SOP on Batch Coding Details Authorization
1.0 Purpose: This SOP describes the procedure for authorization of Batch Coding details.
2.0 Scope: This SOP is applicable to all drug formulation batches manufactured in the company.
3.0 Responsibility: Production supervisor to ensure that procedure is followed.
4.0 Materials and Equipment: As & when required.
5.1 As per the production planning, drug formulations batches are manufactured. Each scheduled manufactured batch is assigned a sequential batch number, M/D, E/D. MRP etc. (as applicable) and any other special instructions for the specific product.
5.2 To print the above mentioned information, rubber stereos are ordered as per SOP# PD-32 in case of labels & strips and for unit cartons batch coding data is manually set up in frame of motorised batch coding machine.
5.3 Batch Coding section is provided with standard quantity of packaging material(s) required along with details to be coded.
5.4 First two coded labels or cartons are checked for correctness of printing quality and signed by production supervisor & quality control chemist.
5.5 In case of automatic printing & labeling machine, approved stereos are issued and first two coded labels are checked for correctness of printing quality and signed by production supervisor & quality control chemist.
5.6 For strip packing, approved stereos are issued to packing department. After setting stereos on roller of machine, correctness of printing quality on foil is checked and signed by production supervisor & quality control chemist.
5.7 Coded specimen are kept in batch production record and in coding section.