-pedigree requirements in cases where manufacturers directly ship drugs to pharmacies.
After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
The EMA has announced plans to change how it reviews drugs and inspects production facilities by 2014 as part of a wide ranging restructuring programme.
After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
Johnson & Johnson is battling another onset of quality concerns as its subsidiary Janssen is pulling one lot of its Risperdal Consta injection in the US due to a mold contamination.
Regulators in Southeast Asia say draft process validation guidelines issued for consultation last week are a work in progress and likely to change as discussions continue.
Knowing about manufacturing innovations as soon as possible is more important for BioPharmas than for their small molecule counterparts according to an MIT Professor interviewed by our new sister site BioPharma-Reporter.com
