GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

NEW STRATEGIES: THE FIGHT AGAINST COUNTERFEIT MEDICINES

The latest developments in the fight against counterfeit medicines were in the centre of attention at the ECA Conference "Strategies against Counterfeit Medicines" in Würzburg, Germany, last spring. Please read more here

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BIO PRODUCTION FORUM: BRIDGING RESEARCH AND INDUSTRY

In the past years the Bio Production Forum has been concentrating on taking a close look at the last stages of the development up to the production of biopharmaceutical products. As in the past years the conference this year again initiated the discussion of current regulatory developments and contributed to the understanding of the latest trends. Please read more here

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POINT OF VIEW: CHANGES IN THE CHAPTER ON TESTING NON-STERILE DOSAGE FORMS

What are the most important changes in the first revision of the chapter on testing non-sterile dosage forms and the proposed acceptance criteria and what do they actually mean? Please read more here

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IMPACT: THE MONOCYTE-ACTIVATION TEST (MAT) REDUCES THE RISK OF PYROGENICITY

In April 2010 the Monocyte Activation Test (MAT ) for the proof of pyrogenic substances has been included in the European Pharmacopoeia. This opens the chance for enormous progress with regard to ensuring that pharmaceutical products are free of pyrogenicity. Please read more here

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THE NEW PHARMA PACKAGE: FAR REACHING CONSEQUENCES FOR THE GMP ENVIRONMENT

The most important of three legislative proposals for the GMP environment by the European Commission is Part 3, dealing with combating counterfeit medicines as well as illegal distribution of medicinal products. Please read more here

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PAEDIATRICS: CONSEQUENCES OF THE EU REGULATION

The Regulation on Medicinal Products for Paediatric Use has been effective since December 2006. And this regulation is mandatory for all pharmaceutical companies developing new products. Please read more here

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WEIGHTING: ADVANTAGES AND DISADVANTAGES OF ELECTRONIC BATCH RECORDS

The appropriate electronic system can not only help to better save and secure data but also to generate them automatically, integrate them into the batch record or even to control processes completely. Please read more here

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GAMP®5: COMPUTER SYSTEM VALIDATION IS UNDERGOING CHANGE

The processes recommended in the new Guide require a new way of thinking - especially in the quality assurance units of pharmaceutical manufacturers. Please read more here

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CONTROVERSIAL DISCUSSION: REQUIREMENTS OF ANNEX 1 CRIMPING / CAPPING

The requirements defined in the Annex 1 are still being discussed extensively. Now a PIC/S document may help companies to better interpret the requirements. Please read more here

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REVIEW: THE 12th EUROPEAN CONFERENCE ON ACTIVE PHARMACEUTICAL INGREDIENTS

Last November European API manufacturers and regulating authorities met in Venice, Italy, to discuss current GMP topics and regulatory issues. The openness on both sides clearly contributed to a further mutual understanding. Please read more here

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