In-process Checks During Packing Operation

In-process Checks During Packing Operation

1.0 Objective
To lay down a procedure for In-process checks during packing operation.
2.0 Scope
This Standard Operating Procedure is applicable for In-process checks during packing

operation to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer/Executive QA and Officer/Executive Production shall be responsible for

In-process checks of all the packing operations.
3.2 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
BPCR : Batch Production and Control Record
RH : Relative Humidity
MRN : Material Return Note
No. : Number
Mfg : Manufacturing
Exp : Expiry
QA : Quality Assurance
MRP : Maximum Retail Price
5.0 Procedure
5.1 Officer/Executive QA shall ensure followings points before start of any stage of packing
Operations.
5.1.1 Packing area shall be cleaned as per current version of respective specified SOP.
5.1.2 All the equipment shall be cleaned as per current version of respective specified SOP.
5.1.3 Temperature and RH shall be recorded in the BPCR as per respective specified SOP.
5.1.4 Line clearance of packing area shall be carried out as per respective specified SOP.
5.1.5 Equipment log of the area shall be filled correctly and completely at every stage.
5.1.6 All the weighing balances shall be calibrated as per respective specified SOP.
5.1.7 All intermediate process containers of areas and equipments shall be identified by status labels.
5.1.8 Differential pressure of the areas shall be within the limit and shall be recorded as per respective specified SOP.
5.1.9 Officer/Executive QA shall ensure that In-process checking for each packing operation shall be performed.
5.2 Stage: Printing – Officer/Executive QA shall check the following points:
5.2.1 Check the material taken for Packing of Product shall be as per BPCR.
5.2.2 Verification of Packing Material against Bill of Material.
5.2.3 Verification and approval of the specimen by signing with green ink for

Batch No., Mfg. Date, Exp. Date, Mfg. licence number / neutral code (where applicable)

and other additional information check with BPCR and MRP against Price list.
5.2.4 Ensure the printing details along with the specimens shall be filled in BPCR before it reaches the packing line.
5.2.5 Ensure the Coded / Uncoded Printed Packing, shall be placed separately on pallets / trolleys / racks with status label.
5.3 Stage: Blisters /Strips/ Bottles / Vials Packing
5.3.1 Officer/Executive QA shall check all the parameters mentioned in point number 5.1.
5.3.2 Officer/Executive QA shall ensure that processing is carried out in accordance with BPCR.
5.3.3 Officer/Executive QA shall check the following parameters for compliance:
5.3.3.1 Sealing / Blister forming temperature of the machine.
5.3.3.2 Leak test of the Strips / Blisters / bottles / vials as per respective specified SOP No.QA/030.
5.3.3.3 Overprinting on the Strips / Blisters / bottles / Vials.
5.3.4 Officer/Executive QA shall check all the parameters as specified in record as per the frequency in the BPCR in green ink.
5.4 Stage: Packing line
5.4.1 Officer/Executive QA shall check all the parameters mentioned in point 5.1.
5.4.2 Officer/Executive QA shall check that product is being packed online in accordance with BPCR.
5.4.3 Officer/Executive QA shall check the strips/ blisters/ bottles/ vials coming out of

the machine shall be inspected on the belt for defects and for the overall appearance as follows:
5.4.3.1 Strips/ Blisters/ bottles/ vials for Product identity.
5.4.3.2 Overprinting quality shall be checked on samples equal to number of stereo sets on the machine.
5.4.3.3 Physical defects like; Misprint / ink smudge in batch Coding, Missing

Tablets/ Capsules / Empty pockets / Broken Tablets / open Capsules in

Pockets / Improper Sealing / Cuts / Scoring on the foil / Label on the bottles / Cracks vials.
5.4.4 Officer/Executive QA shall check pack details on cartons for:
5.4.4.1 Correctness of coding details on cartons Batch No., Mfg., Exp. Date and Retail Price.
5.4.4.2 Over printing
5.4.4.3 Quantity of strips/ blisters.
5.4.5 Officer/Executive QA shall check all the above parameters and record

in green ink in BPCR as frequency mentioned.
5.4.6 Officer / Executive shall collect the control samples as per the specified

SOP and other samples (if required); record the details in BPCR of respective product in green ink.
5.4.7 Officer / Executive shall ensure that the details of de-foiling shall be recorded in BPCR by Packing Department.
5.4.8 Officer/Executive QA shall check the shippers for:
5.4.8.1 Its correct size.
5.4.8.2 Quantity of shrink wrapped bundles.
5.4.8.3 Details recorded on the label.
5.4.8.4 Packed shipper of each product / batch wise is placed on the separate pallets.
5.4.9 After ensuring the above, Officer/Executive QA shall sign on the

format of In-process checks in BPCR with green ink.
5.4.10 Officer/Executive QA shall ensure the completion of on-line

documentation in the BPCR up to the packing stage.
5.5 Shipper weighing / printing / labelling / transfer slip
5.5.1 Officer/Executive QA shall check the compliance of weight of

shippers and its entry in BPCR by Packing Department.
5.5.2 Officer/Executive QA shall ensure the details of correct shipper label for printing of:
5.5.2.1 Product
5.5.2.2 Batch coding (batch number, manufacturing date and quantity)
5.6 In case if any discrepancy is observed in the Process / Document / Environmental
parameter, QA inform the same immediately to the concerned person / respective area In-
charge and also Head QA.
5.7 Record the details of In-process checking in green ink in checklist attached with BPCR of
the respective product as per respective specified SOP.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance and Production
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Reason for Revision

Leave a Comment Cancel reply