1 Cold-storage drug manufacturers should have and be able to issue temperature and humidity stability data to support the storage and transportation of cold-storage drugs; suppliers and cold-chain logistics providers should provide sellers with temperature and humidity stability data issued by cold-storage drug manufacturers.
2 Refrigerated drug production, operation, use of units as well as undertake refrigerated drugs cold chain logistics storage, transportation temperature is always controlled within the prescribed range. Enterprises need to configure reliable facilities and equipment and transportation conditions to ensure that refrigerated drugs from production to use before
3 The cold chain system involves facilities and equipment and transportation routes, etc. must be verified, confirmed and approved before being put into use; facilities and equipment and transportation routes need to be changed, they must be verified, confirmed and approved again before being used.
4 Involved in the production, operation and use of refrigerated medicines, as well as the cold chain of refrigerated medicines logistics companies must establish a comprehensive cold chain management system for refrigerated medicines, including emergency response plans for temperature anomalies.
3. General Requirements for Validation
1 The relevant links of the cold chain, such as warehouse, facilities, equipment, vehicles, heat preservation packaging and monitoring instruments should be validated and confirmed, and written documents should be formed.
2 A Cold Chain Validation Master Plan should be developed to identify the validation and verification work that needs to be carried out, based on the level of risk and impact, in order to demonstrate that the critical parts of their particular operation are controllable and are guaranteed to be maintained in good condition.
3 A validation program should be developed, reviewed, and approved based on the object of validation. The validation program should specify the responsibility for implementing the validation.
4 Validation should be implemented in accordance with the pre-determined and approved program; after the completion of the validation work, a validation report should be written, and the deviations in the validation process should be assessed, and then reviewed and approved. Validation results and conclusions (including evaluation and recommendations) should be recorded and archived.
5 Validation and validation should take into account ambient temperature variations, refrigerated drug stability data, information related to transportation or distribution, and the design of packaging components.
6 According to the results of the validation should be revised transportation procedures, standard operating procedures, packing standards and shipping procedures.
7 If the use of electronic records as a form of data storage, should meet the data can not be changed, can be exported and other requirements, and to carry out the necessary verification, for automated control systems should also be verified.
8 Any change in product characteristics, internal and external packaging, transportation routes, climate change, etc., should be re-validated through the change control.
9 Cold storage, cold chain facilities and equipment, and the least desirable transportation processes should be reassessed and re-examined on a regular basis to ensure that they are capable of achieving the desired results.
10 All inspections should be performed every few years.