GMP News - Inspections/Audits

07.02.24

New FDA Warning Letter because of inadequate Quality Oversight

The FDA recently issued a Warning Letter to a pharmaceutical company in Thailand for violating CGMP regulations and expectations on Quality Oversight.

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31.01.24

Two FDA Warning Letters: Identity Testing of Incoming Components

The U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States. In both cases, the firms did not demonstrate that they adequately tested each shipment of each lot of the incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.

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31.01.24

EMA publishes new questions and answers on Annex 1

At the beginning of 2024, the EMA added 4 new questions and answers to its catalogue of frequently asked questions from the GMP and GDP area.

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24.01.24

FDA Warning Letter: Testing of incoming Goods

In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023. According to the WL, the firm failed to do proper incoming control tests for identity of their raw materials.

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24.01.24

Failure to Respond to Multiple FDA Requests leads to Warning Letter

Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter.

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24.01.24

FDA Warning Letter to Turkish Manufacturer of Drugs, Cosmetics and Detergents

Even with increasing distance to the pandemic situation, manufacturers of disinfectant products still seem to be relying on less stringent controls. After a large number of Warning Letters regarding hand sanitizers with contaminated or poorly analyzed products in the Americas and Southeast Asia, a Turkish company is now affected. The company Sudesan in Istanbul received a Warning Letter from the FDA listing several deviations.

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17.01.24

FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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10.01.24

FDA Form 483: Calibration of Analytical Instruments

On 29 November 2023, a new FDA Form 483 that goes back to an inspection in October at a company in India was published. The 23-page report lists a total of 10 observations. Beside others, laboratory equipment including HPLCs, GCs, and UV Spectrophotometers used in commercial release and stability analysis were observed not meeting the calibration specifications.

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10.01.24

EMA/CMDh: Update Q&A Document for Nitrosamines

The current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). In December 2023, Appendix 1 was updated and now contains five additional substances.

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20.12.23

Does a Defect Rate of 0.011% justify a Warning Letter?

In a recent Warning Letter from the US FDA, the authority refutes a medicinal product manufacturer's argument that a failure rate of 0.011% does not trigger further action. How does the FDA argue here?

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13.12.23

EU and MHRA extend GMP and GDP Certificates

The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.

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13.12.23

ICH Q9 Training Package for Revision 1 published

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

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06.12.23

Further Warning Letters after Remote Evaluations by FDA

Two pharmaceutical companies had received a Warning Letter from FDA without ever having been inspected on site. This was purely on the basis of a remote evaluation.

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06.12.23

China tightens Counterespionage Law - Risk for Audits and Inspections?

China has passed a revised counter-espionage law that extends the powers to combat espionage. This increases the legal uncertainty for GMP inspections and audits.

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06.12.23

FDA Warning Letter: Inadequate Testing of BZK and Many General GMP Violations

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

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