Issue link: https://www.e-digitaleditions.com/i/626800
First, identify the regulatory requirements you must meet. Next, find out how the equipment and sorbent system you're considering meets those requirements and your com- pany's own quality standards. Questions may include: • Are the materials that contact the sorbent sachet or can- ister FDA compliant? • Do all sorbent products have a Type III Drug Master File? • Does the dispensing equipment offer first-in/first-out (FIFO) control? • Are the sorbents manufactured in a facility that complies with ISO 9001 and GMP, especially 21 CFR parts 210 and 211? While it's easy to see how most of these criteria affect quality, the importance of FIFO is sometimes overlooked. FIFO operation is prudent because it minimizes the sorbents' exposure and thus the loss of sorbent capacity (quality). A good way to ensure FIFO operation is to use dual hoppers and alternate running them. That ensures continuous opera- tion. It's also more efficient than using a single feed bowl where fresh sorbents mix with old ones. That could leave old sorbents in the bowl too long and/or require you to run the bowl empty and then pause production to refill it. Traceability and the ability to bracket a potential issue are also part of a comprehensive quality management sys- tem. If you can capture and transmit data directly into a SCADA-based quality system, so much the better. That makes information immediately available. In the case of sorbent dispensers, seek equipment that can transmit data—including lot number, manufacture date, and quantity, for example—from the packet spool to the dispenser. That information becomes a powerful tool when quality is questioned, because it shows whether the finished products were packaged with the correct sorbent and pro- vides full traceability to the spool number within a product lot. If there is any question, you can bracket down to the spool and quickly isolate the products, which could mean you need look at just 15 cases instead of 1,500. It's just one example of how you can expedite investigations and miti- gate quality upsets. Vendors as partners Vendors who focus on the short term expose you to risks, including the risk of manufacturing substandard products and the inability to resolve problems quickly. That means the cost and disruption associated with quality upsets, infe- rior products, and machine downtime can escalate. To avoid those problems, ask the vendor about: • Commitment to innovation and its track record of sup- porting new drug product formulations; • Ability and willingness to act as a consultative partner to resolve complex challenges; • Ability to customize products to meet your needs; • Experience in the industry; • Reliability of the services and products offered; • Business continuity planning to minimize disruptions and manage your inventory; • Ability to respond to spikes in your demand; • Total cost of ownership versus per-piece pricing; • Processes and systems used to resolve quality events; and • Number of manufacturing sites and whether each site can supply the exact same product. The objective is to reveal the correlation of quality, relia- bility, and cost. Per-piece pricing, for example, can be deceptive because it doesn't factor in the cost of disrup- tions, decreased quality, or inefficiency. The diminished productivity of faulty or underperforming equipment is another hidden cost. By contrast, vendors committed to your long-term success are happy to explain how they will help you overcome challenges. Drug product stability is too important to settle for any- thing but the optimal sorbent and dispensing equipment. That's how you ensure drug product integrity and quality while also meeting your goals regarding quality, reliability, and cost. T&C References 1. Gupta, Pardeep. "Drug product stability and shelf life." Course, Center for Professional Advancement, East Brunswick, NJ. 2. SimulSorb and SimulOx from Multisorb Technologies, Buffalo, NY. 3. DiMasi, JA. "Briefing: Cost of developing a new drug." Tufts Center for the Study of Drug Development, November 18, 2014, Boston. http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_ on_RD_cost_study_-_Nov_18,_2014..pdf. Accessed December 4, 2015. 4. "Generic prescription drug development." Canadian Generic Pharmaceutical Association. July 30, 2015. www.canadi- angenerics.ca/en/resources/docs/DDBookletWebEng.pdf. Accessed December 4, 2015. 5. "PDA survey: Business case for pharmaceutical quality." Parenteral Drug Association, 2012. Chris Gilmor is the commercial director, Americas, for healthcare packaging and Joanne Miechowski is a marketing communications writer for Multisorb Technologies, 325 Harlem Road, Buffalo, NY 14224. Tel. 716 824 8900. Website: www.multisorb.com. Gilmor works with innovator and generic pharmaceutical manufacturers in R&D, quality, regulatory, engineering, and manufacturing depart- ments to identify, select, and dispense the optimal sorbent for stabi- lizing pharmaceutical formulations. He has more than 15 years of experience in the pharmaceutical and chemical industries. It's costly when quality is called into question. Seek dispensing equipment that will minimize upsets and help you identify the source if one occurs. 30 January 2016 Tablets & Capsules