Issue link: https://www.e-digitaleditions.com/i/947832
16 March 2018 Tablets & Capsules systems, or analytical equipment such as an optical density meter to monitor homogeneity. Make sure the CMO's staff has training and experience with all the technologies your manufacturing process requires. Production capacity A CMO that already has clients may have a small window in which to produce your drug product. To determine a CMO's ability to fit you into its production schedule, ask the following questions: Does the CMO have the capacity to meet your production demands? If the batch size and length of time required to produce your drug product on the CMO's machines increases your risk of not having the product when you need it, the CMO isn't a good fit. You can do a quick calculation by dividing the batch size by the machines' capacity (units per minute or hour) to determine the approximate amount of time needed to manufacture your drug product. Note that this calculation doesn't account for total production time, as a calculation of overall equipment effectiveness (OEE) would. Will you be a small fish in a large pond? If the batch size and number of lots for your product are small, a large CMO might delay production of your product in order to satisfy a larger customer. If you're manufacturing for a specific period or for seasonal distribution and miss the production date, you could lose your market share. If you do choose a large CMO, you may need to dedicate resources at the CMO's site to advocate on your behalf or at least ensure that the CMO will notify you if a production delay occurs. Contamination prevention Because a CMO's equipment may be running one client's product one day and another client's product the next, preventing cross-contamination is critical. Make sure the CMO's cleaning procedures between products are sufficient. Determine whether the facility produces any highly hazardous compounds and, if so, how they're controlled and contained. While each facility should have its own containment strategy, you may still want the CMO to use a separate set of equipment-format and product-contact parts exclusively for your product runs. Also, drug products created for specific high-risk populations may have additional containment requirements. Make sure the CMO can accommodate your needs. Training CFR Part 211 and various FDA Guidances require that pharmaceutical companies train staff members and document that training. Evaluate the CMO's training records as part of your initial quality compliance audit. Also, observe and assess the company's training practices as part of your technical evaluation during the due-diligence period. The CMOs training should include general current good manufacturing practices (cGMP) training, identification and understanding of CQAs, proven acceptable ranges, critical process parameters, critical operational parameters, and other product specifications. Training should also include any knowledge related to your product, your standard operating procedures (SOPs), and your analytical methods. This will ensure that staff members understand why your procedures are written the way they are and that they can manufacture your product and determine whether it's acceptable for use. Regulatory observations Because pharmaceutical manufacturing facilities are built to protect the equipment operators, the drug products, and patients, quality systems and facility and equipment design are critical. Research the CMO's history with regulatory agencies, its documentation practices, and its process and testing procedures, including the company's responsiveness to problems and any previously documented corrective and preventive actions (CAPAs). Search on the FDA's website for the CMO's previous inspection observation summaries [1]. When was the CMO's last inspection, and what were the findings? What were the CMO's responses to remediate the observations? Were the responses accepted and the corrective actions completed and verified? Personal interviews Finally, don't rely solely on a CMO's industry reputation and experience; conduct personal interviews with the company's executives, management, and current staff on site before signing a contract. Interview previous and existing customers and rely on vendors' feedback. Ask what drug products the company has produced and if the staff has experience with drug products like yours. Ask the staff for examples of developmental or troubleshooting work they've successfully executed to determine whether they'll be able to handle any such needs for your drug product. Also, ask if the CMO has had any recalls, and, if so, what the root cause was and whether they've corrected the problem. T&C References 1 . A v a i l a b l e a t h t t p s : / / w w w . f d a . g o v / I C E C I / Inspections/ucm250720.htm. Christa Myers is senior pharmaceutical engineering specialist, and Kevin Debbs, CPIP, is process specialist at CRB USA, headquartered in Kansas City, MO (www. crbusa.com/christa-myers).