News

Twelve Complete In-Person Excipient GMP Compliance Workshop

05 October 2023 – Arlington, Virginia

IPEC-Americas hosted twelve representatives of excipient manufacturers, distributers, and users at their US (Arlington, Virginia) headquarters for an in-person, 3-day excipient GMP compliance workshop. The workshop's instructors were Jeffrey Brambora, BlackTower Quality Group's Principal GMP Consultant and IPEC-Americas Excipient Learning Lab's Irwin Silverstein; Brambora presented remotely from Basel, Switzerland.

Beyond the information conveyed during the workshop, participants appreciated Brambora and Silverstein for the advice and coaching that they provided, as well as the learning they facilitated. One highly experienced participant acknowledging the pair as "two of the leading (excipient GMP) experts in the world."

For the safety and efficacy of pharmaceutical products, compliance with excipient GMP is essential to the manufacture, distribution, and use of excipients. The Excipient GMP Compliance Workshop included analyzing essential elements and expectations related to excipient good manufacturing practice. The workshop reviewed the EXCiPACT Excipient GMP Certification scheme and the requirements of the NSF/IPEC/ANSI 363-2019 excipient GMP standard.

Visit the IPEC-Americas website for more information about the safe and effective production and use of excipients.

In-Person Excipient GMP Compliance Workshop scheduled

12 May 2023 – Arlington, Virginia

IPEC-Americas Excipient Learning Lab announces that its next Excipient GMP Compliance Workshop is scheduled for 03-05 October 2023. This workshop will be presented at the IPEC-Americas headquarters in Arlington, Virginia and will be facilitated by Irwin Silverstein, IPEC-Americas Excipient Learning Lab, and Jeffrey Brambora, BlackTower Quality Group. 

Compliance with excipient GMP/GDP is important to everyone (not just auditors) involved in the manufacture, distribution or use of excipients. This workshop includes analyzing essential elements and expectations related to excipient good manufacturing practice and good distribution practices for materials intended for use in pharmaceuticals or dietary supplements. This workshop reviews the EXCiPACT Excipient GMP Certification scheme and the requirements of the updated NSF/IPEC/ANSI 363-2019 standard.

Visit the IPEC-Americas website for more information or to register for the workshop.

More than 175 global participants at the IPEC Federation Webinar 

03 November 2022 – Brussels, Belgium

IPEC Federation held a free, members-only webinar on Thursday, 03 November 2022 to answer questions about the new IPEC-PQG GMP Guide 2022. Jeffrey Brambora, BlackTower Quality Group's Principal GMP Consultant summarized the changes made to the guide and answered questions submitted by IPEC members from around the world. 

Participants as well as registered members who could not attend the live event will have access to the recorded webinar, but only for a limited time.

Free IPEC Federation Webinar discussing the 2022 IPEC-PQG GMP Guide

06 October 2022 – Brussels, Belgium

IPEC Federation is sponsoring a free webinar on Thursday, 03 November 2022 at 13:00-14:00 GMT (UTC+0). The members-only event will be presented by Jeffrey Brambora, BlackTower Quality Group's Principal GMP Consultant. The topic of the webinar is to introduce the new IPEC-PQG GMP Guide 2022 and to answer questions about the guide submitted by IPEC members. 

IPEC Federation is now accepting questions to be discussed during the webinar. Questions can be emailed to the IPEC Federation Secretariat until 17 October 2022 at info@ipec-federation.org.

Visit the event page for more information or to register for the free, members-only webinar.

IPEC Europe Excipient Conference 2022 keynote address

27 September 2022 – Frankfurt, Germany

Jeffrey Brambora, BlackTower Quality Group's Principal GMP Consultant, presented the keynote address at IPEC Europe Excipient Conference 2022. The address, entitled “IPEC-PQG GMP Guide 2022: what’s new and what’s not”, helped conference attendees understand:

• key changes from the 2017 GMP guide;

• the structure of the 2022 GMP guide, which was published only the day before the conference began;

• how to understand and implement the guidance given in the 2022 GMP guide.

The conference took place in Frankfurt, Germany and was attended by leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the United States Pharmacopoeia (USP), as well as excipient and pharmaceutical professionals coming from four continents and working in:

• development, manufacture, and quality;

• distribution and sales;

• supplier qualification.

Brambora’s speech was simultaneously delivered by Adrian Bone, Senior Advisor to IPEC Europe, to attendees of the Making Pharmaceuticals 2022 conference in Dublin, Ireland.

A powerful voice in Europe since 1992, the International Pharmaceutical Excipients Council Europe (in short, IPEC Europe) brings producers, distributors and users of pharmaceutical excipients together in one place. IPEC Europe provides a welcoming environment to share experiences and knowledge, to learn, and to lead the future of excipients. Visit the IPEC Europe website for more information or to become a member.

Commendations for IPEC-PQG GMP Guide 2022 efforts

26 September 2022 – Brussels, Belgium

Dr. Amina Faham, the Chair of International Pharmaceutical Excipients Council (IPEC) Europe, extended commendations to Jeffrey Brambora, Principle GMP Consultant with BlackTower Quality Group for his “exceptional commitment and outstanding efforts to revise one of IPEC’s most important publications, namely the IPEC-PQG GMP Guide”. By defining current good manufacturing practices for excipients, the 2022 GMP guide continues IPEC’s more than 25 year history of bringing value to its members and, ultimately, safety to patients.

This fifth version of the IPEC-PQG GMP Guide was co-published on 26 September 2022 by IPEC Federation and the Pharmaceutical Quality Group. The document, which is nearly four-times longer than the previous version, is the culmination of a global team effort that lasted five years.

The 2022 version of the IPEC-PQG GMP Guide is now aligned with the requirements of ISO 9001:2015, EXCiPACT® GMP, and NSF/IPEC/ANSI 363. It will be used by excipient manufacturers to develop and improve their quality management systems, and by excipient users and health authorities to evaluate the conformity and adequacy of these management systems.

The new GMP guide is now applicable for the manufacture of all excipients, including excipients used in specialist applications such as parenteral and inhalation formulations. Additionally, the guide contains more explanatory notes than any other IPEC guide. These notes will assist the reader interpret the principles of excipient GMP and can help excipient manufacturers implement a suitable quality management system.

The IPEC-PQG GMP Guide 2022 is available without cost to IPEC and PQG members through their respective websites, ipec-federation.org and pqg.org. Non-members can access the document at the end of a three month embargo.

Newest co-opted member of IPEC Europe

1 August 2022 - Brussels, Belgium

BlackTower Quality Group's Principle GMP Consultant, Jeffrey Brambora, was unanimously approved by the IPEC Europe Board of Directors to become a co-opted member of IPEC Europe. 

A powerful voice in Europe since 1992, the International Pharmaceutical Excipients Council Europe (in short, IPEC Europe) brings producers, distributors and users of pharmaceutical excipients together in one place. IPEC Europe provides a welcoming environment to share experiences and knowledge, to learn, and to lead the future of excipients.

The members of IPEC Europe engage in an open dialogue with one clear mission: quality excipients for medicines. As a member of IPEC Federation, IPEC Europe develops and promotes harmonized guidelines to create the appropriate quality and functionality standards to improve patient safety. 

IPEC Europe's internationally accepted guidelines give recognition to the value of its collaborative efforts.

For more information about IPEC Europe or to become a member, visit the IPEC Europe website or call +32 (0) 2 213 74 40.