GMP News - Pharmaceutical Technology

02.06.21

New USP Chapter on Visual Inspection of Parenterals?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

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12.05.21

New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

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11.03.21

Medical Gases: WHO publishes Draft Guideline

In February 2021, the WHO published the new Guideline "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" on the manufacture, testing, storage and distribution of medical gases for comment. The reason for the WHO to create this new guideline is the increased demand for oxygen for ventilation due to the Corona pandemic.

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16.12.20

Avoiding Non-Compliance in Packaging Areas

Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.

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09.12.20

Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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28.10.20

Warning Letter to Indian Manufacturer: Dead Legs and Missing Validation

Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

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21.10.20

Warning Letter for US Repacker: Deficienceis in Cleaning and Stabilities

A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

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14.10.20

GMP Deficiencies in Packaging

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

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23.09.20

Deficiencies in Media Fills and Smoke Studies: Warning Letter

A US-American pharmaceutical manufacturer was inspected by the FDA in February 2020. Due to serious deficiencies in the media fills and smoke studies in the aseptic area, the manufacturer has now received a Warning Letter.

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23.09.20

British Authority Criticizes Insufficient Prevention of Cross Contamination

The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This has been noticed in recent inspections.

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02.09.20

Survey Results on the Use of Electronic Documentation in Equipment Qualification

Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Would it not be possible to use more qualification documents electronically? This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic.

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02.09.20

Hormones and Homeopathics on the same Equipment: Warning Letter

A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.

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26.08.20

Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.

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12.08.20

WHO Pharmaceutical Water Guideline: Revision goes into next Round

The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.

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05.08.20

New Edition of the VDI Standard on Hygiene Training for HVAC Systems

The VDI (Verein Deutscher Ingenieure, Association of German Engineers) has re-issued Part 2 of VDI Standard 6022 on the requirements for hygiene training of persons entrusted with HVAC systems. The latest valid version of this document dates from 1999.

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