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Invoice document for Product quality

when is the best time to start quality by design this question is most asked among many small firms a better way to phrase it is when should I formally document my QbD activities the short answer document the current state of knowledge and risk before the registration campaign begins in reality QbD activities begin before phase 1 this article discusses three reasons why the registration campaign is the perfect time to formally document the quality risk assessments for the drug product and manufacturing process the principles of QbD have become embedded into industry thinking as I discussed in my video quality by design debunking three big myths be sure to subscribe to our Channel and click the notification bell you can find the link to the full article in the description reason 1 capture the current state of knowledge and rely heavily on contract development and manufacturing organizations small firms run lean luckily most CDM O's understand the basics of QbD early development activities are carried out with the critical quality attributes in mind even if they are not formally documented knowledge of the product and process is usually contained in a fixed set of project management deliverables from the CDM o such as campaign reports weekly project updates change controls and deviation investigations it is not uncommon in early phases to have process development runs executed just prior to a production campaign in many instances the parameters are tweaked between batches of the campaign products and processes are not locked and there is a heavy reliance on end product testing to demonstrate fitness for use at this point most viewers are probably thinking tell me something I don't know the registration campaign is a natural point to formally assess the current state of knowledge and plan the next phase of development registration material is typically made for phase three studies or for late phase two studies for products on a fast track either way the registration campaign means the product and the manufacturing process have defined materials and equipment while further optimization and key Beauty studies will be executed in the following months the amount of change from this point forward is greatly reduced the registration campaign is the perfect time to determine what is known versus not known and is not the time for assumptions the QRA reflects the current state of process understanding and serves as a gap analysis between current knowledge and what is still needed it is commonly understood that risk is inversely proportional to process knowledge I use preliminary risk assessments that measure uncertainty as a risk component uncertainty is a measure of the quality and depth of data supporting the risk decision the more uncertainty the greater the risk because of the lower confidence in the final risk decision uncertainty is particularly useful with q Ras and development which work with limited data sets I ask SMEs to reference the data upon which their conclusions are based three main questions really gauge the level of knowledge what do you know how do you know it how good are you the table is a subset of the uncertainty criteria showing a major difference in the level of knowledge category 3 reflects expert opinion and experience while category 2 indicates experimental data supports the conclusion when data supports the conclusion one can go to the study report or other documents where data is captured sometimes the study is well-written executed in these instances the uncertainty is low and the conclusions are fully supported other times data is present and gives a good sense of direction but does not suffice for the final data it can be for a variety of reasons including a statistically poor sampling plan or unvalidated analytical methods on rare occasions the conclusion is based on data assumed to be available but that in fact is not it is not the expectation that everything is final with fully characterized processes or perfect datasets the important point is understanding the known from the unknown the QRA process allows the SMEs to compile and present the knowledge in a logical format which grounds the project team on a common understanding in my experience that has been one of the most value-added activities on a project reason to align with your CDM o engaging the CDM o on the QR a prior to the registration campaign has multiple benefits your CDM o likely has been heavily involved in developing the process and it certainly knows its process flow and equipment formally documenting its knowledge moves it from the realm of tribal knowledge to institutional knowledge it makes the QR a better and ensures the sponsor is on the same page as the CDM o a formal meeting with all functions present is essential many details are overlooked if sponsors do the risk assessment and isolation it is not a good idea to simply have the CDM o review your output risk assessments work best with collaborative interaction as the group chemistry with back and forth discussion teases out information that would otherwise go unnoticed the discussion should be cross-functional it is the time to understand the manufacturing process from different perspectives I particularly like to have these discussions at the CDM OHS manufacturing facility going to the production line to see the equipment and ask questions gives a better appreciation of the process this qra process moves from theoretical to fact-based the main goal is documenting the current state of knowledge and that happens best where the action takes place the factory setting makes the discussions more concrete and specific and lays the foundation for better communication with the CDM o effective communication is the key intangible that ensures success get the best results I find it works best to have a facilitator lead the QR a meeting ideally it would be someone with a technical background it should definitely be someone who understands the risk assessment process having an independent facilitator accomplishes a few things one facilitators allow the SMEs to focus on the details two facilitators help the team ask the right questions three facilitators keep the team from getting bogged down in weeds knowing when to table some of the discussion for facilitators help ensure a consistent output reason three prepare development plan for commercialization by far the best value of the pre-registration campaign qra is ensuring the campaign produces the best quality of information to close specific knowledge gaps the registration campaign provides an opportunity to sample multiple locations and time points don't miss the opportunity to further characterize the process on many occasions the process risk is high because the level of knowledge supporting the decision has high uncertainty here is a preliminary risk assessment for drying after wet granulation for an immediate release tablet in this case the formulation scientist has extensive experience with the excipient and the particular manufacturing equipment the project has progressed quickly with limited data collected expert opinion with some preliminary data is the basis for most knowledge the elevated risk rating reflects the level of uncertainty the QRA identified some key areas of study for the pre-registration engineering batches and the registration campaign itself in particular the team decided to challenge the time and temperature impact on impurities during the engineering batch they would collect data on impurities with the newly validated method they also ensured the test plan included correlating moisture with potency and dissolution the important lesson is the project team determined how to best gather data to fill in holes in the risk assessment they went into the campaign with clear data gathering objectives based on the initial risk evaluation the QRA should be updated after the registration campaign to incorporate the new learning the updated QRA provides the basis for the development activities conducted between the registration campaign and process validation the iterative nature of the QRA allows the project team to adjust experiments to focus resources where they can be most effective conclusion the registration campaign is a huge investment and getting the most from it makes business sense the best practice is to work with the CDM o-- to assess the risk planning data collection beforehand ensures the most valuable data is collected good risk management execution not only ensures the successful registration campaign it lays down the path for development activities culminating and process validation subscribe to our channel and click the notification bell so you don't miss a video