Tag: Annex 15

Spray Dryer (Respirable Particles) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Spray Dryer in Inhaled NDDS Purpose: To establish a standardized approach for the validation of the Spray Dryer used in the production of engineered inhalation particles, ensuring compliance with regulatory requirements and quality…

Jet Mill / Spiral Mill – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Jet Mill / Spiral Mill Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference]…

Jet Mill / Spiral Mill – 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] [URS_Statement_1] [Risk_Level_1] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2] [URS_Statement_2] [Risk_Level_2] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2] [URS_ID_3] [URS_Statement_3]…

Jet Mill / Spiral Mill – Validation Summary Report (VSR) Template

Validation Summary Report Equipment: Jet Mill / Spiral Mill Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: R&D/Production DQ/IQ/OQ/PQ Flags Design Qualification: Yes Installation Qualification: Yes Operational Qualification: Yes Performance Qualification: Yes Acceptance Criteria Reference URS Annex 11 Annex…

Jet Mill / Spiral Mill – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: Jet Mill / Spiral Mill Area: R&D/Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description of Deviation: Classification Deviation Classification: Minor Major Critical Product/Patient Impact Product/Patient Impact Assessment: Data Integrity…

Jet Mill / Spiral Mill – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Jet Mill / Spiral Mill Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: R&D/Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration certificates reviewed…

Jet Mill / Spiral Mill – PQ Protocol

Document Control Number: PQ-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Performance Qualification Protocol for Jet Mill in Inhaled NDDS Powders Equipment Validation NDDS Jet Mill Spiral Mill Pharmaceutical Objective The objective of this Performance Qualification (PQ) protocol is…

Jet Mill / Spiral Mill – OQ Protocol

Document Control Document ID: OQ-JM-SM-001 Version: 1.0 Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Operational Qualification Protocol for Jet Mill and Spiral Mill in R&D/Production Meta Description: This document outlines the Operational Qualification (OQ) protocol for…

Jet Mill / Spiral Mill – IQ Protocol

Document Number: IQ-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Name] Approval Date: [Date] Installation Qualification Protocol for Jet Mill/Spiral Mill Used in Micronizing API for Inhalation Objective: To ensure that the Jet Mill/Spiral Mill is installed correctly and operates…

Jet Mill / Spiral Mill – DQ Protocol

Document Control: Document ID: DQ-001 Version: 1.0 Effective Date: YYYY-MM-DD Review Date: YYYY-MM-DD Prepared by: [Your Name] Approved by: [Approver’s Name] Design Qualification Protocol for Jet Mill / Spiral Mill in Inhaled NDDS Powder Production Meta Description: This document outlines…