SOP For In-Process Checks on Blister Packing Machine is described in this post which you can follow in the section of the Quality Assurance Department.
OBECTIVE
This procedure has been established to outline for in process inspection to be conducted during blister packing to ensure the quality of product.
SCOPE
This procedure is applicable to the Production Department of blister packing area
RESPONSIBILITY
QA Officer
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
QA Officer checks the cleaning status of the machine to ensure that the hopper and channels are properly cleaned and do not contain any tablet or capsule.
QA Officer checks and ensures that machine and adjacent area is free from the remains of previous product.
QA Officer checks the digits i.e. Batch No., Exp. Date for accuracy against MO.
QA Officer ensures that approved label issued by QC affixed on the machine.
QA Officer checks that strip meets the regulatory requirements i.e. product name, generic name Reg.No., Mfg.Lic No., dosage, strength and complete address of the company.
QA Officer collects 6 empty blister strips for leak test.
After approval of leak test, QA Officer issue line clearance for blistering.
QA Officer checks five filled blister strips or strips no. per stroke for leak test.
QA Officer ensures the leak test for blister strip during blistering.
After this QA Officer observe the cutting, printing, alignment, finishing of blister and perforation, if any. These parameters must be satisfactory and should be carried out during the whole process of blistering
QA Officer also checks ‘’CHECK LIST FOR BLISTERING’’ for the correctness of the product to be blistered.
It must be completed and signed by the packing officer.
After complete verification of all parameters QA Officer sign check list.
The check list must be singed whenever the process is started by packing and QA Officers.