Author: Ramy Zyada

OCTOBER PHARMA-SYRUP AREA

Doc. Name Doc. No. Issue Date Area Air Change Rate Verification Test Report ACH-03024 Dec., 2024 Syrup Area Room Pressure Difference Verification PDT-03324 Dec., 2024 Syrup Area Room Temperature and Relative Humidity Test Report TRH-02524 Dec., 2024 Syrup Area Installed Absolute HEPA Filter Leak Test Report HLT-15324 Dec., 2024 Syrup Area Installed Terminal HEPA Filter Leak Test Report HLT-15424 Dec., 2024 Syrup Area Air Visualization Test Report AVN-05124 Dec., 2024 Syrup Area Air Borne Particle Count Test Report RTT-05024 Dec.,…

OTSUKA AL OBOUR-PRODUCTION & MICRO AREAS

Doc. Name Doc. No. Issue Date Area Poly Ethylene LAF, Sampling LAF & Mobile LAF Operation Re-Qualification Protocol RQP- L -34624 Dec., 2024 Production Area Poly Ethylene LAF Operation Re-Qualification Report RQP- L -34624/01 Dec., 2024 Production Area Sampling LAF Operation Re-Qualification Report RQP- L -34624/02 Dec., 2024 Production Area Mobile LAF Operation Re-Qualification Report RQP- L -34624/03 Dec., 2024 Production Area LAFs Operation Re-Qualification Protocol RQP- L -34724 Dec., 2024 Micro Area LAF Sterility Operation Re-Qualification Report RQP- L…

OTSUKA AL-OBOUR- PRODUCTION AREA

Doc. Name Doc. No. Issue Date Area Compressed Air System Operation Re-Qualification Protocol RQP- G -08724 Dec., 2024 Production Area Compressed Air System Operation Re-Qualification Report RQP- G -08724/01 Dec., 2024 Production Area…

JAMJOOM

Sr. Doc. Name Doc. No Issue date Project System 01 LAF Operation Re-Qualification Report RQP-L-34424 Dec., 2024 QC Area 02 Weighing Booth Operation Re-Qualification Report RQP-L-34524 Dec., 2024 Dispensing Area 03 Lux Measurements Verification Test Report LMR-02024&LMR-02124 Dec., 2024 QC Area & Dispensing Area 04 Compressed Operation Re-Qualification Report RQP-G-08824 Dec., 2024 Non Sterile Area…

Sedico

Doc. Name Doc. No. Area Issue Date HVAC Operation Re-Qualification Report RQP-H-17524 Insulin Area Dec.,2024 LAFs Operation Re-Qualification Report RQP-L-34224 Insulin Area Dec.,2024 Tunnel Operation Re-Qualification Report RQP-L-34324 Insulin Area Dec.,2024 Compressed Operation Re-Qualification Report RQP-G-08624 Insulin Area Dec.,2024…

OTSUKA AL-OBOUR

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Re-Operation Qualification Report RQP-H-17224 Dec.,2024 At Rest 02 HVAC Re-Operation Qualification Report RQP-H-17324 Dec.,2024 In Operation…

Jamjoom Pharma

Micro Area No. Doc. Name Doc. No. Area Issue Date 1 HVAC Operation Re-Qualification Protocol RQP-H-17424 Micro area Dec.,2024 2 LAF Operation Re-Qualification Protocol RQP-L-33524 Sterile Area Dec.,2024 3 Biosafety Cabinets Operation Re-Qualification Protocol RQP-L-33624 Sterile Area Dec.,2024 4 Pass Boxes Operation Re-Qualification Protocol RQP-L-33724 Sterile Area Dec.,2024 5 HVAC Operation Re-Qualification Protocol RQP-G-00225 Solid Area Dec.,2024 6 HVAC Operation Re-Qualification Protocol RQP-G-00325 Dispensing Area Dec.,2024 7 LUX MEASUREMENTS VERIFICATION TEST REPORT LMR-00125 Solid Area Jan., 2025 8 LUX MEASUREMENTS…

GIPPCO

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Re-Operation Qualification Report RQP-H-13924 Dec.,2024 Ground Floor 02 HVAC Re-Operation Qualification Report RQP-H-14024 Dec.,2024 First Floor 03 Compressed Air System Operation Re-Qualification Report RQP-G-08424 Dec.,2024 Production Area…

Kahira Pharmaceutical-Weighing Area

Doc. Name Doc. No. Issue Date Area Weighing Booth Operation Qualification Protocol OQP- L -32524 Dec., 2024 Weighing Area Weighing Booth Operation Qualification Report OQP- L -32524/01 Dec., 2024 Weighing Area…