GMP Services

  • Quality assurance during pharmaceutical storage is essential for product quality and an integral part of GDP regulations. In order to demonstrate regulatory compliance, storage facilities must be qualified, but this is often a challenging and time consuming task.
Complete and compliant
ELPRO's GMP Services offer a comprehensive service package for a complete qualification of pharmaceutical storage units, including an assessment of the risk involved in the storage process, working through qualification steps from DQ to PQ, and writing the final report.

Customized according to your requirements
Different storage facilities require different qualification approaches based on their current qualification state, the type of storage, or the sensitivity of the product stored. To accommodate these different needs, the ELPRO qualification system is designed in a modular way, allowing you to choose only the qualification modules required. This customized approach allows maximum transparency and cost efficiency.

Here’s how we can help
Using ELPRO’s services helps you overcome internal resource constraints associated with time-consuming qualification projects. Our experienced and qualified experts assist and guide you completely through the qualification process from the initial risk assessment to thermal mappings and the final validation report.

How it works
ELPRO’s qualification services are designed in a modular way, allowing you to choose the activities where you need assistance most, such as:
  • Risk assessment
  • Templates for validation plans and reports
  • Thermal mappings and stress tests
All qualification activities are designed tailor-made according to your requirements, using a state-of-the-art validation approach compliant to GDP regulations.

Your benefits
  • Full storage facility validation service executed by experienced professionals
  • Transparency and cost efficiency through modular qualification approach
Validation
Validating the transportation of a medicinal product can be a challenging task. Benefit ELPRO’s experience in the qualification / validation field and let us assist you in validating your transport processes.

How it works:
ELPRO’s validation services are designed to be modular, allowing you to choose the activities where you need assistance most, such as:
  • Risk assessment
  • Templates for validation plans and reports
  • Thermal mappings and transportation and performance studies
Consulting
A team of experienced specialists is at your service in order to support you in the following GDP / GMP topics:
  • General GMP / GDP compliance analysis
  • MOCK inspections

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