STANDARDIZING QUALITY AGREEMENTS
One area that can benefit from a form of standardization 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 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 suppliers.1 The Society of Chemical Manufacturers and Affiliates, home to 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 for use by
drug manufacturers and suppliers when addressing raw materials, container closure/device components and packaging materials.3 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 template is intended to simplify and standardize the timeconsuming and
sometimes difficult process of negotiating quality agreements between biopharmaceutical or vaccine manufacturers and singleuse
system or component suppliers.
To discuss this topic further and provide an opportunity for users and suppliers to offer input, BioPharm and BPSA are collaborating to produce a web seminar on quality agreements for single-use manufacturing. The seminar is scheduled
for Wednesday Mar 2, 2011 (7 am PST, 10 am EST, 3 pm GMT, and 4 pm CET). For more details, see: http://biopharminternational.findpharma.com/webcasts/.
BPSA also will be hosting its inaugural International SingleUse Summit in Washington DC (Jul 27–29, 2011). The meeting will
focus on the future of biopharmaceutical manufacturing, with a specific emphasis on regulatory considerations and perspectives
on the effect of healthcare reform on drug markets. Innovations and market drivers affecting the singleuse industry also will
be discussed. More information is available at
http://www.bpsalliance.org/.
In my next column, I'll be reporting on global issues, as well as on the implementation of singleuse components, based on
participation as a speaker and panelist at several international meetings, including the ISPE Japan Sterile Products Processing
Community of Practice in Japan (Feb 17, 2011), the ISPE Aseptic Processing Seminar in Tampa, Florida (Feb 21–22, 2011), and
the IBC Biomanufacturing and SingleUse Systems Asia Conference in China (Mar 7–9, 2011).
In the interim, feel free to send me suggestions about topics, issues, and technology that affect your implementation of single-use
technology. I look forward to hearing from you.
Jerold Martin is senior VP of global scientific affairs, Biopharmaceuticals, Pall Life Sciences, Port Washington, NY, and chairman of the
Board and Technology Committee of the BioProcess Systems Alliance (BPSA), 516.801.9086, jerold_martin@pall.com
.
REFERENCES
1. US Food and Drug Administration. Guidance for industry. Cooperative manufacturing arrangements for licensed biologics.
Rockville, MD; 2008 Nov. Available from:
http://www.fda.gov/.
2. SOCMA BPTF. Manufacturer's quality agreement template. 2010 Apr. Available from:
http://www.socma.com/.
3. IPAC-RS. Quality agreement template toolkit. 2009 May. Available from:
http://www.ipacrs.com/.
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