With the changing regulatory landscape for the storage and distribution of temperature-sensitive products, we provide and execute audit ready protocols and reports that are designed to comply with:
11.4.1. The following should be validated as a minimum: (a) Warehouse premises: ambient and cold-chain storage conditions including temperature mapping; (b) Lagged containers; (c) Cold-chain processes; (d) Computerised systems; and (e) Transportation systems
188.8.131.52. (a) Packaging system of thermolabile pharmaceutical products, for purposes of distribution must be quality assured to ensure that it occurs within the cold room environment, fulfils the manufacturers’ specifications requirements, is thermally designed and validated, and is related to Temperature Profile(s)/Logistic history.
14.3.3. All warehouses should be temperature mapped over a period of at least one year to determine the temperature distribution under seasonal extremes.
184.108.40.206. (c)The storage area must be kept clean. Internal air temperature distribution must be mapped on installation of the storage area while empty and thereafter fully stocked. This must be done annually under conditions of normal use. Thermo labile pharmaceutical products must not be stored in areas shown by temperature mapping to present a risk (e.g. in the airflow from the refrigeration unit).
15.1 All pharmaceutical products should be stored and distributed in shipment containers which do not have an adverse effect on the quality of the products, and which offer adequate protection from external influences, including contamination.
15.6 Validated Lagged Container.
15.6.1 Thermolabile products are normally transported in lagged containers. During transportation these products must be protected by insulated packaging.
15.6.2 There should be a written procedure available for the validation of the lagged containers.
(h) Temperature data loggers, refrigeration tags, freezer tags, log tags or cold chain monitoring cards that complies with or meets WHO specifications must monitor the temperature of the loaded area of the transportation throughout the trip, and the validated cooler box packaging must have at least a temperature monitoring device that complies or meets with WHO specifications.
(c) In the event of the mode(s) of transport not being specific for the transportation of thermolabile pharmaceutical products, the specialised packaging like validated cooler bag packaging must be used.
14.4.5. Monitoring equipment should be calibrated once a year.
220.127.116.11. (l) Any recording devices/instruments must be calibrated annually against a certificated standard.
14.5.7. Good storage practices and loading configurations should not lead to the obstruction of air distribution; e) Have sensors for continuous temperature monitoring and alarms located at the points representing the temperature extremes.
18.104.22.168. (h) Temperature data loggers, refrigeration tags, freezer tags, log tags or cold chain monitoring cards that complies with or meets WHO specifications must monitor the temperature of the loaded area of the transportation throughout the trip, and the validated cooler box packaging must have at least a temperature monitoring device that complies or meets with WHO specifications.
10.1.1 All personnel involved in wholesaling or distribution activities should have the education, training, experience or combination of these elements that will allow them to effectively discharge this responsibility and be capable of meeting these requirements. This training should be documented.
(g) Personnel should receive initial (induction) and continuing training relevant to their tasks, and be assessed as applicable, in accordance with a written training program
(a) All persons involved in the procurement, storage and distribution of thermolabile pharmaceutical products must have the education, training, experience or combination of these elements that will allow them to effectively discharge this responsibility and be capable of meeting these requirements. This training must be documented.
11.7.2 Effective Risk Management allows the risks to be controlled to such an extent that the unwanted subset of a set of uncertain outcomes can be mitigated adequately.
11.7.4 Risk assessment plays a crucial role in not only security management, but also in ensuring delivery of consistent quality service in the healthcare supply chain. In this environment it equates to quality pharmaceutical products delivered to the correct customers, under the correct storage and transportation conditions.
11.7.5 Wholesalers should annually conduct risk assessments to assess potential risks to the quality and integrity of pharmaceutical products. The quality system should be developed and implemented to address any potential risks identified. The quality system should be reviewed and revised annually to address new risks identified during a risk assessment.
22.214.171.124 A distribution system must have in place: (d) a risk assessment programme.