The Standard for Pharma Solution
URS for FBD (Fluidized Bed Dryer) Objective of URS for FBD (Fluidized Bed Dryer): This document was generated under the authority of the company for the purpose of specifying the user requirement for URS for FBD (Fluidized Bed Dryer). The User Requirements Specification (URS) is provided to define the important components, variables and options necessary … Read more
OBJECTIVE of PQ For Tray Dryer To determine that the PQ For Tray Dryer perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal condition, and where appropriate the worst case situations. TABLE OF CONTENT … Read more
OBJECTIVE of PQ for Blender To determine that the PQ for Blender perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal condition, and where appropriate the worst case situations. TABLE OF CONTENT PARTICULARS PAGE … Read more
OBJECTIVE of PQ for Metal Detector To determine that the PQ for Metal Detector perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal condition, and where appropriate the worst case situations TABLE OF … Read more
OBJECTIVE of PQ for RLAF (Reverse Laminar Air Flow) To determine that the PQ for RLAF (Reverse Laminar Air Flow) perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that it consistently meets pre-determined specifications under normal condition, and where appropriate the … Read more
Objective for PQ of Hardness Tester To carry out the PQ of Hardness Tester as per approved, OQ in company.. The scope of this document is to confirm that the design, implementation and operation of the Hardness Tester, meet its design intention, specifications and operational requirements. This document details the dynamic attributes of the instrument, … Read more
Objective of PQ for Disintegration Test Apparatus (DT) To carry out the performance qualification of the PQ for Disintegration Test Apparatus (DT) as per approved protocols The scope of this document is to confirm that the design, implementation and operation of the DT apparatus, meet its design intention, specifications and operational requirements. This document details … Read more
OBJECTIVE for PQ of Bio Dot Dispenser To determine that the PQ of Bio Dot Dispenser perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that perform consistently meets per-determined specifications under normal condition, and where appropriate the worst case situations. TABLE … Read more
Objective for OQ of RLAF (Reverse Laminar Air Flow) To determine that the OQ of RLAF (Reverse Laminar Air Flow) perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that installation consistently meets per-determined specifications under normal condition, and where appropriate the … Read more
Objective for PQ for Dynamic Pass Box To determine that the PQ for Dynamic Pass Box perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that it consistently meets pre-determined specifications under normal condition, and where appropriate the worst-case situations. To verify … Read more