GMP NEWS 2016

Practical Implementation of the Control of Elemental Impurities: EMA's new Guideline Draft

One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation of ICH Q3D. Read more here about what is expected in a marketing authorisation application or in an application for a CEP with regard to risk assessment and the control of elemental impurities in APIs and medicinal products.

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Elaboration of New USP General Chapter <1220> - Analytical Procedure Lifecycle - announced

On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> regarding life cycle management of analytical methods. Read more about the new general chapter  <1220> "The Analytical Procedure Lifecycle".

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Storage and Transport: New USP Chapter for Investigational Drug Products

The USP has proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters, focusing on investigational drug products.

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Example by Inspectorate for Handling Temperature Excursions

In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU.

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GDP: What is a Pre-Wholesaler?

The definition for "pre-wholesale" is neither present in the EU GDP guidelines nor in the GMP requirements from Eudralex. However, this concept does exist and some things have to be considered.

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Drafts of revised USP plastic packaging chapters <661.1> and <661.2>: removal of the biological reactivity test for oral and topical dosage forms

In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.

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EMA reviews Medicines manufactured at U.S. Company

Following the issuance of two Non-Compliance Reports for two sites of the US based company, EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA.

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WHO publishes Qualification Guideline for Comment

The WHO is currently revising its validation guidelines and has recently published a superordinate umbrella guideline. Now, an independent chapter on qualification was published for comment.

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Storage and Transport: New USP Chapter for Investigational Drug Products

The USP has proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters, focusing on investigational drug products.

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FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on "Quality attribute considerations for chewable tablets". Read more about the critical quality attributes recommended for chewable tablets.

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FDA issues new Draft Guidance on Elemental Impurities

The recently issued FDA Guideline on Elemental Impurities as a draft describes the procedure for controlling elemental impurities for medicinal products with and without official USP monograph. Read in what cases the FDA expects the fulfilment of the requirements of the Guideline ICH Q3D respectively of the general USP Chapter <232> und <233>.

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WHO publishes Draft of an Umbrella Guideline on Process Validation

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.

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Italian Manufacturer receives FDA Warning Letter for Hygiene Issues

On 20 May 2016, the U.S. American FDA published a Warning Letter for major hygiene issues in aseptic manufacturing. Find out more about the Warning Letter issued for the Italian manufacturer Corden Pharma Latina S.p.A.

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Important FDA Guideline on Combination Products published

During the development of combination products, "Human Factors Studies" have been gaining importance with regard to design and development. After the FDA had received many requests on how to perform such studies, a new Draft Guidance on Human Factors Studies in Combination Product Design and Development has been elaborated.

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Which Deficiencies in the Quality System of Medical Devices Manufacturers were found by the FDA in 2015?

The ECA regularly publishes statistics of Warning Letters issued by the FDA to medical devices manufacturers. For some time, the FDA has also been publishing statistics regarding deficiencies with regard to the Quality System of medical devices manufacturers. What were FDA's findings in 2015?

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FDA publishes Technical Guide on Quality Metrics

The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn't been finalised yet. Read more about the Technical Quality Metrics Guide.

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Annex 16: How a QP should handle unexpected Deviations

In a recent blog of the MHRA, the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations.

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FDA Warning Letter to pharmaceutical manufacturer in Taiwan who owns ISO Certificates

Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.

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EU issues Non-Compliance Reports for US Company

EU Non-Compliance Reports for two sites of a US based company have been published leading to a withdrawal of the GMP Certificate and a stop of supplies into the EU.

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New Case of Counterfeits Suspected at German Company

Again, the company Orifarm must recall batches because of suspicion of falsification. The company located in Leverkusen, Germany has received information from the Greek Competent Authority according to which falsified blisters emerged. Read more about the current case of counterfeits.

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