Handling of Controlled Items in Production Area is prepared for the Production area of pharmaceuticals factory.
Handling of Controlled Items in Production Area OBJECTIVE
1.1 To lay down the procedure for handling of controlled items in the production area.
SCOPE
2.1 The scope of this SOP pertains to the handling of controlled items in the tablet section of the production area.
RESPONSIBILITIES
3.1 It is the responsibility of Supervisor (Tablet) to follow this SOP as it is written.
3.2 It is the responsibility of Production Pharmacist (Tablet) to ensure that this procedure is followed in its entirety.
3.3 It is the responsibility of QAO to verify that this SOP is properly followed in its entirety.
3.4 It is the responsibility of Production Manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary.
4.0 DEFINITIONS & ABBREVIATIONS
4.1 SOP: Standard Operating Procedure
4.2 API: Active Pharmaceutical Ingredient
4.3 QAO: Quality Assurance Officer
MATERIALS & EQUIPMENTS
5.1 Transfer trolley
PROCEDURE
6.1 Handling of Controlled materials
6.1.1 Check the quantity of controlled API as per batch order.
6.1.2 Check sealed polythene bag has identification label containing product name, batch number, batch size, required quantity per batch, Lot number of API, In-house reference number, manufacturing date of lot and expiry date of lot.
6.1.3 Transfer the dispensed controlled material to production area through transfer trolley designated for controlled items, under lock and key.
6.1.4 Do not open the polythene bags of dispensed material before use.
6.2 Handling of Controlled Products In Process
6.2.1 Keep all the products in tightly sealed containers in quarantine and attached identification label containing product name, batch number, batch size and manufacturing stage.
6.2.2 On approval for release of respective stage by Q.C laboratory transfer sealed S.S containers to next steps.