GMP Trends and Analyses!

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

GMP UPDATE 2016/2017 – WHAT IS NEW IN THE EU – PART II

Last December, the webinar GMP Update summarized the latest "innovations" and "changes" in the GMP environment. In part II of this article, you will find out more about the developments in clinical trials, water for injection purposes, process validation for biotechnological products, ATMPs or data integrity in the current year. Please read more here

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DATA GOVERNANCE: ROLES AND RESPONSIBILITIES

In the past two years, the issue of data integrity has increasingly moved into the focus of international authorities. Because in addition to the product quality of the medicinal product, the integrity of the data documenting its quality is one of the main GMP requirements. But who has what responsibilities in the company? Please read more here

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WARNING LETTERS: DRAMATIC INCREASE TO CHINESE COMPANIES

The systematic evaluation of the Warning Letters sent by the US FDA to pharmaceutical companies or API manufacturers in recent years shows that the agency's focus is shifting again and again. The evaluation of the "Blue Letters" for the year 2016 revealed a surprise in several respects. Please read more here

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CONFERENCE REPORT: QUALITY MANAGEMENT AND DATA INTEGRITY IN API PRODUCTION

In the production of active ingredients, Part II of the EU GMP Guideline and the Guideline Q7 of the International Council for Harmonization (ICH) form the basis of the legal requirements. Specific aspects of quality management and responsibilities are also defined in the ICH Q10 Guideline. Still, inspectors keep on finding deficiencies in the QM system in inspections. Please read more here

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PHARMA CONGRESS: INNOVATIONS IN PRODUCTION AND PROCESS TECHNOLOGY

The largest pharmaceutical industry get-together of its kind in Europe is coming up end of March again. In ten conferences, delegates from more than 20 countries will once again have the opportunity to learn from case studies presenting challenges from everyday practice and appropriate solution approaches. The meeting will be accompanied by the exhibition PharmaTechnica with nearly 90 exhibitors. Please read more here

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TRENDS IN LABORATORY INFORMATICS

Just like almost anywhere else, informatics is the normality in lab operations. Data intensive analytics create gapless knowledge management systems also facilitating the cross-sectoral collaboration. The trends in data integrity, security and in the current regulatory requirements were in the centre of interest during the lab informatics updates at the PharmaLab Congresses of the last two years. Please read more here

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CURRENT DEVELOPMENTS IN GMP COMPLIANCE

Every two years the European GMP Conference sheds some light on the currently discussed issues in GMP compliance. The forthcoming 7th edition of the conference in May/June will concentrate on the subjects harmonisation in the GMP environment, Quality Metrics, Data Integrity and statistical/reduced sampling as well on the developments in some of the ECA's Working and Interest Groups. Please read more here

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GMP UPDATE 2016/2017 - WHAT IS NEW IN THE EU - PART I

GMP UPDATE 2016/2017 - WHAT IS NEW IN THE EU - PART I

Even though the GMP world may not have turned as fast as in the previous years, the past year still was not less interesting. What has to be reported in terms of "novelties" and "changes" is summarized in the GMP Update. Please read more here

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PACKAGING UPDATE: REQUIREMENTS ON PACKAGING AND MATERIALS - PART II

Part I of this article described the regulatory requirements that need to be considered when choosing the materials for the manufacture of primary packaging or when selecting from offers already on the market. Part II now concentrates on Extractables & Leachables, Container-Closure Integrity as well as on the requirements for sterile packaging and on defect evaluation lists. Please read more here

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