Category: Uncategorized

MARCYRL-STERILE AREA

Doc. Name Doc. No. Issue Date Area HVAC Performance Re-Qualification Protocol                       RQP-H-04725 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-04725/01 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-04725/02 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-04725/03 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-04725/04 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Protocol                     RQP-H-04825 Mar.,2025 Sterile Area HVAC Performance Re-Qualification Results Data Sheets                   RQP-H-04825/01 Mar.,2025 Sterile Area…

KLYBECK-KSA-PRODUCTION & MICRO AREAS

Doc. Name Doc. No. Issue Date Area Pass Box Operation Qualification Protocol OQP-L-04925 Feb.,2025 Production Area Pass Box Operation Qualification Report OQP-L-04925/01 Mar.,2025 Production Area Pass Box Operation Qualification Protocol         OQP-L-05025 Feb.,2025 Micro Area Pass Box Operation Qualification Report OQP-L-05025/01 Mar.,2025 Micro Area…

KLYBECK-KSA-THM-Protocols & Reports-Jan. & Feb. 2025 Scope

Sr. Doc. Name Doc. No. Issue Date Item Name 01 PERFORMANCE QUALIFICATION PROTOCOL PQP-HT-00725 Jan., 2025 SIP Freeze Dryer (VPR/E/104) 02 PERFORMANCE QUALIFICATION REPORT PQR-HT-00725 Jan., 2025 03 PERFORMANCE QUALIFICATION PROTOCOL PQP-T-00525 Jan., 2025 Cold Room (VPR/E/234) 04 PERFORMANCE QUALIFICATION REPORT PQR-T-01125 Jan., 2025 05 PERFORMANCE QUALIFICATION PROTOCOL PQP-T-00425 Jan., 2025 Ice Boxes at Cold Room 06 PERFORMANCE QUALIFICATION REPORT PQR-T-01025 Jan., 2025 07 PERFORMANCE QUALIFICATION PROTOCOL PQP-HT-00625 Jan., 2025 Steam Sterilizer Autoclave (VPR/E/003) 08 PERFORMANCE QUALIFICATION REPORT PQR-HT-00625 Feb.,…

COPAD PHARMA / POWDER FILLING ROOM1 /PRO-25

Sr. Doc. Name Doc No. Issue date Project System 01 AIR CHANGE RATE TEST REPORT ACH-00825 Mar.,2025 Production Area 02 ROOM PRESSURE DIFFERENCE TEST REPORT PDT-00525 Mar.,2025 03 ROOM TEMPERATURE AND RELATIVE HUMIDITY TEST REPORT TRH-01625 Mar.,2025 04. AIR BORNE PARTICLE COUNT TEST REPORT PCR-01025 Mar.,2025 05. RECOVERY TIME TEST REPORT RTT-01725 Mar.,2025  …

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…