Sr. Doc. Name Issue date Doc. No. Area 01 HVAC Operation Qualification Protocol & Annex (ACU-01) Jan.,2025 OQP-H-00125 Buffer Area 02 HVAC Installation Qualification Protocol & Annex (ACU-01) Jan.,2025 IQP-H-00125 Buffer Area 03 Turn Over Package Report Jan.,2025 TOP-H-00125 Buffer Area…
SPPF-KSA-Steam-Quality
Doc. Name Doc. No. Issue Date Item Name Steam Quality Test Report SQR-V-00325 May, 2025 Steam Generator…
Note that it’s for ( Otsuka Al Obour ) works in Production/Micro Area Sr. Doc. Name Doc No. Issue date Project System 01 LAFs Re-Qualification Protocol (Micro Area) RQP-L-16525 Jun.,2025 RE-QUALIFICATION 02 LAF Re-Qualification Data Sheets (LAF Sterility /B1-L3-19-02) RQP-L-16525/01 Jun.,2025 RE-QUALIFICATION 03 LAF Re-Qualification Data Sheets (LAF Bioburden /B1-L3-15-01) RQP-L-16525/02 Jun.,2025 RE-QUALIFICATION 04 LAF Re-Qualification Data Sheets (LAF Growth promotion /B1-L3-13-01) RQP-L-16525/03 Jun.,2025 RE-QUALIFICATION 05 LAFs Re-Qualification Protocol (Production Area) RQP-L-16625 Jun.,2025 RE-QUALIFICATION 06 LAF Re-Qualification Data Sheets…
SPPF-KSA-THM-WalkIn-Incubator
Doc. Name Doc. No. Issue Date Item Name THERMAL MAPPING PROTOCOL THM-01325 Jun.2025 Walk-In Incubator (LG-07)…
Achievment scope-TAB-Micro lab
Doc. Name Issue date Doc. No. Area 01 Micro lab (AHU-01&02)-Protocol June, 2025 TAB-01625 Micro lab 02 Micro lab (AHU-01)-Annex June, 2025 TAB-01625/1 Micro lab 03 Micro lab AHU-02)-Annex June, 2025 TAB-01625/2 Micro lab…
Achievment scope-Production area
Doc. Name Issue date Doc. No. Area 01 Production area (AHU-01&02)-Protocol June, 2025 TAB-01725 Production area 02 Production area (AHU-01)-Annex June, 2025 TAB-01725/1 Production area 03 Production area (AHU-02)-Annex June, 2025 TAB-01725/2 Production area…
Achievment scope-Micro lab
Doc. Name Issue date Doc. No. Area 01 Micro lab(AHU-01&02)-Protocol June, 2025 RQP-H-06125 Micro lab 02 Micro lab (AHU-01)-Annex June, 2025 RQP-H-06125/1 Micro lab 03 Micro lab (AHU-02)-Annex June, 2025 RQP-H-06125/2 Micro lab…
Achievment scope-Production area
Doc. Name Issue date Doc. No. Area 01 Production Area(AHU-01&02)-Protocol June, 2025 RQP-H-06225 Production Area 02 Production Area(AHU-01)-Annex June, 2025 RQP-H-06225/1 Production Area 03 Production Area(AHU-02)-Annex June, 2025 RQP-H-06225/2 Production Area…
SPPF-KSA-THM-STABILITY
Doc. Name Doc. No. Issue Date Item Name THERMAL MAPPING PROTOCOL THM-01225 Jun.2025 Stability Chamber (AQC-062)…
SPPF-KSA-THM-STABILITY
Doc. Name Doc. No. Issue Date Item Name THERMAL MAPPING PROTOCOL THM-01125 Jun.2025 Stability Chamber (AQC-061)…