SOP on Reprocessing of Materials
1.0 Purpose: This SOP describes a method for the reprocessing of materials.
2.0 Scope: This SOP applies to Production Chemist.
3.0 Responsibility: Production Manager to ensure that procedure is followed.
4.0 Materials and Equipment: As and when required
5.0 Procedure:
5.01 On receipt of request from finished goods stores, check whether product is to be reprocessed on account of spoiled labels, damaged labels or other packaging reasons.
5.02 After getting approval from Qaulity Control Department for relabelling / repacking, product can be relabelled or repacked and record the proceedings.
5.03 If product is to be reworked, record following –
a. name and strength of product.
b. batch no.
c. date of manufacturing
d. date of expiry
e. quantity to be reworked
5.04 Send a representative sample to Quality Control laboratory for analysis. On receipt of sample in Quality control laboratory, examine visible appearance of contents, evidence of deterioration etc. Then analyse representative sample according to specification laid down for said product and record the results.
5.05 If representative sample conforms to norms / specification, product may be reworked after getting approval by Quality Assurance Manager for –
a. safety evaluation
b. shelf-life is to be increased or assigned the same initial expiry date
c. if shelf-life is increased, then ensure that it should not be more than established shelf-life of the product or it should not be more than stated expiry for active or inactive raw materials.
6.0 Reason for Review:- Minor revision in format.