Our goal is to get you approved in audits-hence we sit down with you and understand the kind of processes you have to ensure QMS is in-place and in-use.
The consultancy would be doing a gap analysis and Identifying deficiencies in the entire process against QMS Standards and also conduct internal audit.
Once the consultancy understands the entire system and the gap analysis and internal audit have been completed we provide you with an action plan with dates
After all the work has been identified and actions have been executed, we rerun our gap analysis to ensure we are where we targeted. We ensure that your QMS Audit is completed successfully.
AIJAZ NASSER -AN QMS CONSULTANCY is headed by AIJAZ ALI NASSER who holds a Master’s degree in Microbiology and Bsc.Honours with Biochemistry have worked for 32 years in GlaxoSmithkline in various Quality Assurance and Quality Control positions and retired in 2018 from the position of Supplier Quality Auditor ASIA PACIFIC MIDDLE EAST AFRICA.
He is currently a principal auditor registered with IRCA(IRCA registration no.01200525) ,was nominated in 2018 as finalist of international quality award in UK by chartered quality institute, have deep knowledge of Quality Management system was GlaxoSmithkline Internal QualityAuditor and Compliance manager and then worked for almost 10 years as supplier quality auditor in the region and HAS DONE OVER 300 EXTERNAL SUPPLIER AUDIT AND SOME REMOTE ASSESSMENT OF SUPPLIERS OF API,STERILE API, EXCIPIENTS, FLAVOURS,PRIMARY PACKAGING,PRINTED PACKAGING AND STERILIZATION SERVICES AND AGENTS ,its records are now present in IRCA database and AUDIT LOGS are available, which gradually led him to the position of Principal Auditor IRCA/CQI and also contributed to his nomination as finalist of international quality award in UK by chartered quality institute in 2018.As GSK employee AIJAZ also did audit of Packaging Material supplier in Leicestershire UK(Multipackaging) and API supplier in Oman.(Oman Chemicals and Pharmaceuticals)
For years AIJAZ worked as QMS training manager delivering lectures and sessions on Quality Management system covering almost 100 Global Quality Policies and Global Quality Management processes on topics of pharmaceutical Quality Management ,Personnel, Facilities Equipment, Raw material Management, Documentation, Laboratory Control. Qualification and Validation. Rejection and Reworks and Returns and Change control.
The various position held during his carrier include Manager Microbiology QC, Manager Validation and Compliance, Manager Technical Services QA, Manager Operational Excellence. Audit Training and Documentation Manager, QMS Training Manager, Operational Quality Manager and Supplier Quality Auditor for South Asia, Supplier Quality Auditor for Europe Middle East and Supplier Quality Auditor for Asia Pacific middle East Africa.
AIJAZ RETIRED AND LEFT GSK IN END 2018 TO SET UP HIS OWN CONSULTANCY IN 2019,WHICH IS REGISTERED WITH PAKISTAN FEDERAL BOARD OF REVENUE AND BANKING IN PAKISTAN
The Supporting Team of the consultancy:
1. QMS OFFICER
ALI ASGHAR NASSER, the QMS officer, arranges and schedules the consultancy work with the customers
2. QMS DOCUMENTATION
KANIZ FATIMA the Documentation In-charge, maintains the Documentation and Records pertaining to consultancy work.
QMS CONSULTANCY WORK UNDERTAKEN BY AN QMS CONSULTANCY which included:
Compliance check of the design of the plant according to ISO9000:2015,WHO Standards and ICH Q7 and GSK pharmaceutical standard requirement for API, Excipients, primary packaging, printed packaging service providers and sterilization units. Providing of all SOP’s for QMS implementation, Training on A processes and SOPs, Qualification of process equipment with Engineering, Production, and QA team ,Conducting Internal Audit with the team
1. NOVATEX PVT.LTD. Karachi Pakistan, a primary packaging plastic bottle manufacturer was provided QMS Consultancy for 4 months in all the Quality Functions. ,
2. OLEOCORP PVT.LTD. Karachi PAKISTAN is a manufacturer of Glycerin obtained from Plant Origin.The Glycerin plant started manufacturing in the second Quarter of 2019,EXCIPIENT SUPPLIER
3. CITI Pharmaceuticals Pv.t Ltd. Lahore Pakistan. A manufacturer of Active Pharmaceutical Ingredients API Paracetamol ,Penicillin and others was provided QMS Consultancy for months in all the Quality Functions.
4. BALOCHISTAN GLASS LTD. HUB city Pakistan a primary packaging glass bottle manufacturer, was provided QMS Consultancy for 2 months in all the Quality Functions.
5. Allied Axiom Pvt. Ltd A manufacturer of LIQUID AND DRY FLAVORS used in manufacturing was provided QMS Consultancy for 3 months in all the Quality Functions.
6. Collapsible Tube Company a supplier of collapsible Aluminum tubes to pharmaceutical and consumer companies was provided QMS Consultancy for 3 months in all the Quality Functions in 2020 and 2024.
