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

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

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

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