10. August 2018
Making a case for GMP certification of an excipient manufacturer should be a straightforward exercise since the benefits appear so clear cut and regulatory guidance in the EU underscores the value of certification. Specifically, Chapter 3 of the EMA Guidance on formalised risk assessments to determine the appropriate GMP for a pharmaceutical excipient states that ‘certification of quality systems and/or GMP by the excipient manufacturer and the standards against which these have been granted...
13. July 2018
Historically, excipient manufacturers have relied on the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group's (PQG's) Joint IPEC-PQG Good Manufacturing Practices (GMP) Guide for Pharmaceutical Excipients [1]. The two organizations issued this guidance in 2006, and it was the product of a significant amount of work by IPEC's members. It provides a great baseline; the industry, however, has moved on.
14. January 2018
Data integrity continued to be a hot topic in the pharmaceutical industry through 2017. According to a recent analysis by GMP (good manufacturing practices) intelligence expert, Barbara Unger, approximately 65 percent of all US Food and Drug Administration (USFDA) warning letters issued in FY2017 (October 1, 2016 until September 30, 2017) included a data integrity component.
16. November 2017
Making a case for GMP certification of an excipient
manufacturer should be a straightforward
exercise since the benefits appear so clear cut and
regulatory guidance in the EU underscores the
value of certification. Specifically, Chapter 3 of the
EMA Guidance on formalized risk assessments to
determine the appropriate GMP for a pharmaceutical
excipient states that “certification of quality systems
and/or GMP by the excipient manufacturer and the
standards against which these have been granted...
31. May 2017
EXCiPACT asbl is delighted to announce that the Ashland Speciality Ingredients site in Doel, Belgium has recently been awarded an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies. The Certificate demonstrates that the Ashland Speciality Ingredients (ASI) site in Doel, Belgium, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the production of...
15. January 2017
EudraGMDP is the name for the Union database referred to in article 111(6) of Directive 2001/83/EC and article 80(6) of Directive 2001/82/EC. It contains the following information: Manufacturing and import authorisations Good Manufacturing Practice (GMP) certificates Statements of non-compliance with GMP GMP inspection planning in third countries In addition the following new information is required in the database for the first time in 2013. As data transfer from national systems can be...
22. September 2016
Abstract: Background: In this era of evolution, quality and safety of pharmaceutical dosage forms have been given a prime importance. In this context, a detailed knowledge about physical and chemical properties of excipients is not sufficient, but information about safety and regulatory status of these materials is now essential to know. The present work will be beneficial to focus more on the safety, quality and stability of pharmaceutical product. Objective: Study of regulatory mechanism for...
05. July 2016
NEWS RELEASE - Brussels, 5th July, 2016 The Board of EXCiPACT asbl is pleased to announce that, as required by the rules of the independent EXCiPACT Certification Scheme for manufacturers and distributors of pharmaceutical grade excipients operational since 2013, the triennial reregistration of the Scheme’s Certifying Bodies, Auditors and the recertification of Certificate Holders, has successfully begun.
05. July 2016
Kaat Bracquiné, quality and regulatory affairs, Capsugel explains how to achieve compliance with the new EU guidelines for excipient GMPs. Last year, the European Union published new guidelines (2015/C 95/02) that require the pharmaceutical industry to demonstrate appropriate excipient Good Manufacturing Practices (GMPs) through a formalised risk assessment. As of the implementation deadline in March 2016, pharmaceutical companies should have conducted these formalised risk assessments and...
09. May 2016
Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the...