7. Pakistan Electron Beam Irradiation Services ,that provides sterilization services for pharmaceutical products, its complete QMS function development and most importantly its validation according to ISO 11137 was also overseen by the Auditor
8. Pharma Packages Faisalabad, a manufacturer of Aluminum Flip Off Seals, Tear Off Seals used on vials of injectables, was provided QMS Consultancy for 2 months in all the Quality Functions.
9. B.B. Minerals, Korangi Karachi ,a manufacturer of Magnesium Tri-silicate used in manufacturing of tablets was provided QMS Consultancy for 3 months in all the Quality Functions.
10. Citi Pharmaceutical Ltd, API Manufacturer was provided training on DATA INTEGRITY AUDITS.
11. Ehtesham Packages Ltd Karachi, a manufacturer of Printed Cartons was provided QMS Consultancy for 2 months in all the Quality Functions.
12 Guides Corporation, does import stores of different excipients and chemical was provided QMS Consultancy for 2 months in all the Quality Functions.
13. KRYSTALLITE PRODUCTS PVT.LTD. Karachi supplier of PET BOTTLES, HDPE CAPS AND CHILD RESISTANT HDPE CAPS QMS Consultancy for 3 months in all the Quality Functions.
14. Zain Packaging Industries – Karachi – Printed cartons and labels. was provided QMS Consultancy for 2 months in all the Quality Functions.
15 MATCO Food Pvt. Ltd. CSD plant Faisalabad was provided complete quality function consultancy for Pharmaceutical excipient, for a period of 8 months including designing of their new filling and packaging area for pharmaceutical grade Corn Starch
IN 2020 AN QMS CONSULTANCY SIGNED A CONTRACT WITH GLAXOSMITHKLINE OVERSEAS PRIVATE LTD TO CONDUCT AUDIT OF THEIR SUPPLIERS, ACCORDING TO GSK GLOBAL AUDIT STANDARD WHICH IS COMPLIANT TO ISO9001:2015.
THE LEVEL 3 OF THE GSK GLOBAL AUDIT STANDARD WHICH IS USED FOR EXCIPIENTS HAS SIMILAR REQUIREMENTS TO THAT OF EXCIPACT WHEN COMPARED.
WHO STANDARD AND ICH Q7 GUIDELINES WERE THE OTHER 2 STANDARDS USED DURING THE AUDITS OF APIs.
1. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier MERIT PACKAGING PVT LTD.secondary Printed Packaging Supplier.
2.Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier TECHNO GLASS PVT. LTD. GLASS AMPOULES Primary Printed Packaging Supplier.
3..Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ALPHA CHEMICALS PVT. LTD.AN ACTIVE PHARMACEUTICAL MATERIAL(API TRIMETHOPRIM PLANT) SUPPLIER.
4. .Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier PAKISTAN OXYGEN PVT. LTD.EXCIPIENT SUPPLIER FOR STERILE PRODUCTS, SURFACE OXYGEN or CARBON DIOXIDE.
4..Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ZENITH PACKAGING PVT .LTD.PRIMARY Printed Packaging Supplier. ( ALUMINUM FOIL/PVDC FILMS)
5..Supplier Quality Audit). by AN QMS CONSULTANCY of GSK supplier REHMPACK PVT. LTD. Printed Packaging Supplier.(primary & Secondary
6. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ACT POLYOLS (PVT) LIMITED manufacturer of 70% sorbitol solution.
7. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Alpha Chemical Lahore ( Pseudoephedrine & Sulphamethoxazole plant)
8. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ALUCAN Pakistan Ltd supplier of collapsible aluminum tubes.
9. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Aluminum Processing Ind. Pvt. Ltd. Karachi supplier of printed aluminum foil.
10. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ALUPAK PAKSTANKarachi supplier of collapsible aluminum tubes.
11. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier AUVITRONICS LTD. Karachi.supplier of PET Bottles, HDPE and LDPE Bottles, Plastic Closures
12. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier KRYSTALLITE PRODUCTS PVT.LTD. Karachi supplier of PET BOTTLES, HDPE CAPS AND CHILD RESISTANT HDPE CAPS.
13. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier — Bahria Environmental Research Center (Laboratory) contract laboratory for outsourced testing
14. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Burhani STS Industries (Pvt.) Limited –Karachi sof printed laminated tubes.
15. Supplier Quality FOLLOW-UP complete Audit by AN QMS CONSULTANCY of GSK supplier Burhani STS Industries (Pvt) Limited –Karachi sof printed laminated tubes
16. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Citi Pharma (Pvt) Ltd.-Lahore API Paracetamol plant
17. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Citi Pharma (Pvt) Ltd.-Lahore Cephradine plant.
18. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Zenith Chemical Industries.-Lahore– API Paracetamol plant.
19. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Citi Pharma (Pvt.) Ltd.-Lahore( API Paracetamol DC granules plant).
20. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Citi Pharma (Pvt.) Ltd.-Lahore CIPROFLOXACIN plant.
21. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Citi Pharma (Pvt.) Ltd.-Lahore Penicillin plant.
22. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Friends glass pvt.ltd.– KP province – Printed glass Ampoules.
23. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Ghani Glass Limited –Karachi-Glass bottles
24. Supplier Quality Remote assessment by AN QMS CONSULTANCY of GSK agent Guides Corporation, imports and storage of 18 different excipients and chemical used by GSK.
25. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier HABIB Sugar Mills Ltd–Nawabshah. – Granulated Sugar and Alcohol.
26. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Health Capsules Pakistan (Pvt.) Ltd.–Faisalabad- Empty Hard gelatin Capsules.
27. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Kamran Enterprises -Karachi– Silica Gel bags.
28. Supplier Remote Assessment by AN QMS CONSULTANCY of GSK Klarg Exports – Karachi–importer of excipient titanium dioxide
29. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier M.P. Enterprises ––Lahore- Carbon dioxide gas
30. GSK supplier Remote assessment of MARTIN DOW SPECIALITIES PVT.LTD. by AN QMS CONSULTANCY– Importer of 15 different excipient for pharmaceutical preparations.
31. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Mirpurkhas Sugar Mills Ltd –Mirpurkhas city —Granulated sugar.
32. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier National Metal Packaging -Karachi – Roll-on pilfer proof caps
33. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier NATIONAL CARE PACK –Karachi – PRINTED BOTTLES, CAPS AND NOZZLES.
34. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Rafhan Maize Products – Faisalabad- Corn Maize
35. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Oleo Corp Pvt. Ltd. Karachi – Glycerin
36. Remote assessment report of The Orientals – Karachi by ANQMS consultancy – Calibration Service provider.
37. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pak Gum and Chemicals – Karachi- Guar Gum.
38. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pak Electron Beam – Karachi- Electron Beam Sterilization
39. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier PAKISTAN OXYGEN LTD – Karachi- Liquid Nitrogen, Nitrogen and Oxygen gases.
40. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pakistan Packages –Karachi- Printed Cartons and Labels.
41. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pakistan Radiation Services – Lahore – Sterilization Services.
42. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier PERVEZ LAUNDRY – Karachi – Laundry Services for Production uniform.
43. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pharma Packages – Faisalabad – Aluminum Flip Off Seals.
44: Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pharmagen Ltd. – Lahore – STERILE INJECTABLE CEPHADRINE L-ARGININE
45. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pharmagen Ltd. – Lahore AMOXICILLIN,AMPICILLIN, CLOXACILLIN,CEPHALEXIN ,CEPHADRINE and CEFIXIME.
46. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Pharmagen Ltd. – Lahore – API PARACETAMOL.
47. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier POLYMER PLASTIC MOULDING – Karachi – PLASTIC(HDPE) BOTTLES, SPOONS,CAPS, DROPPERS, JARS,INJECTION TRAYS AND POLYSTYRENE JARS.
48. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier
49. PRECISION SOLUTIONS PVT. LTD – Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Karachi – PRINTED PLASTIC BOTTLES. PLASTIC CLOSURES AND NOZZLES.
50. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Prince Art Packages UNIT -2 – Karachi – Printed Labels ,Cartons and Leaflets.
51. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Production House Pvt. Ltd –Karachi – HEAT ALUMINIUM SEALS/ INDUCTION SEALS.
52. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Royal Printing and packages – Karachi – Plastic Droppers, Collapsible PlasticTwin spoon , Cylindrical Spoons and Flexidose
53. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier SICPA Inks -Pakistan-Karachi – SELF ADHESIVE LABELS AND TAMPER EVIDENT SEALS.
54. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Super Fine Art Business – Karachi – LEAFLETS.
55. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Swano Dry Cleaners –Karachi- PENICILLIN UNIFORMS AND RELATED LINEN.
56. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier SYNERGY PACKAGING PVT.LTD.-Karachi – PET BOTTLES Pharma Grade
57. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Techno Ampoules Pvt.Ltd. 2020 –Karachi – Printed Glass Ampoules.
58. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Techno Ampoules Pvt.Ltd. 2022 –Karachi – Printed Glass Ampoules.
59. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier TOP N PLASTIC –Karachi-Plastic spoons for Oral Products.
60. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Zain Packaging Industries – Karachi – Printed cartons and labels.
61. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Zenith Chemical Industries Pvt Ltd-Pakistan—Lahore – API Paracetamol.
62. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier Follow-up audit Zenith Chemical Ind. Pvt. Ltd.—Lahore – API Paracetamol.
63. Supplier Quality Audit by AN QMS CONSULTANCY of GSK supplier ZENITH Packaging Ltd. –LAHORE- Primary Printed Packaging.
Please feel free to leave a message or call me at +92-0301 8247916
or email us at aijaz.nasser@gmail.com
Postal Address :
7/4 Rimpa Skyline 209 E.I. Lines
Shah Rah Faisal Opposite Hotel Mehran
Postal code 74400,
Karachi Pakistan.