GMP News - Inspections/Audits

18.05.22

List of Documents Needed during GCP Inspections

The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.

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11.05.22

How many FDA inspections still take place in the EU?

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

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04.05.22

Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection.

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27.04.22

News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

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27.04.22

FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.

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27.04.22

FDA sends Warning Letter to EU Company after Remote Evaluation

A pharmaceutical company in Poland received a Warning Letter from FDA without ever having been inspected on site. It was issued purely on the basis of a remote evaluation.

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26.04.22

FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

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26.04.22

Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

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13.04.22

FDA moves on with Quality Metrics Reporting Program

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.

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13.04.22

FDA Form 483 due to Delayed Stability Testing at a Sterile Injectable Manufacturing Site

In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.

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06.04.22

Manufacturer of "Magic Heal" Receives FDA Warning Letter

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.

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05.04.22

EDQM implements "Real-Time Remote Inspections"

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

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05.04.22

EMA: Update of the "IRIS Guidance Documents"

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.

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17.03.22

How often should GDP Self-Inspections be performed?

According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

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02.03.22

FDA Warning Letter: Key Aspects of the ICH Q7 Guideline disregarded

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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