GMP Trends and Analyses!

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

FDA/GMP TRENDS IN THE MANUFACT URE OF ASEPTIC AND SOLID DOSAGE FORMS

More than 70 lectures - mostly case studies from the pharmaceutical industry - as well as live demos and panel discussions were on the agenda of the well attended Pharma Congress end of March in Düsseldorf/Neuss. On the two Congress days everything revolved around current challenges, solution approaches and networking. Please read more here

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TABLETING PROBLEMS - CAUSES AND REMEDIES

How many pressing stations a tablet press has is frequently one of the first questions when evaluating new presses. In reality, the number of pressing stations used to manufacture a number of tablets rather has a subordinate meaning, though. Please read more here

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THE NEW CHANGES TO USP CHAPTERS FOR PARTICULATE MATTER GUIDANCE

The cGMPs merely state to exclude foreign matter and to minimize foreign particle content. The USP can provide further guidance with regard to definitions, methods, and limits for visible and subvisible particles, though. And this does not only apply to sterile injectable products, but also to biotherapeutic and ophthalmic products. Please read more here

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QbD AND PAT - CURRENT STAT US OF THE PHARMACE UTICAL INDUSTRY

Even after 10 years of PAT and QbD the industry's manufacturing sectors are still seen as failing to perform at manufacturing levels commensurate with society's current expectation. Despite PAT and QbD, current Good Manufacturing Practice and Good Manufacturing Performance are apparently two complete different things. Reason enough for a holistic view at both principles. Please read more here

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ACTIVE INGREDIENTS: SIDE EFFECTS CLEARLY WANTED

Discussions among the delegates of the 16th European API Conference past November in Madrid were quite vivid. The more this showed that there is a need for communication between the two sides - industry and authorities - as well as among themselves. Please read more here

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COMPLIANCE IN THE LAB: INFORMED PERSONNEL INDISPENSABLE

A good laboratory performance not only includes qualified equipment, validated processes and methods and corresponding systems for data processing and analysis. It also implicitly comprises personnel who is on top of current developments. For that reason a new Congress with six conferences and a large exhibition starts in November. Please read more here

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VISUAL INSPECTION OF PARENTERALS: CONTROL OF PARTICULATE MATTER

According to the pharmacopoeias the inspection of medicinal products for parenteral use has to be carried out in 100 % of the cases. Notwithstanding the requirements laid down in the pharmacopoeias and in Annex 1 there are still lots of open questions for manufacturers as various points are not described sufficiently. Please read more here

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THIRD PARTY GMP AUDITS: WHICH REPORTS CAN BE USED - WHICH CAN'T?

More and more organisations offer third party GMP audits of API manufacturers. Their acceptance is not at all clear, though. Now the European Medicines Agency's guidelines for the quality standards of an API audit report and the auditor qualification set the benchmark. Please read more here

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ICH Q10: IMPLEMENTATION THROUGH TOTAL PROCESS QUALITY IMPROVEMENT - 1

The concept for Total Process Quality Improvement (TPQI) has been developed for implementation of ICH Q10 as a Pharmaceutical Quality System. In the first part of this article you will get an overview of using Quality Cycles for ICH Q10 implementation. Please read more here

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CHALLENGE FOR THE QP: THE CHINESE MARKET

The increasing globalisation and the new legislation in terms of Good Distribution Practices (GDP) pose new challenges for companies in the pharmaceutical industry. The QP is among the first to experience this. Please read more here

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