Author: Ramy Zyada

Sedico-units

Sr. Doc. Name Doc No. Issue date Project System 01 Safety Cabinet Operation Re-Qualification Protocol & Annex RQP-L-16023 Sep.,2023 Microbiology 02 INSTALLED HEPA FILTER LEAK TEST REPORT From : HLT-12623 To      : HLT-13723 Sep.,2023 Oncology Plant 03 AIR VELOCITY VERIFICATION TEST REPORT From : FHV-000423 To      : FHV-000623 Sep.,2023 Microbiology 04 AIR VISUALIZATION TEST REPORT (NUDAF) From : FHP-000423 To      : FHP-000623 Sep.,2023 Microbiology…

(DAR ) Works in Dar New Premises Building (Air Side & Chilled Water System)

Sr. Doc. Name Doc No. Issue date Project System 1.   HVAC Testing , Adjusting & Balancing Report (Air Side) TAB-09023 Oct.,2023 Dar New Premises Building 2.   HVAC Testing , Adjusting & Balancing Report (Chilled Water System ) TAB-09123 Oct.,2023 Dar New Premises Building 3.   Turn Over Package TOP-00923 Oct.,2023 Dar New Premises Building 4. Sequence Of Procedures – mar.,2024 Dar New Premises Building…

(MARCYRL) Works in (Units)

Sr. Doc. Name Doc No. Issue date Project System 1 Operation Re-Qualification Protocol & Annex RQP-L-13923 Aug., 2023 Units 1- Pass Box-5(Disinfectant) / S27_PB 2- Pass Box-6(Autoclave) / S29_PB 3- Pass Box-7(DE-Gowning) / S24_PB 4- Mobile LAF 1 / PR_33 5- Mobile LAF 2 / PR_34 6- Filling Machine LAF / PR_23 7- Compounding LAF / PR_31 8- Disinfectant LAF / PR_29 9- Garments washing LAF / PR_32 10- Tools Washing LAF / PR_30 2.   Operation Re-Qualification Protocol &…

(third party) Works in (kitchen Area)

Sr. Doc. Name Doc No. Issue date Project System 1 AIR FLOW RATE TEST REPORT ACH-05723 Sep., 2023 Kitchen Area 2 FAN PERFORMANCE & AIR FLOW RATE TEST REPORT FPT-01223 Sep., 2023 Kitchen Area 3 WATER FLOW RATE MEASUREMENTS REPORT WBR-01123 Sep., 2023 Kitchen Area…

(HVAC Operation Qualification ) In (SIGMA)

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Operation Qualification Protocol & Annex OQP-H-09723 Sep.,2023 SOLID 02 HVAC Operation Qualification Protocol & Annex OQP-H-09823 Sep.,2023 MICRO 03 HVAC Operation Qualification Protocol & Annex OQP-H-09923 Sep.,2023 DISPENSING 04 HVAC Operation Qualification Protocol & Annex OQP-H-10023 Sep.,2023 BLISTERING 05 HVAC Testing, Adjusting & Balancing Protocol & Annex TAB-09423 Sep.,2023 SOLID 06 HVAC Testing, Adjusting & Balancing Protocol & Annex TAB-09523 Sep.,2023 MICRO 07 HVAC Testing, Adjusting & Balancing Protocol…

(Gentech) Works in (Solid , Sampling, Dispensing& Micro Areas & LAFs )

Sr. Doc. Name Doc No. Issue date Project System 1   Operation Re-Qualification Protocol & Annexes for Solid Area RQP-H-10423 Sep., 2023 Solid Area   2 Operation Re-Qualification Protocol & Annexes for Sampling & Dispensing Area RQP-H-10323 Sep., 2023 Sampling & Dispensing Area   3 Operation Re-Qualification Protocol & Annexes for Sampling & Micro Area RQP-H-10723   Sep., 2023 Micro Area 4   Operation Re-Qualification Protocol & Annexes for LAFs& Pass boxes in Dispensing Area RQP-L-15023 Sep., 2023 Dispensing Area…

(JEDCO) Works in (Solid Area & Semi Solid Area)

Sr. Doc. Name Doc No. Issue date Project System 1.   Operation Re-Qualification Protocol & Annexes for Solid Area RQP-H-10523 Sep., 2023 Solid Area 2.   Operation Re-Qualification Protocol & Annexes for Semi Solid Area RQP-H-10623 Sep., 2023 Semi Solid 3.   Compressed Air System Operation Qualification Protocol & Annex RQP-G-03023 Sep., 2023 Compressed Air System in Production Area 4.   LAF Operation Re-Qualification Protocol & Annex RQP-L-15523 Sep., 2023 LAF P-OC-01 5.   LAF Operation Re-Qualification Protocol & Annex…

(HVAC Operation Re-Qualification ) In (EGYPHAR Old Factory)

Sr. Doc. Name Doc No. Issue date Project System 01 HVAC Operation Re-Qualification Protocol & Annex RQP-H-08923 Sep.,2023 Dispensing 02 HVAC Operation Re-Qualification Protocol & Annex RQP-H-09023 Sep.,2023 Liquid 03 HVAC Operation Re-Qualification Protocol & Annex RQP-H-09123 Sep.,2023 Sampling 04 HVAC Operation Re-Qualification Protocol & Annex RQP-H-09223 Sep.,2023 Solid 1 05 HVAC Operation Re-Qualification Protocol & Annex RQP-H-09323 Sep.,2023 Solid 2…

SPPF-Qualification AHUs, LAFs & Pass boxes-KSA

Sr. Doc. Name Doc. No Issue date Project System 1.0 SPPF Requalification Protocol (AHU-08, 09 & 16) OQP-H-01023 Sep., 2023 RE-Q Protocol 1.1 SPPF Requalification-Annex (AHU-08) OQP-H-01023/01 Sep., 2023 RE-Q Annex 1.2 SPPF Requalification-Annex (AHU-09) OQP-H-01023/02 Sep., 2023 RE-Q Annex 1.3 SPPF Requalification-Annex (AHU-10) OQP-H-01023/03 Sep., 2023 RE-Q Annex Sr. Doc. Name Doc. No Issue date Project System 1.0 Pass Box Protocol & Annex (APD-046) RQP-L-00723 RQP-L-00723/01 Sep., 2023 RE-Q Protocol & Annex 1.1 Pass Box Protocol & Annex (APD-045)…