GMP Trends and Analyses!

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

CONTI MANUFACTURING - THE CONTINUOUS MANUFACTURE OF TABLETS

CONTI MANUFACTURING - THE CONTINUOUS MANUFACTURE OF TABLETS

Systems for continuous manufacturing can be very compact, integrate many individual steps, thus ensuring fast turnaround times and reducing production costs. While such systems have already prevailed in the production of chemicals and foods, batch processes are still widely used in the pharmaceutical industry. The continuous manufacture of tablets is still in its infancy. Please read more here

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CLEANING AND DISINFECTION - A RISK BASED VS AN ARBITRAY APPROACH - PART I

CLEANING AND DISINFECTION - A RISK BASED VS AN ARBITRAY APPROACH - PART I

In the manufacture of (bio) pharmaceuticals and medical devices, the cleaning and control of microbiological contamination are critical areas. Therefore, the disinfectants used, the frequency of their use and the rotation of (one or more) disinfectants together with a sporicidal agent should be scientifically justified by a formal microbiological risk assessment (MRA). Please read more here

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SERIALISATION: WHAT IS THE QUALIFIED PERSON'S (QP) ROLE?

SERIALISATION: WHAT IS THE QUALIFIED PERSON'S (QP) ROLE?

Until 9 February 2019, companies in the EU will have time to implement the safety features defined by the Delegated Act (Commission Delegated Regulation (EU) 2016/161) to verify the authenticity of medicinal products. So, what activities and systems need to be developed and implemented at a manufacturing site? And what role does the Qualified Person (QP) play in the tasks? Please read more here

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ANALYSIS OF BIOPHARMACEUTICALS – AUTHORITY EXPECTATIONS

ANALYSIS OF BIOPHARMACEUTICALS – AUTHORITY EXPECTATIONS

The term "biopharmaceuticals" comprises a very heterogeneous group of products - ranging from monoclonal antibodies, hormones, enzymes, plasma products and ATMPs to biosimilars. This results in several new challenges for manufacturers as well as for authorities to ensure the required safety and quality of the products in accordance with Directive 2001/83/EC. So what do the authorities expect? Please read more here

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CONFERENCE REPORT: TECHNICAL AND REGULATORY DEVELOPMENTS IN THE PHARMACEUTICAL INDUSTRY

CONFERENCE REPORT: TECHNICAL AND REGULATORY DEVELOPMENTS IN THE PHARMACEUTICAL INDUSTRY

In the 19th edition of the Pharma Congress end of March, lectures once again discussed the current regulatory developments and possible consequences for sterile medicinal products and their GMP-compliant production. According to the Congress' motto "Operators reporting for Operators", the speakers presented the current trends through many case studies. Please read more here

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CYBER SECURITY - IS IT TIME TO RECONSIDER THE IT LANDSCAPE AND THE DESIGN OF INDUSTRIAL COMPUTERISED EQUIPMENT?

CYBER SECURITY - IS IT TIME TO RECONSIDER THE IT LANDSCAPE AND THE DESIGN OF INDUSTRIAL COMPUTERISED EQUIPMENT?

WannaCry, Petya, GoldenEye ... for some years now malware has been threatening the IT infrastructure of companies worldwide. The latest attacks have already caused major damages - even at some global players. The fact that they had only a "limited" impact and did not completely paralyse entire companies was due to a few "design failures". The question is, therefore, whether the IT infrastructure has to be reconsidered to face the growing IT threats? Please read more here

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QUALITY MANAGEMENT AND DATA INTEGRITY IN API PRODUCTION

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

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

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

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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