GMP inspections. Data integrity. Deviation investigations.

These were some of the most popular topics addressed in articles published by our experts in 2021. Check out our top 10 and use this list as a guide for your quality and compliance strategy in 2022.

  1. GMP Inspection Case Study Focuses on Inadequate Deviation Investigations
    Why would an FDA investigator consider a deviation investigation to be “inadequate?” Find out in a case study presented by FDA’s Ileana Barreto-Pettit at the International GMP Conference in March 2021.
  2. An Inside Look at China’s Regulatory and Drug Approval Processes
    Jerry Chapman provides coverage of recent changes to China’s drug approval regulations, including drug approval pathways.
  3. FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer
    GMP Consultant Barbara W. Unger analyzes a 38-page 483 issued to a site in New Jersey following an onsite inspection in November 2020.
  4. Case Study of Contaminated WFI in China
    Find out how a company dealt with a contaminated water system at a contract manufacturing site in another country.
  5. FDA Regulators Address Data Integrity and Lab Audit Trails
    Learn about common data integrity findings involving laboratory controls.
  6. FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies
    Jerry Chapman examined the state of virtual inspections in the United States during 2020 in comparison with global regulatory agencies.
  7. Incorrect Specifications, Process Validation Issues at CMO Lead to Adverse Events, Recall
    An FDA investigator provided two case studies involving inspection issues at a contract manufacturing organization (CMO).
  8. Quality Agreements: Part I, Why They are Critical
    Find out what FDA expects in a well-written quality agreement and learn more about regulatory guidance in this area.
  9. FDA FY2020 Drug Inspection Observations and Trends
    Barbara W. Unger provides more insights. This time, she examines 483 observations issued in FY2020 and identifies important inspection trends.
  10. Flawed Process Validation, Ineffective Quality Unit Cited in Warning Letter
    In this case study, an FDA investigator found process validation and quality issues for a drug considered to be in shortage.
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