| Are you looking to develop a capacity plan model for | | | | to be validated. Process validation is "establishing, |
| a pharmaceutical testing lab? Here are some things to | | | | through documented evidence, a high degree of |
| consider using a pharmaceutical QA/QC laboratory | | | | assurance that a specific process will consistently |
| supporting a manufacturing facility as an example. | | | | produce a product that meets its predetermined |
| First, consider your minimum testing load based on | | | | specifications and quality characteristics." Any new |
| manufacturing forecasts. Each batch of drug product | | | | processes will have to be validated and established |
| will require a minimum number of tests before, during, | | | | processes are normally revalidated periodically as |
| and after manufacturing including: | | | | specified in the facility's "Master Validation Plan." |
| - Testing of raw materials used in the process | | | | Process validations often require enormous amounts |
| - Testing to ensure process equipment is clean | | | | of analytical resources to handle the validation sample |
| - In-process testing to ensure process is performing | | | | load, and these resources compete with routine |
| within specifications | | | | testing, so you will want to plan for validations in |
| - Final product testing for release to market | | | | your model. |
| - Product stability testing (as required for some | | | | Finally, you should consider the introduction of new or |
| batches) | | | | changed processes and new products to the plant. |
| For each one of those areas you would need to | | | | These are also huge consumers of analytical |
| model the number of samples required, the time it | | | | resources as they include activities such as analytical |
| takes to analyze the samples, and the time it takes | | | | method development, method transfer, and method |
| to get the results approved. The time it takes to get | | | | validation in addition to the support and testing of |
| the results approved can be rate-limiting, so don't | | | | "scale-up," demonstration, and validation batches. |
| ignore it. | | | | These batches also will have long-term and |
| Now, if every process performed perfectly every | | | | accelerated stability samples associated with them. |
| time, that's basically all you would need. But they | | | | Also, since they are new processes, they will |
| won't run perfectly; there will be problems ranging | | | | generally have more investigations associated with |
| from simple analyst errors to unexplainable | | | | them. |
| out-of-specification (OOS) results. | | | | Remember, a pharmaceutical process produces two |
| Errors and OOS results require formal documented | | | | products: the drug product and the paperwork |
| investigations that can be quite time-consuming. | | | | documenting the manufacturing and testing. A |
| Some products are more problematic than others | | | | manufactured batch of drug product without the |
| and have more associated investigations. So you | | | | proper paperwork is worthless because it cannot be |
| want to understand the history of each product and | | | | released to the market. I want to emphasize that |
| plan for the resources and time required for | | | | the preparation and approval of the documentation |
| investigations in your model. | | | | can be very time-consuming, so it is critical that you |
| Next, pharmaceutical manufacturing processes need | | | | map these processes and include them in your model. |