Secure your cold chain
The pharmaceutical industry remains legally responsible for its product until the drug is actually administered. Regulatory compliance with drug temperature guidelines at all stages of the cold chain is now systematically verified by regulatory agencies (FDA, EMA, ANSM ...).
An appropriate organization must be put in place to efficiently and quickly mark all temperature breaks in the foid chain. Axys-Network and its consultants assist biotechnology companies and drug manufacturers in order to remain compliant (WHO - PIB - GMP - ICH) and solve their cold chain problems
Our methodology to guarantee your cold chain
Situation: cold chain management is the sum of the interactions of several critical processes tightly regulated by all health authorities. Many products, Drug Substances (DS), Drug Product (DP) or medical devices (DM) as well as certain cosmetic products are products sensitive to high temperature. Today, a global vision becomes difficult because of the number of partners and actors with different backgrounds and understandings.
Objectives: The product must be protected throughout the life cycle during the various stages concerned, with dedicated specifications, from the start of the chain to the use of the drug at the patient level. We must take into account the complexity of the whole process in order to guarantee aligned practices for the entire supply chain. Cold chain compliance and industrial performance are not mutually exclusive. Our proposal based on years of experience in the largest pharmaceutical companies incorporates this problem. This is divided into four stages:
- Verification and evaluation of the cold chain (in relation to the requirements of GMP, GDP, WHO and the client)
- Methodology: Risk assessment followed by a Gap analysis
- Definition of root causes in case of problems. How to avoid bad decisions to release lots at the production site.
- Remediation and recommendations to guarantee compliance while maintaining performance:
- Stability studies based on scientific argumentation to allow control of the appropriate process (mainly temperature and "out of excursions")
- Time out of Refrigeration (TOR) to give confidence to the advanced stages carried out by producers (DS, DP and intermediaries)
- Packaging and package specifications to ensure reliability between objectives and transport and handling practices
- Transport: monitoring and recording the temperature conditions required by the product and the logistics chain.
- Identification of risks and gaps
- Remediation and recommendations
- Compliance and readiness inspection
- Safety and customer satisfaction