1.0 PURPOSE:
2.0 SCOPE:
This procedure is applicable for retain the specimen proof with batch packing record in production department at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Production operator is responsible to follow the procedure.
4.2 Production officer/executive is responsible for execution of the procedure.
4.3 IPQA officer/executive is responsible for verification of overprinted specimen proofs.
4.4 Head – Production is responsible to ensure the compliance of the SOP.
5.0 PROCEDURE:
5.1 Retaining of overprinted specimen proof with BPR:
5.1.1 After machine setting production operator shall give the first overprinted specimen proof of batch details for individual item.
5.1.2 Retain the overprinted proof of Blister / Alu foil at the start of batch, at the end of batch, at the start of activity in subsequent day, whenever required after machine setting and any change in A.R.No. with certification of production and IPQA officer/executive.
5.1.3 Retain the overprinted proof of printed labels of bottles/vials at the start of batch, at the end of batch, at the start of activity in subsequent day, whenever required after machine setting and any change in A.R.No. with certification of production and IPQA officer/executive.
5.1.4 Retain the overprinted proof of inner carton at the start of batch, at the end of batch, at the start of activity in subsequent day, whenever required after machine setting and any change in A.R.No. with certification of production and IPQA officer/executive.
5.1.5 Retain the overprinted proof of outer carton at the start of batch, at the end of batch, at the start of activity in subsequent day and, whenever required after machine setting any change in A.R.No. with certification of production and IPQA officer/executive.
5.1.6 Retain the overprinted proof of carton label (inner/outer) at the start of batch, at the end of batch and whenever required after machine setting with certification of production and QA officer/executive.
5.1.7 Retain the overprinted proof of shipper label at the start of batch and whenever required after machine setting with certification of production and IPQA officer/executive.
5.2 Retaining of specimen proof for printed packing materials with BPR:
5.2.1 Retain the overprinting proofs of printed packing materials with BPR as follows during operation of packing line.
5.2.2 Retain the overprinting proof of printed Alu foil at the time of Roll change with the certification of production officer/executive.
5.2.3 Retain the overprinting proof of printed label for bottles/vials at the time of Roll change with certification of production officer/executive.
5.2.4 Retain the overprinting proof of printed inner/outer cartons at the time of excess material consumed with certification of production and IPQA officer/executive.
5.2.5 Retain the proof of printed leaflets/booklet at the start of batch, at end of batch, at the start of activity in subsequent day and any change in A.R.No. with certification of Production and IPQA officer/ executive.
Note: 1. The first specimen proof of batch shall check and verify by production officer/executive and then certified by IPQA officer.
2. In case of any excess material consumed then the same should be certified by production and QA officer.
6.0 ABBREVIATIONS:
OSD :Oral Solid Dosage
QA :Quality Assurance
SOP :Standard Operating Procedure
BPR :Batch Packing Record
IPQA :In-process Quality Assurance
A.R.No. :Analytical reference Number
ALU :Aluminium