01 Nov Cold Chain Validation
Obligations no longer stop at the warehouse door. Cold chain qualification is now actively audited and enforced by regulatory bodies. Ensuring quality of product and patient safety highlights the emphasis for good cold chain management practices. Implementation of good cold chain practices is essential to ensure that proper handling, storage and distribution of environmentally labile pharmaceutical products are adhered to by all pharma companies.
As a third of all cold chain shipments are now accounted for by pharmaceutical and biotechnology sectors, GN Engineer Services Ireland provides a service that can validate all areas of this industry segment whilst satisfying regulatory requirements.
This qualification process is a step-by-step temperature and humidity monitoring study to insure that at each stage of product storage and transportation the product remains within acceptable environmental conditions.
GN Engineer Services provide services in the following areas:
- Risk management approach to cold chain
- Raising awareness with all staff involved in the cold chain
- Testing of packaging systems to ensure compliance
- Explanation of procedures involved
- Development of SOPs for correct transport of products
- Temperature and humidity mapping of all transport methods
- Conducting worse-case comparison studies
- Analysis of results and comparison to previous stability studies
- Validation Master Plan
- Preparation of Protocols
- Risk Assessment