GMP News - Pharmaceutical Technology


Inadequate Equipment and Facility Design

A sterile manufacturer in Jordan received a Warning Letter from the US FDA for inadequate equipment and facility design as well as other deficiencies.



Indian Sterile Facility in a Dilapidated Condition

During an inspection carried out in October 2022, the FDA found unsanitary and dirty conditions at a sterile manufacturer in India, resulting in a Warning Letter.



Air-Tightness of Cleanrooms & Containment Solutions: VDI 2083 Part 19 Updated

The question of how tight the cleanrooms must be needs to be answered as early as the planning phase of a facility. The DIN EN 15727 standard and the new version of VDI Guideline VDI 2083 Sheet 19 provide assistance. Read more here.



New USP Chapter on Cured Silicone Components

The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.



Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian pharmaceutical Company

A non-compliance report was issued by the inspecting Maltese authority following an inspection at an Indian pharmaceutical manufacturer. The inspection was the follow-up inspection to an inspection already carried out in 2022, which was intended to monitor the implementation of the measures. According to the authority, the remaining deficiencies and risks of cross-contamination were problematic.



FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.



Cleanroom Pressure Control: Where should the 0 Reference be measured?

The protection concept in pharmaceutical cleanrooms is realised by the different cleanroom classes, zones and their separation by pressure levels. A frequently asked question here is: where and how should the reference, i.e. the 0 value, be measured?



Interpretation of Annex 1 - Swissmedic publishes Q&A Document

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".



Severe GMP Violations in the Aseptic Area

Due to numerous and serious GMP violations in the aseptic area, the FDA issued a Warning Letter to an Indian sterile manufacturer in October. The areas affected include media fills, employee behaviour in the aseptic area, cleanroom & equipment design, environmental monitoring and CAPA.



Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops

Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.



High Conductivity in Pure Steam - possible Causes

The quality of pure steam is determined by its condensate. This has the same quality characteristics as WFI (Water For Injection). The purity of the steam is usually very high due to the phase transition from liquid to gaseous. Nevertheless, in individual cases there may be increased measured values in the test point conductivity and/or TOC. Read about the possible causes.



Specify Delta Ferrite in Welds?

The delta ferrite content indicates the proportion of magnetisable, body-centred structure of the iron atoms in the stainless steel. It has an influence on the material properties of the stainless steel, primarily on its corrosion resistance. But how should the content be specified in stainless steel for pharmaceutical equipment or welding seams?



New USP Chapter: Wetting Properties of Pharmaceutical Systems

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).



Changes in Testing for Nitrate and Endotoxins in pharmaceutical Waters in the European Pharmacopoeia

In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).



Serious GMP Violations in the Aseptic Area

The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.


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