The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...

The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...

Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...

In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...

The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...

The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.   The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.   According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer....

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs.   The 27-page draft guidance is part of FDA’s effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017.   According to FDA Commissioner Scott Gottlieb and C...

The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs. FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wron...

The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...

The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...