GMP News - Inspections/Audits

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.

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.

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.

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?

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.

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.

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.

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.

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.

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?

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).

24.02.22

ANVISA: Version 2 of the CADIFA Manual for APIs available

The second version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and needs to be followed for API dossiers.

16.02.22

US Gov. Office asks FDA to improve Foreign Inspection Program

The US Government Accountability Office (GAO) has released a report to Congress entitled "FDA Should Take Additional Steps to Improve Its Foreign Inspection Program".

15.02.22

GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

09.02.22

Warning Letter: API Testing still in the Focus of the U.S. FDA

In January 2022, the U.S. FDA issued a Warning Letter to an Indian drug manufacturing site called "Aurobindo Pharmaceutical Limited" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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GMP News - Inspections/Audits

FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

FDA sends Warning Letter to EU Company after Remote Evaluation

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

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

FDA moves on with Quality Metrics Reporting Program

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

Manufacturer of "Magic Heal" Receives FDA Warning Letter

EDQM implements "Real-Time Remote Inspections"

EMA: Update of the "IRIS Guidance Documents"

How often should GDP Self-Inspections be performed?

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

ANVISA: Version 2 of the CADIFA Manual for APIs available

US Gov. Office asks FDA to improve Foreign Inspection Program

GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

Warning Letter: API Testing still in the Focus of the U.S. FDA

Recommended Event

Data Integrity and Good Documentation Practice GMP-compliant instructions and records

GMP News - Inspections/Audits

FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

FDA sends Warning Letter to EU Company after Remote Evaluation

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

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

FDA moves on with Quality Metrics Reporting Program

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

Manufacturer of "Magic Heal" Receives FDA Warning Letter

EDQM implements "Real-Time Remote Inspections"

EMA: Update of the "IRIS Guidance Documents"

How often should GDP Self-Inspections be performed?

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

ANVISA: Version 2 of the CADIFA Manual for APIs available

US Gov. Office asks FDA to improve Foreign Inspection Program

GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

Warning Letter: API Testing still in the Focus of the U.S. FDA

Recommended Event

Data Integrity and Good Documentation Practice GMP-compliant instructions and records

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