Issue link: https://www.e-digitaleditions.com/i/845331
Tablets & Capsules July 2017 19 Yet the development paradigm is not always well doc- umented. Listed below are some typical comments made by the FDA in the review of several recent New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) regarding the manufacture of immediate- and extended-release solid dosage forms: • How are the manufacturing steps (unit operations) related to drug product quality? • How were the critical quality parameters identified, monitored, and/or controlled? • No details are provided for identifying, monitoring, and controlling the critical process parameters (CPPs) in the drug product. It is not clear how both the manufac- turing process and CPPs were identified as no actual experimental data are provided. • Many of the process parameters in each unit opera- tion are listed as "criticality undetermined" or "not criti- cal"; please provide your risk assessment for all process parameters for each unit operation. Please provide the control strategy for this product based on product devel- opment information. • Please provide an updated flow chart and manufac- turing description indicating each unit operation, in- process control points, and in-process tests to be con- ducted at each control point. • The table identifying the critical quality attributes (CQAs) from the quality target product profile (QTPP) identified drug product attributes as "not critical" because they do not affect safety and efficacy. However, these CQAs may have an impact on drug product quality attributes, such as assay. Please re-evaluate and provide an updated control strategy. If you're a formulator developing a drug product, it is paramount that you know and understand how the prod- uct will be manufactured in a production setting. This is a key element of the formulation and process development paradigm and an essential building block of a high-quality product. High quality requires good planning It is a simplistic analogy, but think of formulation devel- opment in terms of developing the recipe for a cake. The result should mimic a packaged cake mix, which includes or lists all the ingredients required and provides complete yet simple instructions. By using these ingredients and fol- lowing the directions, you create a cake that has the appearance, texture, and taste described in the product's literature. The cake mix represents a well-defined formula- tion, manufacturing process, and control strategy that enables a home baker to produce a delicious dessert. Whether it is a cake, tablet, or capsule, the formula- tion development process is the same: Identify the ingre- dients and their essential properties and quantities. Likewise with process development: Specify the equip- ment, CPPs, and times. The result is a formulation and manufacturing process with a defined control strategy,