Another great learning experience resulted from dinner last night with Peter Dossing and Tom Diederich of Emerson Process…Now, pharma manufacturing is taking center stage–with a boost from the FDA–and they are ready to automate and study process improvement techniques.
Being the curious sort, I called Tom to catch up on some of the conversation. He described how pharmaceutical and biotech manufacturers, unlike most other industries live with extremely manual paper-based systems to meet the regulatory requirements of governmental agencies. These regulations are designed to prove repeatability, that what is being made today is the same as what was being made yesterday. As consumers, we expect the medications we receive to be right, not just somewhat close to right. The paperwork created to document that the correct procedures have been followed is as important as the products being produced.
Unfortunately getting things right the first time is extremely cumbersome and difficult with manual, paper-based operating procedures. Tom relayed an example of one pharmaceutical manufacturer getting things right the first time–less than 5% of the time. For this manufacturer, it meant spending 30,000 man-hours or 15 man-years annually checking, reviewing and recirculating documents before batches of the product could be released for sale.
A simple example – imagine an operator having to manually add 2 cc’s of an additive to a running batch. Today, he does it, signs off on a paper saying he’s done it, hands to his boss who signs off, who hands off to his boss to sign off according to the proscribed operating procedures, etc.
The questions this simple procedural example prompts are numerous: Was he trained properly to do this? Is his training current/expired? Was the measuring device calibrated? Did he add the correct additive? Did the additive have temp or light exposure limits/specs? Were those specs/limits exceeded? All these and much more must be checked, again to the standard operating procedures.
The Emerson Life Sciences industry team is working with pharmaceutical and biotech manufacturers and sharing their expertise in studying processes to see where they can be streamlined through work practice changes or through having automation and/or compliance management solutions applied. Many of these manual procedures and documentation steps like checking the training records, bar code scanning for equipment and material tracking, weighing, and dispensing additives, and electronic signatures, can be automated and collected as part of a complete batch record. This greatly speeds up the release of the manufactured product and significantly reduces the number of errors associated with manual data entry; both of which directly impact the bottom line.
The U.S. Food and Drug Administration’s Process Analytical Technologies (PAT) initiative is a catalyst for Life Sciences manufacturers to re-examine their current practices and look at ways to build product quality and consistency into the processes and procedures instead of fixing it after the fact. Some of these operational excellence practices are now being adopted in partnership between manufacturers and Emerson Life Sciences experts with significant results.