GMP Trends and Analyses!

15.01.2017

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

15.01.2017

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

03.10.2016

GOOD DISTRIBUTION PRACTICE: DISTRIBUTION CONCEPTS AND LEGAL RELATIONSHIPS

According to the GDP Guidelines "Compliance with these Guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products". But what distribution concept are there, and what do the legal relationships look like for them? An overview. Please read more here

03.10.2016

IMPACT OF THE CHANGES TO THE EUROPEAN GMPs ON CLEANING VALIDATION - PART II

Part I of this article covered the important changes in the EU guidance on the cleaning validation and life cycle programme. Part II now provides answers to Frequently Asked Questions (FAQ) by pharmaceutical manufacturers. These questions were collected from American and European manufacturers over the last 18 months. Please read more here

03.10.2016

ICH Q7 GUIDE - QUESTIONS AND ANSWERS ON GMP FOR ACTIVE PHARMACEUTICAL INGREDIENTS

The ICH Q7 Q&A document provides clear indications, references and examples and is therefore a valuable aid in interpreting the requirements of the ICH Q7 Guideline. The APIC "ICH Q7 Q&A How to Document" additionally substantiates and facilitates the implementation in the every day practice. Please read more here

03.10.2016

CONSEQUENCES OF ANNEX 1 REVISION FOR INDUSTRY

At the Pharma Congress delegates from more than 25 nations benefit from the direct exchange in six conferences and in the large exhibition PharmaTechnica presenting over 80 exhibitors. At the past Congress a keynote also specifically covered the industry's expectations with regard to the Annex 1 to be revised. Please read more here

03.10.2016

PACKAGING UPDATE: REQUIREMENTS ON PACKAGING AND MATERIALS - PART I

Primary packaging for medicinal products requires special attention to possible interactions with the content as well as to the protection of the content and safety aspects during the following application. Great care is therefore necessary when choosing the materials for their manufacture or in the selection from offers already on the market. What regulatory specifications have to be considered is covered in part I of this article. Please read more here

04.04.2016

GMP UPDATE - WHAT'S NEW IN EUROPE?

In the past year authorities in the GMP environment announced a number of revised and also new requirements - as, e.g., Annex 21, concentrating on the import of medicinal products, or the FDA Quality Metrics Initiative. These requirements have now to be implemented. But what does this mean for industry? Please read more here

04.04.2016

IMPACT OF THE CHANGES TO THE EUROPEAN GMPs ON CLEANING VALIDATION - Part I

The avoidance of cross contaminations was one of the important subjects in the past years. A robust cleaning validation and the definition of health-oriented exposure limits were identified as effective measures against these cross contaminations. The EU GMP Guide requirements to this effect were modified respectively. Please read more here

04.04.2016

API SUMMIT - 18TH EUROPEAN ACTIVE INGREDIENTS' MANUFACTURERS MEETING

The APIC/CEFIC European Conference last November has shown once more, how important a constant communication and how fruitful an information and experience exchange between industry and authority representatives can be. Please read more here