GMP News - Inspections/Audits

01.12.21

TGA: On-going use of Remote Inspections

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

24.11.21

New FDA Commissioner - Online FDA Symposium available free of Charge

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

17.11.21

In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

10.11.21

Fire in Production! What are appropriate CAPAs?

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

03.11.21

EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

03.11.21

Contract Manufacturing as a Topic in a new Warning Letter

Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

27.10.21

GMP Inspections: Do you know IRIS?

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

27.10.21

Inspection Deficiencies in Process Equipment increase

The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.

27.10.21

Particles lead to Warning Letter for Japanese Sterile Manufacturer

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

20.10.21

FDA Warning Letter: Deficiencies in API / Finished Drug Product Testing and Stability Program

The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

20.10.21

Numerous FDA 483s due to Deficiencies in the Stability Program

Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.

13.10.21

Lack of Scientifically Sound Laboratory Controls often mentioned in FDA 483s Reports

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.

13.10.21

Inadequate Sampling Plans lead to FDA 483 Inspection Report

Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.

13.10.21

FDA criticizes Manual Visual Inspection

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

06.10.21

EU: further Extension of GMP and GDP Certificates

The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.

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1 June 2022

GMP News - Inspections/Audits

TGA: On-going use of Remote Inspections

New FDA Commissioner - Online FDA Symposium available free of Charge

In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Fire in Production! What are appropriate CAPAs?

EU: Important Document for Inspections revised

Contract Manufacturing as a Topic in a new Warning Letter

GMP Inspections: Do you know IRIS?

Inspection Deficiencies in Process Equipment increase

Particles lead to Warning Letter for Japanese Sterile Manufacturer

FDA Warning Letter: Deficiencies in API / Finished Drug Product Testing and Stability Program

Numerous FDA 483s due to Deficiencies in the Stability Program

Lack of Scientifically Sound Laboratory Controls often mentioned in FDA 483s Reports

Inadequate Sampling Plans lead to FDA 483 Inspection Report

FDA criticizes Manual Visual Inspection

EU: further Extension of GMP and GDP Certificates

Recommended Event

ECA - Live Online Training - QP pre-course Session Interpersonal and Soft Skills for the QP

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