in-PharmaTechnologist.com's round-up of developments in pharmaceutical manufacturing features news of SAFC’s new highly potent API plant, ISPE’s Facility of the Year Awards and Israel’s proposed entry into PIC/S.
SAFC building new HP-API facility
SAFC Pharma is to build a new 45,000 sq ft manufacturing facility in Verona, USA, for the manufacture of highly potent active pharmaceutical ingredients (API).
Construction is due to start on October 1, with SAFC hoping to have the plant finished by late 2009 and start production early the next year.
The new plant is located 15 minutes away from SAFC’s existing facility in Verona’s University Research Park. SAFC expanded this plant by 38,000 sq ft just 2 years ago but now needs additional space to produce larger batches of APIs.
Initially the new facility will run 24 hours a day, five days a week. After the site is operational for 12 months SAFC has said production could be increased to run 7 days a week.
When production starts the facility will employ around 50 people but this could increase to 80 over the next five years. Plans for the facility include plots for two other buildings that may be constructed in the future.
ISPE Facility of the Year Awards
ISPE is seeking submissions for its 2009 Facility of the Year Awards (FOYA), which seeks to recognise and spread innovative approaches to many aspects of manufacturing plant design.
Newly constructed or renovated facilities are eligible to apply and awards will be given to plants that excel in the following categories; process innovation, project execution, equipment innovation, facility integration, sustainability and operational excellence.
Clive Mullins, chairman of the Facility of the Year Awards committee, said: “Receiving recognition as a Facility of the Year Award winner generates unsurpassed opportunities for manufacturers and their key supporting organisations to showcase their ingenuity.
“This program really motivates professionals in the pharmaceutical industry to share best practices within the global community.”
Since its inception five years ago FOYA has attracted entries from over 20 countries and has awarded facilities from nine different nations.
ISPE recently re-designed its website based on feedback from pharmaceutical manufacturers, with the association believing the new site can “serve our membership better”.
Israel closing in on PIC/S membership
Israel is close to being admitted into the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S).
The news follows joint inspections by the Israeli Health Ministry and PIC/S on behalf of the European Union. Israel is hoping that gaining entry to the PIC/S will increase exports of medications and raise manufacturing standards.
PIC/S are international bodies that seek to foster constructive cooperation between pharmaceutical manufacturers to ensure adherence to good manufacturing practices (GMP). If admitted, Israel will become the 35 nation in the PIC/S.