1. Process Analytical Technologies (PATs), Applications and Benefits Working Group

2. What are PAT? Systems for analysis and control of manufacturing processes based on timely measurements during processing, of critical quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process.

3. Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance) (1) Guidance must allow the development of a PAT whose endpoint is a signature of the quality of the process and process understanding. (2) Implies to be used in an environment of continuous improvement without undue regulatory burden.

4. (3)- All products have critical quality attributes - Process variables exist that can be controlled to maintain these critical quality attributes within acceptable limits. - PATs are applied to achieve both understanding and control of process variables that are causally linked to product critical quality attributes Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance)

5. (4)There are new and developing measurement tools and the guidance should not limit the selection of a tool. (5)Want to encourage companies to move away from current uni-variant prescriptive testing to multi-variant process focused measurements. Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance)

6. (6)PAT can apply to all six* of the manufacturing sub-processes Inbound logistics Active ingredient manufacture Bulk formulation Fill and finish Packaging Outbound logistics * stability testing can be considered a parallel/additional sub-process Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance)

7. (7)The guidance should recognize that new insight into the process, which does not affect the quality of the product for its intended use, should not require mandated changes in process. (8)Allow for the replacement of current or classical methods with PATs for routine testing methods. Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance)

8. (9)The guidance should recognize that PATs will, in large measure, replace current validation requirements (10) The guidance has to define what records has to be kept and for how long. (11) How to involve FDA in PAT development Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in Guidance)