GMP News - Pharmaceutical Technology

18.10.17

Warning Letter due to Deficiencies in Filling System Design/Testing Particulate Matter

Due to deficiencies in the design of the filling system as well as the testing for particulate matter, the FDA has issued a warning letter to an Italian manufacturer of sterile products in Rome. Read more about the deficiencies resulting in a Warning Letter. 

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04.10.17

The Role of Visual Inspection in the Release of Parenterals

According to the requirements of pharmacopoeias (e.g. EU or US), batches of sterile injectables must be 100% visually checked for defects. This test must be validated; because of its probabilistic nature, however, it is not 100% free from errors. How is this to be handled in the course of releasing batches?

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27.09.17

ECA Visual Inspection Group Chairman appointed to EDQM Expert Group

Dr Tobias Posset, Head of Production Support at Roche Diagnostics in Mannheim, Germany and chairman of the ECA Visual Inspection Group, was recently appointed into expert group 12 of the EDQM (European Directorate for the Quality of Medicines & Health Care). Amongst other things, this expert group develops recommendations for the revision of monographs concerning visual inspection. Learn more about Dr Posset's appointment to the EDQM Expert Group.

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20.09.17

Warning Letter to Indian API Manufacturer: Equipment Deficiencies

Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.

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06.09.17

FDA publishes Draft Guidance for Medical Gases

Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.

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30.08.17

EMA publishes final Version of Q&A Paper on Production of "cold" WFI

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.

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02.08.17

USP monograph <1790> "Visual Inspection of Injections" comes into force

The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st. Read more about the new Visual Inspections Monograph.

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12.07.17

What is GMP compliant Equipment Design?

It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.

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05.07.17

Glass Particles due to Delamination

The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.

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28.06.17

How often do HEPA Filters have to be changed?

In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are somtimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do HEPA filters need to be changed?

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21.06.17

Maintenance Cycles of pharmaceutical Water Systems

To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?

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14.06.17

Indian Sterile Manufacturer receives a second Warning Letter

In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.

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07.06.17

Visual Control by Doctor and Patient?

To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.

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31.05.17

Warning Letter to Pharmaceutical Manufacturer in Singapore due to Leaking Sterile Containers

A manufacturer of sterile ophthalmics in Singapore has recently received a Warning Letter of the US FDA. Container leaks and the associated risk of microbial contamination were the main points of criticism.

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17.05.17

FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.

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