Signature Service Toll Manufacturing Agreement Made Easy

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learn three key questions to help you choose the right contract development and manufacturing organization choosing the right CD MO is the most important factor leading to the success of drug product development small and virtual pharmaceutical companies outsource their product and process development as well as their manufacturing it is the CDM OS that executes the projects they have the biggest impact on your overall success to be successful you must look past the opening presentation the facility walkthroughs and even the compliance audit I am a firm believer in the team approach to vendor selection you need the right people asking the right questions if you are to make a wise decision the vendor needs to be well rounded and well staffed and your selection team should be the same here are three things to consider when selecting a CDM o if you haven't done so be sure to subscribe to our Channel and click the notification bell one does it have adequate human capital no project proceeds right the first time on budget and on time unless the people executing the project have sufficient expertise in sufficient quantity great facilities with compliant QMS are very important but they are not the prime factors that ensure success it is the people at the CDM o who have the biggest impact on project success you cannot simply audit your way into selecting the best CDM oh you must assess both the skills of the people and their capacity to take on new projects when it comes to skills great CDM OHS will anticipate your needs for example one European CDM o had a deviation on analytical transfer due to a new impurity being identified by the time we came to work in America they had already proposed a tentative impurity structure and examined other Lots to see if the impurity was present our ability to act quickly and to assess the magnitude of the problem was facilitated by the CDM o knowing what to do and acting accordingly the quality management system and facilities did not drive those results the competence and decision-making ability of the people running the facility and QMS did having competent people is not enough there should be enough competent people to execute your project ahead CDM owes that pass the quality audit and had people who interviewed well in person however the bandwidth of the key individuals was stretched resulting in delays on critical path items investigations took longer than needed reports were not right first time the best of people would create substandard work when stretched too thin in one case the CDM o had only one analytical method expert who could troubleshoot problems and draw scientific conclusions he had too many projects demanding his time our project suffered and it was not because of the scientist he simply had too many tasks and make it a point to assess the following on my audits do the validation records and investigations demonstrate competent scientific thought are they timely do they have a backlog in investigations how many senior scientists and engineers do they have in relation to the project load will your project be the proverbial straw - do they understand quality risk management quality by design has become expected in regulatory submissions identifying critical quality attributes and critical variability is the heart of the control strategy and writing the chemistry and manufacturing controls section every CDM o sales presentation has slides on the company's approach to Quality by Design you need to remove the bows and ribbons and take a deeper look is there substance behind the best words you can assess their risk management understanding by examining their equipment qualifications do they follow the is PE approach to direct impact and indirect impact systems risk management principles should be woven into their records from installation qualification through performance qualification they should have a well documented risk-based approach to cleaning validation did they identify and challenge difficult to clean locations and process materials the facility monitoring program should follow a risk-based approach as well the sampling locations and intervals should be data based and take process risk into account the important factor is gauging the CDM OHS understanding and application of risk management principles these system records do not have customer proprietary information and therefore should be available for your review I want to see tangible examples of how they identify critical process variability they should provide examples of experiments they typically run how have they identified critical parameters and projects like yours what challenges did they overcome when reviewing investigations look for a risk-based approach to analyzing the data do they correlate the data to the critical quality attributes even if they are not formally defined do they execute purposeful experiments is there a documented rationale for the plan does the rationale make scientific and risk-based sense or does it seem like trial and error if this seems like a job interview then good you got my point it is one of the most important job interviews you can conduct three can they meet your analytical development needs by far analytical development is the number one reason projects fall behind schedule the amount of time and resources needed to properly execute an adequate analytical program is often grossly underestimated I want to make sure the important message is clear the overall project success will rise or fall based on the validity of the analytical methods the analytical methods generate the data the development scientists use to plan experiments the generate data to characterize the product they produce the data used in investigations they generate the data used to release the product they support the regulatory submission it surprises me how many times the difficulty of analytical development is underestimated the common question in all projects is how much analytical validation is needed at a given phase of development I like to answer with how much project risk are you willing to take and how are you going to prove the methods are fit for phase problems arise when teams try to cut corners to shave time off the development schedule firms struggle with when to spend money on a project that can lead to delays and beginning analytical activities when schedules get crunched analytical development can become one of the casualties hence the competence of the CDM o to effectively develop and validate methods is critical will the project take on extra risk because the CDM o does not have enough capacity the CDM o must have an F available capacity to meet the rigors of the project timeline your CDM o is the one developing and executing these methods can they execute the things needed when needed look beyond the obvious such as linearity accuracy robustness and specificity do they have the bandwidth and expertise to generate chemical markers for validation are they managing their marker production or are you when can they qualify reference standards do they have a process do they have the capacity to properly store all the reference standards are they competent to deliver the reference standards to your other labs that need them do they have a pattern of qualifying standards at the last minute before they either run out of time or reach the retest date if you can only check one thing understand how the CDM o executes and a little we'll transfer either as the sending laboratory or receiving laboratory if they treat the analytical transfer as a check the box exercise move on my favorite nightmare was when the sending and receiving labs did not use the same qualified reference standard the two labs did not have equivalent detectors the validation did not account for differences than detection methods the receiving lab did not integrate the baseline the same way as the sending lab I could go on and on but you get the point the CDM o must be able to address the details of the analytical transfer conclusion choosing a CDM o is the most important task on your development timeline it is a decision that has a lasting impact on your success I believe in spending money where it matters most giving the biggest upside and mitigating the biggest downside choosing the right CDM o is the place to spend the money so choose wisely subscribe to our channel what would you like to see leave a suggestion in the comments on the topics you want