Issue link: https://www.e-digitaleditions.com/i/947832
Tablets & Capsules March 2018 15 equipment and level of automation to suit your needs. If not, determine the costs, in time and money, to modify the company's equipment or purchase new equipment to meet your process requirements and successfully manu- facture your product. Be sure to ask whether these expenses are included in the proposal cost. The CMO must prepare a proposal and present it to you. You need to assess the proposal as part of the bid tab or contract evaluation. If the CMO does purchase new equipment, determine the equipment's delivery lead time and when the equipment will be qualified. Ask for the findings of the most recent process simulation and whether the process experienced any problems. Can the CMO's equipment accurately dose your material? Ensure that the CMO's equipment has adequate dose-accuracy control to meet your specifications. You have a legal and regulatory responsibility to meet all label claims, so you must verify that the drug product contains the dose stated on the label. Final product units with too much or too little API can potentially harm patients. Also, consistently adding more than the specified amount of API to the final product unit unnecessarily increases production costs. How does the CMO's equipment handle rejects? Ask whether the equipment is built to reduce rejects and what the rejection rate is for a given batch size to ensure that the rate is satisfactory. You'll also want to know what controls are in place to prevent excursions and whether the bulk of a batch can be preserved if a machine failure occurs. Is the CMO's equipment obsolete? Manufacturing technology advances rapidly, especially in the area of microelectronic sensors, vision systems, and analytical instrumentation. The advancement occurs so fast, in fact, that equipment more than five years old is likely to be obsolete and may not have adequate sensors or instrumentation to detect critical defects in-line, which can lead to wasted product and lost revenue. When touring a facility, ask how old the equipment is and ask to see it run. Inquire about the equipment manufacturer and any problems the CMO has had with the equipment. For example, you may find that, while the equipment has been in storage for just four years, the machines are actually 20 years old. Be sure to ask about the availability of spare parts and how the CMO will replace parts if needed. For example, are the machines controllers even available for purchase new or will the CMO have to shop at online bidding sites to try to find replacement parts? Is the CMO's staff experienced with your product and the required technology? Suspension and high-viscosity products require different knowledge and experience compared to solution products. Highly potent and cytotoxic products require different skills and expertise to maintain a safe environment for equipment operators. Additionally, your process may require the use of specialized technology including vision systems, laser sensors, flow meters, gravimetric systems, decontamination