Quality Systems

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

Traditionally more prevalent in less industrialised regions, counterfeit medicines are now more frequently entering the heavily regulated supply chains of EU countries.

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, Nebraska, facility of Novartis Consumer Health, where the product is made.

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

On Feb. 21, 2011, FDA posted a copy of a Warning Letter that was sent to the chairman of the executive board of Merck KGaA on Dec. 15, 2011, regarding cGMP violations identified at three of its European facilities: MS-Corsier-sur-Vevey, MS-Aubonne, and MS-Tiburtina.

EMA Releases Genetic Variability Guideline.

FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.

The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.

FDA Addresses the Regulation and Approval Process of PET Drugs.

After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Guidance offered on how to deal with off-label information requests.

Where is the variability coming from and what have we done to minimize it?

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.

New educational programs are key to the industry's future and to safe, available drugs.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

New product reviews for February 2012.

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

ICH Q8, Q9, and Q10 support and implications for the future.

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.