Author: Ramy Zyada

Mar.2025 Re-Qualification Project of SPPF-KSA

Sr. Doc. Name Issue date Doc. No. Area 01 Dispensing Booth Re-Qualification Protocol & Annex (Dispensing Booth -1 / AWH-003) Mar., 2025 RQP-L-03125 Dispensing Room-1 02 Dispensing Booth Re-Qualification Protocol & Annex (Dispensing Booth -2 / AWH-004) Mar., 2025 RQP-L-03225 Dispensing Room-2 03 Sampling Booth Re-Qualification Protocol & Annex (Sampling Booth / AQC-080) Mar., 2025 RQP-L-03325 Sampling Room 04 Vial Sterilization Tunnel LAF Re-Qualification Protocol & Annex (Vial Sterilization Tunnel / APD-033) Mar., 2025 RQP-L-03425 Production Department Area 05 LAF…

ARABCOMED

Doc. Name Doc. No. Issue Date Area HVAC Performance Re-Qualification Protocol RQP-H-04125 Mar.,2025 Large volume parenteral wash bay and autoclaves area HVAC Performance Re-Qualification Results Data Sheets RQP-H-04125/01 Mar.,2025 Large volume parenteral wash bay and autoclaves area HVAC Performance Re-Qualification Protocol RQP-H-04225 Mar.,2025 Large volume parenteral tunnel area HVAC Performance Re-Qualification Results Data Sheets RQP-H-04225/01 Mar.,2025 Large volume parenteral tunnel area HVAC Performance Re-Qualification Protocol RQP-H-04325 Mar.,2025 Large volume parenteral preparation and filling area HVAC Performance Re-Qualification Results Data Sheets…

MEPACO-POWDER EXTRACTION

Note that it’s for (MEPACO) works in (POWDER EXTRACTION AREA) Sr. Doc. Name Doc No. Issue date Project System 01  OPERATION QUALIFICATION REPORT OQP-H- 04025 Mar., 2025  AHU 02  TAB REPORT TAB-01325   Mar., 2025  AHU 03 INSTALLATION QUALIFICATION REPORT IQP-H-00425   Mar., 2025  AHU 04 PERFORMANCE QUALIFICATION REPORT PQP-H-00825   Mar., 2025  AHU…

MEPACO-LIQUID EXTRACTION

Note that it’s for (MEPACO) works in (LIQUID EXTRACTION AREA ) Sr. Doc. Name Doc No. Issue date Project System 01  OPERATION QUALIFICATION REPORT OQP-H- 05025 Mar., 2025  AHU 02  TAB REPORT TAB-01225   Mar., 2025  AHU 03 INSTALLATION QUALIFICATION REPORT IQP-H-00325   Mar., 2025  AHU 04 PERFORMANCE QUALIFICATION REPORT PQP-H-00725   Mar., 2025  AHU…

MIDDLE EAST FACTORY-LAB & PRODUCTION AREAS

Doc. Name Doc. No. Issue Date Area Biosafety Cabinet Operation Qualification Protocol                 RQP-H-06925 Mar.,2025 LAB Area Biosafety Cabinet Operation Qualification Results Data Sheets                RQP-H-06925/01    Mar.,2025 LAB Area Pass Box Operation Qualification Protocol                     RQP-H-07025 Mar.,2025 LAB Area Pass Box Operation Qualification Results Data Sheets RQP-H-07025/01 Mar.,2025 LAB Area Pass Box Operation Qualification Protocol   RQP-H-071025 Mar.,2025 Production Area Pass Box Operation Qualification Results Data Sheets RQP-H-07125/01 Mar.,2025 Production Area…

HP PHARMA-Compressed Air System

Sr. Doc. Name Doc No. Issue date Project System 01 Compressed Air System Installation Qualification Report IQP-G-00125 Mar., 2025 Production Area 02 Compressed Air System Operation Qualification Report OQP-G-01625 Mar., 2025 Production Area 03 Compressed Air System Performance Qualification Report PQP-G-00125 Mar., 2025 Production Area…

MARKRYL PHARMA-MICROBIOLOGY AREA

Doc. Name Doc. No. Issue Date Area HVAC Performance Re-Qualification Protocol                       RQP-H-03925 Mar.,2025 Microbiology Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-03925/01 Mar.,2025 Microbiology Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-03925/02 Mar.,2025 Microbiology Area Safety Cabinets Performance Re-Qualification Protocol        RQP-L-07225 Mar.,2025 Microbiology Area Safety Cabinet Performance Re-Qualification Results Data Sheets RQP-L-07225/01 Mar.,2025 Microbiology Area Safety Cabinet Performance Re-Qualification Results Data Sheets RQP-L-07225/02 Mar.,2025 Microbiology Area Isolator Performance Re-Qualification Protocol    RQP-L-07325 Mar.,2025 Microbiology Area Isolator…

NERHADOU-MICRO AREA

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Re-Qualification Report RQP-H-03825 Mar., 2025 AHU-05 02 Pass Boxes Installation Qualification Report IQP-L-00225 Mar., 2025 Phase II…