Approval of Overprinting on Packing Material
1.0 Objective
To lay down a procedure for approval of overprinting of packing material.
2.0 Scope
This Standard Operating Procedure is applicable for approval of overprinting of packing material
of all departments to be followed at formulation plant abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for verifying and giving line clearance for overprinting of packing material.
3.2 Head / In charge, Quality assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
BPCR : Batch Production and Control Record
MRP : Maximum Retail Price
5.0 Procedure
5.1 On receiving the intimation from production regarding line clearance for
overprinting of packing material, QA shall first ensure the following points, after
compliance of these points line clearance shall be given for overprinting.
5.1.1 Cleanliness of overprinting area and machine
5.1.2 Absence of remnants of the previous material in the area and machine.
5.1.3 Stereos of overprinting shall be handled as per production SOP title
“Issuance and destruction of stereos”.
5.1.4 Quality Control approval of packing materials to be overprinted.
5.1.5 After assuring the above points, QA shall give line clearance for overprinting of
packing materials and allow to transfer the materials to be overprinted in the overprinting area.
5.2 Operator shall first check the overprinted specimen from BPCR like
batch no. , Mfg. Date, Exp. Date, MRP, any other details.
5.3 In case of overprinting on aluminum foil, the impression of
stereos shall be taken on one cycle of a roller.
5.4 Production officer / Executive shall first sign on the overprinted
specimen after checking the all details.
5.5 QA Officer / Executive shall verify the overprinting details from
BPCR and finally authorize for the overprinting.
5.6 QA Officer / Executive shall attach the approved overprinted specimen
in the BPCR at the space designated for the same.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid