Follow
Objective: To lay down procedure for codification of material and issuance.
Scope: This SOP shall applicable to Quality Assurance Department of (Company Name).
Responsibility: Officer/Manager of Quality Assurance Department.
Procedure:
=>> All the material such as raw material (Active and Excipients), packing materials, active materials/impurities CRS standard and working standard shall be coded with unique identification code number.
=>> Different code numbers shall be issued for different specifications as well as different sources of materials.
=>> Quality Assurance Department shall allocate the identification code for the new material after getting the request from the user department as per the annexure – I.
=>> All the Raw materials (Active Pharmaceutical Ingredient) shall be allotted seven digit numeric sequential number starting with series, 1000000. First material under this category shall be given the identification code as 1000000 and subsequently followed by the serial number 1000001, 1000002 and so on. To distinguish APIs from different sources/suppliers, all the material and product related documents (e.g. BMR, BPR, Specification, MRR, Release documents, Material labels etc) will bear item code suffixed with the specific supplier ID number.
=>> All the Raw material (Inactive/Excipients) shall be allotted seven digit numeric sequential number starting with series, 2000000. First material under this category shall be given the identification code as 2000000 and subsequently followed by the serial number 2000001, 2000002 and so on. Any excipient which is used also as active in some formulation e.g. Calcium Carbonate etc. shall have the code starting 2.
=>> All the Intermediate (Semi finished product) shall be allotted seven digit numeric sequential number starting with series, 3000000. First material under this category shall be given the identification code as 3000000 and subsequently followed by the serial number 3000001, 3000002 and so on.
=>> Packing material for all type of foils & films (aluminium printed and plain, PVC, PVDC, Paperback etc.), Aluminium can & Metering valve shall be allotted seven digit numeric sequential number starting with series, 4000000. First material under this category shall be given the identification code as 4000000 and subsequently followed by the serial number 4000001, 4000002 and so on.
=>> All type of printed Packing material which includes Shipper, Inner cartoon, Catch covers, Leaflets, Labels etc. shall be allotted seven digit numeric sequential number starting with series, 5000000. First material under this category shall be given the identification code as 5000000 and subsequently followed by the serial number 5000001, 5000002 and so on.
=>> All Plastic packing materials (Plastic actuator with dust cap, Dust cap, Collar etc ) shall be allotted seven digit numeric sequential number starting with series, 6000000. First material under this category shall be given the identification code as 6000000 and subsequently followed by the serial number 6000001, 6000002 and so on.
=>> All miscellaneous item which includes BOPP tape (Pre printed or plain), Holographicsticker, Strap, Metal seal etc. shall be allotted seven digit numeric sequential number starting with series, 7000000. First material under this category shall be given theidentification code as 7000000 and subsequently followed by the serial number 7000001,7000002 and so on.
=>> All Active material/Impurities CRS standard shall be allotted seven digit numeric sequential number starting with series, 8000000. First material under this category shall be given the identification code as 8000000 and subsequently followed by the serial number 8000001, 8000002 and so on.
=>> All Working standards shall be allotted seven digit numeric sequential number starting with series, 9000000. First material under this category shall be given the identification code as 9000000 and subsequently followed by the serial number 9000001, 9000002 and so on.
=>> All the Finished product code will be followed as provided by planning department.
=>> Separate log book to be maintained for issuance of code for each series as per the annexure-II.
=>> Issuance of code number shall follow:
=>> Approved photocopy of the annexure-I shall be distributed to the requested department with entry in the log book and the original should be retained with QA for reference purpose.
=>> Revision of the codification of material shall be done as per the document control procedure (SOP No.: QA002).
