Sr. Doc. Name Doc. No Issue date Project System 01 HVAC Design Qualification Report (Protocol & Annexes) DQP-H-01121 Aug., 2021 Syrup, Solid, Dispensing, Sampling, Micro & Sterile 02 HVAC Installation Qualification Report (Protocol & Annexes) IQP-H-01021 Aug., 2021 Syrup, Solid, Dispensing, Sampling, Micro & Sterile 03 Testing, Adjusting & Balancing Report (Protocol & Annexes) From TAB-23621 To TAB-24021 Aug., 2021 Syrup, Solid, Dispensing, Sampling, Micro & Sterile 04 HVAC Operation Qualification Report (Protocol & Annexes) From OQP-H-05921 To OQP-H-06321 Aug.,…
SGS (P&G)-Test Reports
Sr. Doc. Name Doc. No Issue date Project System 01 AIR CHANGE RATE (Test Report) From ACH-02321 To ACH-02621 Sep,2021 Controlled & Protected Areas 02 ROOM PRESSURE DIFFERENCE (Test Report) PDT-01321 Sep,2021 Controlled & Protected Areas 03 ROOM TEMPERATURE AND RELATIVE HUMIDITY (Test Report) TRH-01121 Sep,2021 Controlled & Protected Areas 04 AIR BORNE PARTICLE COUNT (Test Report) PCR-06821 Sep,2021 Controlled & Protected Areas…
SGS (P&G)-Compressed Air System Operation Qualification
Sr. Doc. Name Doc. No Issue date Project System 01 Compressed Air System Operation Qualification Report (Protocol & Annex) OQP-G-00621 Sep,2021 Production Area…
Rameda-LAF Qualification
Sr. Doc. Name Doc. No Issue date Project System 01 Test Report – Air visualization Test Report AVU-04721 Sep, 2021 Pass Box Qualification 02 Test Report – Pressure Difference Across Hepa Filter PDH-05521 Sep, 2021 Pass Box Qualification 03 Test Report –Filter Air velocity FVT-06321 Sep, 2021 Pass Box Qualification 04 Test Report – Installed Hepa Filter Leak Test HLT-20521 Sep, 2021 Pass Box Qualification 05 Test Report –Air Born Particle Count PCR-06721 Sep, 2021 Pass Box Qualification 06 Test…
SAJA Pharma- Re-Qualification
Sr. Doc. Name Doc. No Issue date Project System 01 Operation Re-Qualification (Protocol & Annex) RQP-H-05621 April,2021 Production Area 02 Operation Re-Qualification (Protocol & Annex) RQP-H-05721 April,2021 Micro Area 03 Operation Re-Qualification (Protocol & Annex) RQP-H-05821 April,2021 Sampling & Dispensing Area…
Gemech (APEX PHARMA)-Air Shower Operation Qualification.
Sr. Doc. Name Doc. No Issue date Project System 01 Air Shower Operation qualification (Protocol & Annex) OQP-L-05521 Sep. 2021 APEX Pharma Solid Area Air Shower (MASG001) Operation Qualification…
JEDCO (Re-qualification)
Sr. Doc. Name Doc. No Issue date Project System 01 JEDCO Re-qualification (Protocol & Annex) RQP-H-05321 April, 2021 JEDCO Sampling Area Re-qualification (AHU-F-04)…
Servier-Re-Qualification (SERVIER I & SERVIER II)
Sr. Doc. Name Doc. No Issue date Project System 01 Operation Qualification (Protocol & Annex) RQP-H-05421 Sep.,2021 OQ (SERVIER I) 02 Operation Qualification (Protocol & Annex) RQP-H-05521 Sep.,2021 OQ (SERVIER II)…
HIKMA-HEPA Filter Leak Test
Sr. Doc. Name Doc. No Issue date Project System 01 Installed HEPA Filter Leak test (Test Reports) From HLT-19421 to HLT-20221 Sep., 2021 HEPA Filter Leak test…
JEDCO-Re-Qualification (Hard Gelatin & Micro Area)
Sr. Doc. Name Doc. No Issue date Project System 01 Operation Qualification (Protocol & Annex) RQP-H-05121 April,2021 OQ (Hard Gelatin) 02 Operation Qualification (Protocol & Annex) RQP-H-05221 April,2021 OQ (Micro Area)…