GMP News - Inspections/Audits

22.04.20

Remote Release and Remote Audits: New Answers from the EU

EMA, EC and HMA have created a Q&A document on regulatory expectations during the covid-19 pandemic. New questions and answers are dealing with remote audits and remote release.

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22.04.20

FDA Warning Letter: No Compendial Methods established? Develop appropriate Testing Procedures by yourself!

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Romania-based manufacturer of an unapproved new drug due to, among others, releasing drug products without conducting identity and strength testing.

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15.04.20

FDA Warning Letter: Incoming Analysis of Raw Materials - Performing only an Appearance Test is not enough

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

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15.04.20

Warning Letter due to Non-Compliance with 3D Rule

A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.

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15.04.20

Warning Letter: Lack of Repairs at US-American Manufacturer

A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.

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01.04.20

Brexit: New Notice to Stakeholders

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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01.04.20

Travel Restrictions: Are Remote Audits an Option?

Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?

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01.04.20

Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter

FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.

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26.03.20

Foreign Particles in Oral Dosage Forms can also Cause Warning Letter

A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.

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26.03.20

Covid-19: FDA Postpones Domestic and Foreign Inspections

In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

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26.03.20

FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs

 In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.

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11.03.20

Lying in an Inspection? Not a good Idea!

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

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19.02.20

Warning Letter: FDA criticizes Supplier Qualification

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.

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17.02.20

Falsified Medicines: New EU Aide Memoire for GDP

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

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17.02.20

Deficiencies in Maintenance, OOS and Data Integrity lead to Warning Letter

A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.

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