Drug GMP Report

BALTIMORE — CDER is exploring the creation of a new Office of Pharmaceutical Quality (OPQ) that would oversee quality throughout a drug’s lifecycle — partially by promoting GMP standards in the preapproval setting, FDA officials say.

An effective corrective and preventive action (CAPA) program will prioritize prevention and continuity in process improvement — primarily by linking to manufacturing systems beyond those concerned with deviation management and failure investigations, compliance experts say.

Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.

BALTIMORE — While the new FDA user fee bill links supplier quality agreements (SQA) to drugmakers’ oversight responsibilities for the first time, it’s not likely such accords will be the focus of inspections any more than they are now, FDA officials say.

Qualitest, a subsidiary of Endo Health Solutions, is recalling one lot of its hydrocodone bitartrate and acetaminophen tablets because some may exceed the weight specification and could be super potent.

BALTIMORE — Drugmakers’ quality control checklists make it difficult for inspectors to interpret manufacturing failures and foster a true understanding of mistakes, regulators and industry officials say.

Amphastar Pharmaceuticals is slow to notify the FDA about complaints of serious and/or unexpected adverse events associated with its various generic drug products, a Form 483 states.

Brioschi Pharmaceuticals, a maker of antacid products, was handed a Form 483 for lax investigations into out-of-specification lots released to market and complaints of odiferous drugs.

Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable.

The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.

Genzyme is voluntarily recalling nine lots of its kidney transplant drug Thymoglobulin after one product lot failed a periodic stability test, the Sanofi subsidiary says.

In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products.

DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter.

Novartis is launching an in-house campaign to underscore employees’ “personal responsibility” for quality as the company’s manufacturing remediation continues.