Standardising Quality Agreements
One area that can benefit from a form of standardisation is Quality Agreements. In a recent editorial I wrote for PTE (October
2010; available at
http://www.pharmtech.com/jmartin), I discussed a new initiative by the BPSA to develop a Quality Agreement Template for singleuse suppliers and users. The
FDA has provided guidance on establishing quality agreements with contract manufacturers of licensed biologics, and drug manufacturers
are seeking similar agreements with all their suppliers, including equipment.1 The Society of Chemical Manufacturers and Affiliates (SOCMA), home to the BPSA, has a Bulk Pharmaceuticals Task Force that
has developed a Template for Quality Agreements related to the manufacture and release of substances regulated by the FDA.2 A similar template has been developed by the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS)
for use by drug manufacturers and suppliers when addressing raw materials, container closure/device components and packaging
materials.3 The BPSA, through its Singleuse System Quality Agreement Template Task Force, is adapting the content of these guides to
develop a template specific to singleuse manufacturing. This is intended to simplify and standardise the otherwise timeconsuming
and sometimes difficult process of negotiating quality agreements between biopharm or vaccine manufacturers and singleuse
system or component suppliers.
To further discuss this topic and provide opportunity for users and suppliers to provide input, BPhI and the BPSA are collaborating
to produce a web seminar on Quality Agreements for single use manufacturing. The seminar is scheduled for Wednesday 2 March
(7 am PST; 10 am EST; 3 pm GMT, 4 pm CET). For more details, see: http://biopharminternational.findpharma.com/webcasts
The BPSA will also be hosting its inaugural International SingleUse Summit (ISUS) in Washington DC (USA; 27–29 July). The
meeting will focus on the future of biopharmaceutical manufacturing, with a specific emphasis on regulatory considerations
and perspectives on the impact of healthcare reform on drug markets. Innovations and market drivers affecting the singleuse
Industry will also be discussed. More information is available at
In my next column, I'll be reporting on global issues, as well as the implementation of singleuse based on participation as
a speaker and panelist at several international meetings including the ISPE Japan Sterile Products Processing Community of
Practice Meeting in Japan (17 February), the ISPE Aseptic Processing Seminar in Tampa (Florida, USA; 21–22 February) and the
IBC Biomanufacturing and SingleUse Systems Asia Conference in China (7–9 March).
In the interim, feel free to send me suggestions on topics, issues and technology that impact your implementation of single-use.
I look forward to hearing from you. firstname.lastname@example.org
Jerold Martin is Senior VP of Global Scientific Affairs at Pall Life Sciences, Biopharmaceuticals Group, and Chairman of the Board and Technology
Committee of the BioProcess Systems Alliance (BPSA). He is also a member of Pharmaceutical Technology Europe's Editorial Advisory Board. email@example.com
1. FDA, Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (November 2008).
2. SOCMA BPTF, Manufacturer's Quality Agreement Template (April, 2010).
3. IPAC-RS, Quality Agreement Template Toolkit (May, 2009). http://ipacrs.com