The Regulatory Gap Analysis enables the identification of specific governmental requirements relative to the cold chain management as they are applied in different countries where business is conducted. Recent trends show some standardization in increased requirements towards tighter control of the cold chain management. Knowing in advance the stakes, the implementation of current regulations requirements will result into better and positive audits, only if adequate preparation takes place to properly address specific requirements.
This risk analysis allows us to highlight critical parameters for the implementation of the cold chain management systems and solutions, as well as upgrade your level of regulatory compliance. The analysis is performed by constantly referring to product profile, product stability, shipment procedures, primary and secondary packaging, documentation management and component specifications, design, qualification (IQ, OQ, PQ), warehouse and storage area monitoring, personnel training, etc.
A complete cold chain analysis is the first step to help you to identify all pertinent parameters that might impact the quality and efficacy of your products. It is the key that will lead you to the step of optimization.
The first step: Cold Chain Quality and Gap Analysis Audit.
The purpose of the cold chain and gap analysis audit, as well as its related documentation, is to verify and establish the pertinence of the cold chain regulations to the audited facility.
Verifications will be made through a close collaboration of the Logistics, Quality Assurance, Quality Control and Shipping/Receiving departments. Following its assessment Alternatives Technologie Pharma will issue a report providing a series of recommendations to improve the existing cold chain compliance level.
Furthermore, ATP might suggest establishing a Master Plan that will specifically enhance the constant management and control of your cold chain compliance.
