The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.
Industry still facing Problems with Root Cause Investigations
Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.
API Testing in the Focus of the Inspections of the U.S. FDA
In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.
FDA sends Warning Letter to Australian OTC Drug Products Manufacturer
The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.
FDA Warning Letter Highlights the Importance of Analytical Methods Validation and System Suitability Tests
In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.
FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients
The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.
Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents
Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.
Deficient Cleaning and Transfer of a Non-Validated Manufacturing Process Lead to a Warning Letter
During an inspection of an Indian pharmaceutical manufacturer by the FDA, several serious deficiencies were discovered. For example, the cleaning of multipurpose equipment was criticised, and the transfer of a non-validated manufacturing process led to further complaints. Read more here.
US Congress is concerned about FDA Inspection Backlog
In a letter sent directly to Janet Woodcock, FDA, the Congress of the United States expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.
EDQM's Experience with Real-Time GMP Remote Inspections
"Innovation overcoming adversity". This is the title of a publication by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on the topic of "Real-Time Remote Inspections" (RTEMIS).
International Inspections: TGA and the Management of GMP Compliance Signals
The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.