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Quality Compliance looking to provide the best services to our customers, referring to international standards ,since companies, facilities, and laboratories aims to be accredited and certified by a third party as, GMP, GDP, SFDA, WHO, MHRA, FDA and HACCP compliances, and others in addition to its aiming to upgrade and improve its compliance to international standards.
– GMP / Good Manufacturing Practice. – GDP/ Good Distribution Practice.
– SFDA/ Saudi Food and Drug Authority. – WHO/ World Health Organization. – MHRA/ Medicines and Healthcare Products Regulatory Agency – FDA/ Food Drug and Administration. – HACCP/ Hazard Analyses Critical Control Point Quality Compliance will serve these sectors in the fields of Calibration of measuring devices, Qualifications of instruments and Equipment , Temperature mapping for Drug stores , Cold Room, Refrigerator, etc…..and consultation for GMP, GDP requirements in a way of being a partner to Industrial, Medical, and supporting sectors.


Clean room & HVAC Validation

Done as per ISO 14644, SFDA, EU & US FDA State of the art equipment used Performed by highly qualified personnel Can assist/support to validate the following:- Clean room Production area Isolators Laminar air flow hoods and biosafety cabinets Can facilitate to perform the following HEPA filter integrity test Air particle counting Calculation of Air [...]


STERILIZATION VALIDATION Can provide validation/qualification as per 21 CFR 11 complaint system for: Autoclaves Tunnels Ovens Lyophilizes and SIP systems Study includes preparation of protocol, as per the current expectations, and can be modified as per the client internal requirement

Computerized System Validation

Can provide validation services for computerized systems as per: cGMP requirement GAMP5 requirement and 21CFR11 requirement Above service offered for: 1- SAP, 2-ERB 3- EMS/PMS 4- PLC etc.

Calibration/Verification Services

Provided for industrial and medical disciplines to define the accuracy of their results to comply with cGMP and ISO   requirements. 1.Provided at customer site 2.Controlling activities by a computerized calibration manager for scheduling and reporting. Compliant with: -FDA requirement – part 11 – EU-GMP requirement in EUDRALEX 4 – Annex 11 – Perform calibration/verification for [...]
Equipment Validation - Travel-Paulius-Skema

Equipment/Instrument , Building Qualification Study

With certified and traceable instruments for the following: Water treatment systems .Compressed air systems Lab Instrument’s – Water Bath – Dissolution tester – Hardness Tester -Disintegration tester – Friability Tester -HPLC, GC, GC/MS and UV Spectrophotometer

Temperature Mapping / Relative Humidity Mapping

Based on current GDP, GMP guidelines Compliant to SFDA, EU and WHO requirements 21 CFR part 11 compliant software used Can provide mapping services for the following: Warehouses Cold Room Transportation vehicle Fridge’s / Freezer’s/Deep Freezer’s Incubators Stability chambers Ovens Cold chain systems        
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