If Raw Material Dispensed for Batch Manufacturing On 08/2019 and Manufactured On 09/2019,
Then Manufacturing Date shall be 08/2019 or 09/2019,…
Manufacturing Date shall be 08/2019. Because Dispensing is the first stage of Manufacturing process. So Shelf life will be started from first date of manufacturing process.
Shelf life starts when API n exceptients are converted into dosage form n it is applicable when manufacturing starts in a manufacturing area so mfg will be 09/2019
The Date of Manufacture for a given batch of drug product is the date on which processing is initiated; for example, when the Active Pharmaceutical Ingredient (API) is mixed with, or added to the other materials.
some companies may use the procedure starting from dispensing but best practice is as follow
A Drug Product having a commercial expiry date of 2 years (which start the Date of Manufacture e.g. weighing, or best case, with justification, combining of the API with excipients
So is it vary from company to company SOP? But have any regulatory guidelines for this issue?
Dear Shruthispoorthy ,Please notice that Based on EU regulation he date of production of a batch is defined as the date that the first step is performed involving combining the active ingredient with other ingredients. For medicinal products consisting of a single active ingredient filled into a container, the initial date of the filling operation is taken as the date of production. (Ref: EMEA/CVMP/453/01).
the same thing i was argued with my Qa manager but finally he said 08/2021.because during dispensing chemical state of API/Excepients will be change then from that mfg date will be desided, but still im not agree with him.
Hey filling is a part of packing(Primary), Here im asking about Manufacturing.
After dispensing chemical state is not changed.e…g After dispensing metformin hcl remain metformin hcl we just weigh qty acc to MO from main containers.same for excipients like starch etc hold its original characteristics no chang we just maintain Temp RH etc in staging area im range.
ha sir that is why still i cant accept his decision ,so finally is it 09/2019 sir…
yes final is 09/2019 with logics and justifications mfg start when we mix API with excipients
k sir tq
When the manufacturing is completed that is the manufacturing date, but not the denspensing date as manufacturing date.
Hence 09/2019 is manufacturing date
thanks for the response to everyone…
kk got it tq