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  • ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join

    While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future. Paul Hargreaves, chair of PIC/S, explained to attendees at the P...
  • Regulatory NewsRegulatory News

    FDA Warns Pan Over Data Integrity, Sanitation Issues

    For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities. Due to the extent and repeat nature of the violations, FDA says Pan must carry out a comprehensive plan to investigate and address the issues. Data Integrity and Quality Control The warning letter, dated 25 August 2016, comes...
  • Regulatory NewsRegulatory News

    FDA Warns Indian API Maker Unimark for Deviations at Two Facilities

    The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India. During the inspection, FDA officials spotted birds and a lizard at one of the sites, marking the second time FDA has warned Unimark over data integrity issues and the presence of such pests in less than a year. According to the warning let...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • Regulatory NewsRegulatory News

    Data Integrity: New Draft Guidance and Q&A

    The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines. The 44-page PIC/S draft guidance, known as “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments,” is focused on providing ind...
  • Regulatory NewsRegulatory News

    FDA Warns Two Chinese Drugmakers for Data Integrity Violations

    The US Food and Drug Administration (FDA) has issued warning letters to two Chinese drugmakers over manufacturing and data integrity issues, including backdated tests and falsified records. The two companies, Chongqing Lummy Pharmaceutical Co., Ltd. (Lummy) and Shanghai Desano Chemical Pharmaceutical Co., Ltd. (Desano), manufacture and sell drugs in China, as well as produce active pharmaceutical ingredients (APIs) for companies abroad. Focus covered FDA's inspection ...
  • Regulatory NewsRegulatory News

    FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

    Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday. For the Italian site, which produces both APIs and finished drugs, FDA’s inspection from last May (warning letter was sent 24 May 2016) uncovered sterility concerns, including visible “black ...
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    CDSCO Offers Risk-Based Checklist for Indian Pharma Manufacturing Inspections

    India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India. The checklist and tool will help CDSCO and state inspectors understand and collaborate on which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are compliant. “The inspections are planned to be carried out jointly by the CDSCO offici...
  • Regulatory NewsRegulatory News

    EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

    The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility. EMA says it is conducting its review based on the issues raised by recent notices from the US Food and Drug Administration (FDA) and World Health Organization (WHO). According to EMA, th...
  • Regulatory NewsRegulatory News

    FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable

    Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...
  • Regulatory NewsRegulatory News

    Another FDA Warning Letter for an Indian Drugmaker: More Data Integrity Violations

    The US Food and Drug Administration’s (FDA) interest in rooting out data integrity deficiencies among Indian pharmaceutical manufacturers continued this month with a warning letter issued to Hyderabad-based Sri Krishna Pharmaceuticals. A lack of data audit trails, deleted sample data by a quality control analyst and loose computer controls that allowed analysts to manipulate data were all examples of issues cited by FDA officials from their inspection in December 2014. M...
  • Regulatory NewsRegulatory News

    Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

    The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as re...