API QUALIFICATIONS IN PHARMA

An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. API Starting Materials normally have defined chemical properties and structure. API Qualifications in pharma is usually carried out by conducting the following activities, individually or combined:

• Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
• Installation Qualification (IQ): documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements.
• Operational Qualification (OQ): documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.
• Performance Qualification (PQ): documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.

1. Performance Qualification Protocol for Double Cone Blender
2. Performance Qualification Report for Double Cone Blender
3. Performance Qualification Protocol for Multimill
4. Performance Qualification Report for Multimill
5. Performance Qualification Protocol for Vacuum Tray Dryer
6. Performance Qualification Report for Vacuum Tray Dryer
7. Performance Qualification Protocol for Stainless Steel Reactor
8. Performance Qualification Report for Stainless Steel Reactor
9. Performance Qualification Protocol for Sparkler Filter
10. Performance Qualification Report for Sparkler Filter
11. Performance Qualification Protocol for Nutsche Filter
12. Performance Qualification Report for Nutsche Filter