GMP News - Pharmaceutical Technology

04.03.15

Causes for Weight Variations during Tableting

Weight variations of the tablets produced is a relatively common problem of the tableting process. Read more about the Causes for Weight Variations during Tableting.

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12.02.15

EU GMP Annex 1: EMA plans the Revision of the Sterile Guide

At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. Read more.

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12.02.15

EU issues new Version of GMP Guide Chapters 3 and 5

The EU has re-published the recently revised Chapters 3 and 5 and has made modifications regarding the coming into effect of the introduction of the toxicological evaluation of products in multipurpose facilities. Read on.

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04.02.15

USP Chapter <1790> Visual Inspection of Injections published

The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1) for commenting. Read on.

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10.12.14

Best Practice Paper on Visual Inspection now available for download

After the transition of the ECA Visual Inspection group from a working to an interest group, it is now possible to join the group for free. Group members have access to the full site content including the download of the best practice paper on visual inspection. Read more.

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03.12.14

Warning Letter: Deficiencies in Visual Inspection

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals justified by deficiencies in the visual inspection of vials. Read more here.

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26.11.14

Shared and Dedicated Facilities: EMA publishes final Guideline on Setting health based exposure limits (PDEs)

The EMA has now published the long awaited final version of the Guideline which sets the exposure limits of products manufactured in so-called shared facilities. Read more here.

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26.11.14

New Q&A concerning Visual Inspection

The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL inspections. To find some of these questions and answers by Dr. Tobias Posset (Head of Production Support at Roche Diagnostics) please read here.

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29.10.14

Statistical Analysis of FDA's Inspection Findings

The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. Read more here.

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24.09.14

WHO publishes New Version of the Draft on "Hold-Time" Studies

In August, the WHO published the third revision of the draft guidance document on the design of hold-time studies. In many parts, the new version has become much clearer than the previous version. Read more.

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23.09.14

Is there something like Authorities' approved production equipment?

Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. Get the answer here.

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10.09.14

Commentary Regarding new USP Chapters <787> and <1787> for Particulate Matter Guidance

There are new chapters in the USP regarding testing of subvisible particles. Chapter Subvisible Particulate Matter in Therapeutic Protein Injections <787>  became official August 1, 2014. The informational chapter <1787> was developed to support chapter <787> and will be published in USP 38 in November and become official on May 1, 2015. Read more.

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03.09.14

EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5

The EU Commission has published the long-awaited, revised chapters 3 and 5 of the EU GMP Guide. The change focuses on the prevention of cross-contamination as well as on the statement concerning the need for dedicated facilities. Continue reading.

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03.09.14

Questions and Answers on the Topic "Pharmaceutical Water"

In the following News, you will find questions on pharmaceutical water preparation and distribution frequently asked during our courses, as well as their respective answers. Read more here.

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27.08.14

Questions and Answers on the Topic "Visual Inspection"

On the topic of visual inspection of parenterals there are always questions on how to implement in practice. Some compiled Q&As are supposed to support you in this implementation. Find out more.

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