Aside of medicinal products and active pharmaceutical ingredients, the storage of pharmaceutical excipients is tied to special requirements, too. Ensuring excipient quality during storage – especially of sensitive pharmaceutical excipients – is the highest good. In order to accomplish this it is not only mandatory to keep with the defined storage conditions. It is also of vital importance to know about other possible factors which could negatively impact the excipient quality.
We encourage You to benefit from our experience, acquired during several years of company-specific consulting and employee training in the area of Good Storage Practice.
- Risk-based identification and definition of qualification and validation activities needed
- Qualification and validation for storage facilities, including set-up of monitoring (where requested, service includes provision of temperature loggers)
- Transport validation
- Cold chain validation including holding times
- Preparation of cost-efficient plans for monitoring of storage facilities