Issue link: https://www.e-digitaleditions.com/i/316458
48 May 2014 Tablets & Capsules I run a contract packaging com- pany, and I get all kinds of questions from new customers. Most questions are specific to the job, but two are fairly common. "What is your normal lead time?" Is that a trick question? Allow me to pose it a little differently: "From the time I get you all my materials and signed approvals, how long will it take to package my product?" If your project is very large or entails a lengthy campaign, ask for the expected run rate of the product. You may also want to know the spe- cific type of equipment to be used. For example, if your product will be packaged in a blister, ask how many blisters the machine forms per cycle. At what cycle speed has that format been qualified? With this informa- tion, it's fairly simple to calculate how many hours, days, or weeks your job might take. I also recom- mend you compare this information with the data you gathered during your capabilities audit. There are a few other aspects to keep in mind, too. Approvals. Waiting for you, the customer, to approve printed material proofs is a common source of delays. In fact, proof approvals often take- longer, in calendar days, than actual production. They are also a major cause of missed target dates. Product on site. It's a good idea to discuss production windows and how they relate to our receipt of your bulk tablets or capsules, especially if they're to be delivered by a third party. Most contract packagers prefer to schedule a production slot only after the bulk product is in house and all approvals are documented. Rule #1 in contract packaging: If we don't have it, we can't pack it. Tooling. If your blister packaging job requires custom tooling, ask about the issue as soon as possible, because that could extend the lead time and cause delays due to ap - provals. We also need to price the tooling. To get the best pricing on a job, match the number of blisters per cycle (format size) to the run size and line speed. Larger runs are more likely to call for larger tooling for- mats to overcome speed constraints. "Can you take care of my track-and- trace responsibilities?" My response to this question is a question: What responsibilities are you asking about? I'm not sure that I under- stand yet what the different responsi- bilities are or whose they are. In fact, I don't think the FDA really knows. Here is what I am prepared to do: • Place a machine-readable, matrix code on each individually dis- pensable package of drug product. The code will represent a secure, randomly generated, unique iden- tification number that will follow that unit to its final destination. An automated system will record the new package and its new iden - tification number. • Place that uniquely identified pack- age into a shipper carton of the size and design you prefer, along with the number of sibling packages that you assign to the shipper. The sys- tem will "take attendance" in the shipper by reading the unique identification numbers and assign- ing them to their new container. The shipper will be closed and labeled with both human- and machine-readable documentation that will allow it to be tracked to a pallet that meets your shipping specification. • Give each pallet of product its own equally informative label that will relate to a data package as - sembled for your entire batch. • Assemble an electronic data pack- age for your batch that contains the previously assigned identity of the product you shipped to me and that records its chain of cus- tody from my dock to your truck. That data package will be compat- ible with industry systems and will present the identification of each individual package, the shipper, its siblings, and the pallet identifica- tion. I will provide that data pack- age to you in whatever industry- compatible format you select. I know what you're thinking: "That was the easy part!" And you're right. But the rest of track and trace is up to you. T&C [Editor's note: To comment on the Back Page, visit www.tabletscap sules.com.] Steven J. Mead is presi- d e n t o f F u t u r e P a k , 2 8 1 1 5 L a k e v i e w D r. , Wixom, MI 48393. Tel. 248 486 0045, fax 248 4 8 6 0 8 8 6 . We b s i t e : www.futurepak.com. b a c k p a g e Glad you asked: Lead times, track and trace n-BP_48_q-Backpage_72 5/14/14 10:20 AM Page 48