The Standard for Pharma Solution
Objective of URS for Bio Safety Cabinet TABLE OF CONTENT Description Page No. Title page Table of contents Approval of Documents Objective Scope Location of equipment Communication Applicable codes and standard System/equipment/instruments details Scope of supply Brief system description Technical specification Safety features … Read more
Objective of URS for Autoclave Autoclave is a critical equipment used in pharmaceutical and microbiology laboratories for sterilization of materials. Proper sterilization is essential to ensure product quality, safety, and compliance with GMP requirements. This document describes the URS for Autoclave a 300 Liter Fully Automatic Autoclave intended for laboratory and pharmaceutical applications. Table of … Read more
Objective of URS for Sonicator: This document is generating under the authority of the company for the purpose of specifying the user requirement for Sonicator. The URS for Sonicator is provided to define the important components, variables and options necessary for the Supplier to provide a functional of sonicator that meets the needs in the … Read more
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