Tag: Annex 15

Inline Sifter (Transfer Line) – PQ Protocol

Document Control Document Number: PQ-OSD-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed by: [Name] Approval Date: [Date] Performance Qualification Protocol for Inline Sifter in Solid Dosage Form Objective: The objective of this Performance Qualification (PQ) protocol is to verify that the…

Inline Sifter (Transfer Line) – OQ Protocol

Operational Qualification Protocol for Inline Sifter in Solid Dosage Form Document Number: OQ-IS-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Operational Qualification (OQ) protocol is to verify that the Inline Sifter operates…

Inline Sifter (Transfer Line) – IQ Protocol

Document Control: Protocol Number: IQ-OSD-IS-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Reviewed By: [Insert Name] Approved By: [Insert Name] Installation Qualification Protocol for Inline Sifter in Solid Dosage Form Production Objective: To verify that the Inline…

Inline Sifter (Transfer Line) – DQ Protocol

Design Qualification Protocol for Inline Sifter Equipment in Solid Dosage Form Production Document Control Number: DQ-OSD-001 Version: 1.0 Date of Issue: 2023-10-01 Reviewed by: [Name] Approved by: [Name] Objective The objective of this Design Qualification (DQ) Protocol is to establish…

Inline Sifter (Transfer Line) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Inline Sifter Equipment Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a framework for the validation of Inline Sifter equipment utilized in the production of solid dosage forms, ensuring…

Rotary Sifter – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Rotary Sifter Subcategory: Solid Dosage Form (OSD) Area: Production/Sieving Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Requalification Frequency: 24 Months Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution…

Rotary Sifter – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result [URS ID 1] The Rotary Sifter must achieve specified sifting efficiency for powders. [H/M/L] [DQ Test Ref 1] [IQ Test…

Rotary Sifter – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report provides a comprehensive overview of the validation activities conducted for the Rotary Sifter used in the Solid Dosage Form (OSD) production area. The report outlines the Design Qualification (DQ), Installation Qualification…

Rotary Sifter – Deviation Impact Assessment

Deviation Impact Assessment Equipment Information Equipment: Rotary Sifter Area: Production/Sieving Criticality: Major Product Impact: Direct Deviation Details Deviation Description: [Insert deviation description here] Date of Deviation: [Insert date here] Reported By: [Insert name here] Classification Deviation Classification: Major Product/Patient Impact…

Rotary Sifter – Qualification Execution Checklist

Qualification Execution Checklist for Rotary Sifter Equipment: Rotary Sifter Subcategory: Solid Dosage Form (OSD) Area: Production/Sieving DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified Preventive Maintenance (PM) status verified Protocol…