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SERVICES

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.


TULUM

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 [...]
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STERILIZATION VALIDATION

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
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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.
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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
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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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