Author: Ramy Zyada

EGYPHAR-TAG

Sr. Doc. Name Doc No. Issue date Project System 1 HVAC Operation Re-Qualification Reports for Soft Gelatin Area RQP-H-11224 July, 2024 Soft Gelatin Area…

EGYPHAR – Dispensing, Liquid & Sampling

Sr. Doc. Name Doc No. Issue date Project System 1 LAFs Operation Re-Qualification Reports for Dispensing Area RQP-L-23124 May., 2024 Dispensing Area 2 LAFs Operation Re-Qualification Reports for Liquid Area RQP-L-23224 May., 2024 Liquid Area 3 LAFs Operation Re-Qualification Reports for Sampling Area RQP-L-23324 May., 2024 Sampling Area…

Apex- KSA- LAFs & Pass box Test Reports

Doc. Name Doc. No. Issue Date Area Filter Air Velocity Verification Test Report (Laminar air flow/QCE-020) FVT-00324 Aug.,2024 Micro Area HEPA Filter Leak Test Report (Laminar air flow/QCE-020) HLT-03024 Aug., 2024 Micro Area Air Visualization Test Report (UDAF) (Laminar air flow/QCE-020) AVU-00324 Aug., 2024 Micro Area Air Borne Particle Count Test Report (Laminar air flow/QCE-020) PCR-00424 Aug., 2024 Micro Area Filter Air Velocity Verification Test Report (Laminar air flow/QCE-021) FVT-00424 Aug., 2024 Micro Area HEPA Filter Leak Test Report (Laminar…

MEDMAC-Production Area

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Installation Qualification Report IQP-H-03124 Jul.,2024 Production Area 02 HVAC Testing, Adjusting & Balancing Report TAB-07024 Jul.,2024 Production Area 03 HVAC Operation Qualification Report OQP-H-10724 Aug.,2024 Production Area 04 LAFs Operation Qualification Report OQP-L-19924 Aug.,2024 Production Area 05 Pass Boxes Operation Qualification Report OQP-L-20024 Aug.,2024 Production Area…

JamJoom – Non-Sterile

Sr. Doc. Name Doc No. Issue date Project System 1 HVAC Lux Meassurment Verification Test Reports for Semi-Solid Area LMR-00424 June, 2024 Semi-Solid Area 2 HVAC Lux Meassurment Verification Test Reports for Solid Area LMR-00524 June, 2024 Solid Area 3 HVAC Lux Meassurment Verification Test Reports for Dispensing Area LMR-00624 June, 2024 Dispensing Area 4 HVAC Lux Meassurment Verification Test Reports for Micro Area LMR-00724 June, 2024 Micro Area 5 HVAC Lux Meassurment Verification Test Reports for Sampling Area LMR-00824…

(GYPTO)_ (Solid Extension area)  

Sr. Doc. Name Doc No. Issue date Project System 1 HVAC Installation Qualification Reports IQP-H-02924 Aug., 2024 Solid Extension Area 2 Testing, Adjusting & Balancing Reports TAB-06624 Aug., 2024 Solid Extension Area 3 HVAC Operation Qualification Reports OQP-H-10224 Aug., 2024 Solid Extension Area…

JamJoom – Micro & QC Area

Sr. Doc. Name Doc No. Issue date Project System 1 LAFs Operation Re-Qualification for Micro Area OQP-L-21524 June, 2024 Micro Area 2 Biosafety Cabinet Operation Re-Qualification for Micro Area OQP-L-21624 June, 2024 Micro Area 3 Pass Box Operation Re-Qualification Report for Micro Area OQP-L-21724 June, 2024 Micro Area 4 LAFs Operation Re-Qualification for QC Area OQP-L-21824 June, 2024 QC Area 5 Pass Box Operation Re-Qualification Report for QC Area OQP-L-21924 June, 2024 QC Area…

Sedico Strile Pencillin Area – RQ

Doc. Name Doc. No. AHU Name Area Issue Date HVAC Operation Re-Qualification Protocol ROQP-H-10124 AHU1 & AHU2 & AHU3 Sterile Penicillin Area Jul,2024 HVAC Operation Re-Qualification Report ROQP-H-10124/1 AHU1 & AHU2 & AHU3 Sterile Penicillin Area Jul,2024…

(Servier)_ (Micro area)

Sr. Doc. Name Doc No. Issue date Project System 1 Operation Re-Qualification Report ( Safety Cabinet / QC-083) RQP-L-19624 Aug., 2024 Micro Lab Area…