Temperature monitoring / control.
The stability of the products through temperature control is of great importance to the roll Phardiag plays in the supply chain. In order assure the stability of the product it must remain within the temperature specifications (see appendix 1 for list of our temperature requirements for our products).
To achieve this Phardiag must ensure that the product is delivered to us as per the temperature specification. We achieve this by having SLA with our suppliers to transport the goods temperature controlled and we also place a Berlinger TM. Single use data logger with the goods so the temperature can be verified on arrival in Phardiag whether the goods are transported by Road, Sea or Air, We also risk asses the …show more content…
The product is placed into one of these warehouses depending on the specs. We have mapped our warehouses in winter and summer months to identify hot and cold spots in accordance with WHO (World Health Organization) guidelines “Temperature mapping of Storage areas” available at http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf. We have set our probes to alarm at a temperature before they go out of spec and the logistics manager and I will get a text message advising us of an alarm so we can move the product if we receive an alarm before it goes out of spec. We use Rototherm data …show more content…
Outlining how the product should be handled, stored and transported from supplier to Phardiag, from Phardiag to toll manufacturing site and from toll manufacturing site to our customer the regional distribution centres. These SLA’s and quality agreements form an integral part of our quality assurance. The technical data and product specifications are also included in these agreements.
Incoming inspection in Phardiag
Active Pharmaceutical Ingredients - When we receive API’s into Phardiag we cannot open or test the product as we do not have a licence to open or test API’s. So when we receive the goods into Phardiag the warehouse operator will check the labels on the API’s for lot number and quantity of batch match the paperwork received from the supplier, we check the seals and the integrity of the packaging, we check the paperwork and labels against the p/o . We check a percentage of the total delivery using AQL sample size 11 and we check the CoA’s and CoC’s according to our internal SOP. We also have similar inspections for Bulk tabs and Diagnostic Vials. (see appendix 2 Active Ingredient Verification Record) ( more on AQL sample sizing see
The stability of the products through temperature control is of great importance to the roll Phardiag plays in the supply chain. In order assure the stability of the product it must remain within the temperature specifications (see appendix 1 for list of our temperature requirements for our products).
To achieve this Phardiag must ensure that the product is delivered to us as per the temperature specification. We achieve this by having SLA with our suppliers to transport the goods temperature controlled and we also place a Berlinger TM. Single use data logger with the goods so the temperature can be verified on arrival in Phardiag whether the goods are transported by Road, Sea or Air, We also risk asses the …show more content…
The product is placed into one of these warehouses depending on the specs. We have mapped our warehouses in winter and summer months to identify hot and cold spots in accordance with WHO (World Health Organization) guidelines “Temperature mapping of Storage areas” available at http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf. We have set our probes to alarm at a temperature before they go out of spec and the logistics manager and I will get a text message advising us of an alarm so we can move the product if we receive an alarm before it goes out of spec. We use Rototherm data …show more content…
Outlining how the product should be handled, stored and transported from supplier to Phardiag, from Phardiag to toll manufacturing site and from toll manufacturing site to our customer the regional distribution centres. These SLA’s and quality agreements form an integral part of our quality assurance. The technical data and product specifications are also included in these agreements.
Incoming inspection in Phardiag
Active Pharmaceutical Ingredients - When we receive API’s into Phardiag we cannot open or test the product as we do not have a licence to open or test API’s. So when we receive the goods into Phardiag the warehouse operator will check the labels on the API’s for lot number and quantity of batch match the paperwork received from the supplier, we check the seals and the integrity of the packaging, we check the paperwork and labels against the p/o . We check a percentage of the total delivery using AQL sample size 11 and we check the CoA’s and CoC’s according to our internal SOP. We also have similar inspections for Bulk tabs and Diagnostic Vials. (see appendix 2 Active Ingredient Verification Record) ( more on AQL sample sizing see