GMP News - Inspections/Audits

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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24.06.20

FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.

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17.06.20

MRA: 25% less FDA Inspection in the EU

In 2019 the US Food & Drug Administration FDA was able to reduce 25% of routine surveillance inspections in the European Union, as reported by the authority.

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17.06.20

Serious Deficiencies at US Sterile Manufacturer

The FDA has recently published a Warning Letter following an inspection conducted at a US-American manufacturer of ophthalmic sterile preparations, which revealed numerous serious deficiencies. These include environmental monitoring, lab data integrity, gowning procedures, media fill and maintenance/cleaning of production equipment.

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03.06.20

FDA Warning Letter to US Drug Maker

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

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27.05.20

Is Cannabis an API, a Herbal Drug or a Herbal Medicinal Product?

The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

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26.05.20

COVID-19: How to manage temporary GDP Process Changes and Risks

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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13.05.20

More and more Inspectorates are performing Remote Inspections

TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.

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