GMP News - Inspections/Audits

29.01.20

Identity Testing and Stability Studies criticised in an FDA Inspection

The first FDA warning letter of the year goes to a Chinese contract manufacturer of over-the-counter (OTC) drug products for multiple violations of current good manufacturing practice (cGMP).

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22.01.20

Pilot Programme on GMP Inspections of Manufacturers of sterile Medicines

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

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15.01.20

Report: Challenges with FDA Inspections

Report indicates persistent challenges and concerns with FDA foreign inspections.

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15.01.20

FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

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08.01.20

Warning Letter for inadequate OOS Investigations and Complaint Handling

The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.

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08.01.20

Warning Letter for not meeting FDA/USP Requirements

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).

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08.01.20

US Manufacturer of homeopathic Medicines and nutritional Supplements receives FDA Warning Letter

From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a Warning Letter from the FDA.

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11.12.19

PIC/S: How Inspectors should evaluate a PQS

The PIC/S has published a draft Recommendation on risk-based change management within the PQS.

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11.12.19

Warning Letter for U.S. Manufacturer due to Defects in Equipment, Stabilities and Complaints

In September, a US pharmaceutical manufacturer received a Warning Letter from the FDA due to GMP violations in the areas of equipment cleaning, drug stability and handling complaints.

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20.11.19

New Warning Letter - Quality Oversight in the Focus

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

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13.11.19

Batch Release without Determination of Identity and Strength and other GMP violations - A Look at FDA's Warning Letters over the Last Months

FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.

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06.11.19

Another FDA Warning Letter for inadequate CAPAs

Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.

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30.10.19

Data Integrity Violations detected by the FDA at US Company

Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.

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24.10.19

Warning Letter: Deficiencies in Validation and OOS

Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

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02.10.19

FDA criticizes Lack of Compliance with ICH Q7 Guidance

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

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