Quality Systems

The authors detail the possible consequences of noncompliance and a lack of quality control.

Q&A with Peter Smith and David Elder, Strategic Compliance Consulting, PAREXEL International, on acceptable deviation investigations. Smith and Elder are both former senior officials with FDA.

On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.

The European Medicines Agency has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA's review of all fourteen centrally authorized medicines that were produced at the site.

FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.

CML - Quality Assurance

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

In a world where product recalls can mean the end of a company, all batches must be perfect.

Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.

Brazil's generic-drug market is growing steadily.

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

SOCMA's Bulk Pharmaceuticals Task Force outlines key goals and challenges for user-fee legislation.

Has the long-awaited guidance answered all of the industry's questions?

Social media use raises questions about applying old standards to new information technology.

FDA's treatment of whistleblowers lacks internal consistency.

A Q&A with Chris Meissner, president of Meissner Filtration Products, on recent industry trends.

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

The article examines some recent developments for this process step and for continuous manufacturing overall.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

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.