Simplify Your Storage Compliance
Peace of mind that your regulatory storage requirements are met
Service at a Glance
Warehouse Mapping Service delivers the required evidence to demonstrate that environmentally sensitive products have been stored in accordance with Good Manufacturing and Distribution Practices (GMPs and GDPs).
Our turnkey service includes:
- Advice and creation of performance qualification protocols (PQ)
- Temperature and humidity profiling, to evaluate storage conditions and identify critical zones
- Analysis of worst case environmental conditions, for example, winter versus summer time
- Carrying out validation procedures
- Quality reviews and report creation
- Documenting of modifications
- Repeat testing at required intervals
Can You Afford to Risk Non-Compliance?
Regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA) increasingly require temperature and humidity profiles of storage and distribution warehouses to demonstrate that environmentally sensitive products have been maintained within a GMP or GDP compliant environment.
It is important to consider the risks that can affect product quality before making the necessary mitigation and validation plans. If procedures are not well understood, audit failures can occur which not only result in waste product but also have a negative impact on a company’s reputation.
Carrying out successful warehouse mapping involves a process of steps which can require trained individuals with expert knowledge in certain areas, such as GMPs, GDPs, Data Acquisition and Analytics, Storage Methods and HVAC (Heating, Ventilation and Air Conditioning).
Peace of Mind That Regulatory Requirements Are Met
PACE field services team have a wealth of knowledge and expertise in environmental monitoring and temperature uniformity surveys and calibration services in Karachi Pakistan. Supplied as a service or as part of a Customer FIRST Service Level Agreement program, our knowledgeable team can carry out the comprehensive set of tasks needed to help you prove that your environmentally sensitive products have been stored within their specified limits, to satisfy regulatory requirements.
Engineering and Equipment Provided
We will provide and locate the high stability temperature and humidity sensors and calibrated equipment for data logging, and define and carry out the mapping and validation procedure. Sensors will be placed in a defined pattern and monitored at stated intervals for a specified length of time to take into account different periods of operations in the warehouse, and the specifications for the type of products being stored. Acceptable limits for temperature and humidity excursions will also be stated and reported.
- Supply and placement of high stability temperature and humidity sensors
- Setup of calibrated equipment for data logging
- Monitoring at different periods of operation in the warehouse to define worst case areas
- Carrying out of the mapping and validation procedure
Performance Qualification Documentation
PACE Engineering work with you to create your validation plan in order to define the equipment, plant and personnel protocol needed to maintain a GMP/GDP environment. As experts in measurement and environmental monitoring they will be able to offer advice on the validation process as well as provide the equipment required.
Our background in Environmental Monitoring Systems provides the expertise needed to define areas where product quality may be at risk from temperature and humidity deviations, such as where HVAC systems or fans may cause variations or where temperature gradients can occur due to storage warehouse layout or HVAC system design.
- Expertise in the measuring and monitoring of temperature and humidity
- Knowledgeable ISPE GAMP Guideline trained engineers
- Advice on storage methods, defining environmentally critical areas, layout of sensors, and validation procedures
Comprehensive Hassle Free Reports
Our comprehensive report will provide easily readable graphical and tabular results of your warehouse data with time and dates as well as other requested calculated values such as min, max and average. Information such as instrument settings, calibration certification and pass/fail information are also included for review and approval by your responsible quality personnel.
Where unacceptable extremes of temperature or humidity are identified, we will help and advise on changes to be made to storage or HVAC systems as well as documenting the modifications and updating the validation procedure and calibration services in Karachi Pakistan
- Thorough reporting that provides the information required by quality personnel to help meet GMP/GDP audits
- Advice on changes to be made to storage or HVAC systems
- Documentation of recommendations, modifications and updating of the validation procedure
Environmental Monitoring System Solutions
For warehouses that require continuous monitoring to conform to GMPs, Eurotherm also offer fully engineered and validated Environmental Monitoring Systems (EMS).
A Continuous Life-Cycle Service
Subsequent mapping activities can be scheduled within a Eurotherm Service Level Agreement to occur on an agreed frequency.