For any journalist, few things are more dull to follow than the snail-like progress of technical, IT or quality standards. Yet it's standards that slowly transform entire industries, and will change the way that drug manufacturers use IT and automation. It's standards that promise to change the way that drug companies perform quality assessment and control, and handle their documentation in the future. At the World Batch Forum in Atlanta, I saw how WBF members from around the world and their colleagues at ISA, CSIA, and MESA are working to develop standards for batch and continuous manufacturing, and for plant control system and IT security. Are any of your companies installing electronic notebooks for quality or R&D laboratories, or for manufacturing? Even if you're an operator, a chemist or a research scientist involved, in some way, in these efforts, you should read up on S88 and S95. (For indepth information, check Controlglobal.com or the tongue-in-cheek BatchControl site.) The fact is that leading biopharmaceutical and pharmaceutical companies are applying the principles behind these standards, every day, to simplify plant design, startup and validation. Genentech is a great example. Open control just saved the company nearly $5 million in automation implementation costs alone at its Vacaville, Calif. plant. Pfizer is another company that applies these concepts every day, as do a number of other leading drug companies. But there appear to be many more organizations that aren't aware of this work, much less engaged in it. If your company isn't looking at how to apply these standards, it should be---or it should be working with a systems integrator who knows them well. WBF's meeting also underscored, for me, the fact that it's people who drive standards---those who take time out of their own grinding professional lives and precious, and dwindling family time, to meet with others, discuss technical problems and issues, and drive change, slowly and gradually. So here's a toast to pharma's standards-setters, wherever they may be, including:
- ASTM's E-55 committee and its various subcommittees, which are trying to establish common ground for pharmaceutical process analytical technologies (PAT), and, in the process, levelling the playing field, and opening up dialogue between generics and name-brand manufacturers, FDA and industry.
- USP, which has just opened a new center in Hyderabad, India, to set standards there and verify the quality of dietary supplements, APIs and excipients.
- The ICH Expert Working Group, and the Pharmacopeial Discussion Group, now working on harmonizing global regulatory requirements, a long and difficult road.
- The IFPAC Vendor Certification program, setting standards for equipment used in PAT and for quality control.