• Info@compliance.com.sa.
  • +966 55 5045841

SERVICES

According to SFDA requirement for pharmaceutical stores, temperature mapping for storage area, cold room and vehicle must be done at least once in winter and once in Summer. In addition, this was not only required by SFDA but most of international Authorities mentioned that in their regulation e.g. EU, MHRA, USFDA and WHO.
The benefit of Temperature Mapping is to document the temperature variation and qualifies temperature. This can include but is not limited

  • Warehouses.
  • Cold Room.
  • Transportation vehicle
  • Fridge’ss / Freezer’s/Deep Freezer’s
  • Incubators.
  • Stability chambers
  • Ovens
  • Cold chain shippers, packing qualification and testing
  • Thermal Mapping of Steam staralizer (Autoclve) dy Heat Oven, (Heat distribution Studies, and Heat Penetration Studies) by using thermal validator.

The temperature mapping exercise is expected to collect the following information:

  • The impact of interventions (door openings / power failures, etc.)
  • dentification of hot and cold spot
  • Variation of temperature at a single point
  • Temperature variation across the area
  • Length of time of any temperature excursions.
  • The impact of interventions (door openings / power failures, etc.)
  • The impact of interventions (door openings / power failures, etc.)
  • The impact of interventions (door openings / power failures, etc.)

Temperature mapping and equipment qualification are mandatory for other industries For example:

healthcare

where blood bags and medicines are stored and incubators, freezers and refrigerators (WHO Guideline for blood establishment)

Food

Storage areas, cold rooms, freezers and vehicles ( ATP Agreement)


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 [...]
image

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
gp-referral

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.
Calibrations-Small

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
images

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        
Compliance © 2015 All right reserved