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  • Regulatory NewsRegulatory News

    Novartis Makes New Data Integrity Commitment

    Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the US Food and Drug Administration (FDA). “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible all...
  • Regulatory NewsRegulatory News

    FDA Warns Jubilant, Pfizer Subsidiary in India

    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...
  • Regulatory NewsRegulatory News

    FDA Warns Spanish Firm Over GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.   FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter a...
  • Regulatory NewsRegulatory News

    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
  • Regulatory NewsRegulatory News

    Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

    The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.   A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However,...
  • Feature ArticlesFeature Articles

    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility. The warning letter comes after a four-day inspection of the facility last May that resulted in FDA placing the firm on import alert in late June. During the inspection, FDA says its investigator "observed rodent feces throughout [the] facility," incl...
  • Regulatory NewsRegulatory News

    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese API Maker for Data Integrity Issues

    The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year. Background In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequa...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
  • Regulatory NewsRegulatory News

    FDA Warns Two Drugmakers in China and India for Data Integrity Violations

    The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year. Data integrity has been a growing area of focus for FDA, with an increasing number of warning letters and Form 483s citing data integrity violations, many for manufacturers in China and India. USV Warning Let...
  • Regulatory NewsRegulatory News

    FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance

    The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues. In a warning letter dated 17 February, FDA details six violations uncovered during a month-long inspection of the Morton Grove, Illinois facility in January and February 2016. In 2014, FDA issued the site a Form 483 detailing 12 observations covering product testing, recordkeeping and data integrity issues. In a filing ...