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QA/QC

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US FDA questions data integrity in warning for Indian drugmaker

26-Feb-2014 - Failing to ensure data integrity at a control laboratory in India has landed drugmaker USV with a US FDA warning letter.

Pfizer thyroid drug back in production after packaging prob caused a stink

26-Feb-2014 - Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.

UPDATE-2

Ranbaxy voluntarily halts production at its Indian API plants

25-Feb-2014 - Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.

US FDA's 'super-office' to focus on all things quality, home and away

24-Feb-2014 - Development of a new quality "super office" was motivated by a desire to simplify oversight and is not a response to the recent spate of problems at overseas suppliers, says the US FDA.

Great Excipact-ations: more excipient firms certified as predicted

20-Feb-2014 - Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.

US FDA recruiting more inspectors in India as Hamburg pushes need for quality

19-Feb-2014 - As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the country.

US to expedite imports for some drugmakers under new supply chain plan

19-Feb-2014 - The US FDA announced on Monday that it would initiate a Secure Supply Chain Pilot Program to enhance the security of imported drugs.

Hospira confident 'swamp is drained' as US FDA ups status of Rocky Mount

13-Feb-2014 - The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated) status though its 2010 Warning Letter still stands.

Lack of Quality Unit equals US FDA Warning for Hong Kong API firm

13-Feb-2014 - A Hong Kong API distributor has received a Warning Letter from the US FDA after failing to have a Quality Unit and incorrectly labelling products.

Amgen plant hit with US FDA Warning over Enbrel combination product

12-Feb-2014 - The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.

Excipact scheme launched as independent not-for-profit alliance

11-Feb-2014 - The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.

NSF acquires IPEC auditing arm

11-Feb-2014 - NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.

FDA: shortage mitigation measures working thanks to drugmakers

06-Feb-2014 - US drug regulators have claimed recent law changes that enhance communication with pharmaceutical manufacturers helped prevent 140 potential drug shortages in 2013. 

Chicken pox vaccine shortage likely after problems at GSK plant

03-Feb-2014 - Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.

GSK: Halt in chicken pox vaccine manufacture to continue into Q2

31-Jan-2014 - Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.

CordenPharma certified to handle HPAPIs under SafeBridge safety programme

30-Jan-2014 - CordenPharma has received certification of Potent Compound Safety at a US plant and joins a growing list of drugmakers looking to assure HPAPI safety, according to SafeBridge Consultants.

Daiichi says new API import ban will affect Ranbaxy's US ops

27-Jan-2014 - Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.

Hospira intent on growing Indian ops as EU market beckons

23-Jan-2014 - Increased in-house API production and manufacturing in India will lower the costs of Hospira’s injectables, the firm says, as it looks past current remediation efforts.

A QP for GMP? That is the suggestion: IRCA launches pharma auditor training

16-Jan-2014 - GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.

Packaging fault takes Merck's Liptruzet off US market for foreseeable future

15-Jan-2014 - The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.

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