GMP News - Inspections/Audits

23.09.20

Inspection Report: What Inspectors are looking for

Roughly 10% of deficiencies raised by MHRA inspectors were directly attributable to poor investigations. So what do inspectors observe?

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23.09.20

British Authority Criticizes Insufficient Prevention of Cross Contamination

The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This has been noticed in recent inspections.

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14.09.20

Inspection Observations on Supplier Qualification because of Inspection at Supplier

A US company received an FDA Warning Letter because of problems at their CMO that were not detected in time.

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09.09.20

FDA Warning Letters: Structure and the "Lessons Learnt" Effect

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 

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09.09.20

Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

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02.09.20

Hormones and Homeopathics on the same Equipment: Warning Letter

A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.

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26.08.20

How are FDA Inspections and Applications impacted by COVID-19 Restrictions?

The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

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19.08.20

Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.

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29.07.20

Non Compliance Report for Deficiencies in Contamination Control

In the course of an inspection by the responsible supervisory authorities, considerable deficiencies in GMP compliance were discovered at a Polish manufacturer of non-sterile dosage forms.

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29.07.20

Inspectorates start again with domestic Inspections

Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.

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29.07.20

FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

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22.07.20

FDA Warning Letter: Lack of Lab Data Integrity

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.

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08.07.20

Data Integrity - Do Data Flow Diagrams have to be available?

The topic data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 9: Must data flow diagrams be available?

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08.07.20

Distant Assessment leads to GMP Non-Compliance Report

The Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.

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01.07.20

Warning Letter to Canadian Manufacturers of Injectable Homeopathic Products

The FDA issued a Warning Letter to a manufacturer of aseptic homeopathics in Canada after the deficiencies listed in a 483 letter sent last October were not satisfactorily addressed.

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