Version No.

1
Title:

Document No: SOP for Packing of Tablets/Capsules in Primary Page No.

SOP/OS/022 Page 1 of 5
Packing and Secondary Packing

Effective Date Revision Date

SOP for Packing of Tablets/Capsules in Primary Packing

and Secondary Packing

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z

Department Name Date

 Version No.
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Title:

Document No: SOP for Packing of Tablets/Capsules in Primary Page No.

SOP/OS/022 Page 2 of 5
Packing and Secondary Packing

Effective Date Revision Date

1. Purpose
This procedure defines the procedure for Packing of Tablets/Capsules in strip pack or blister
pack as primary packing & packing of strips or blisters in cartons, shipper as secondary
packing.

2. Scope
This SOP shall be applicable for all the primary & secondary packing operations in Packing
area at Production department in

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the operator and production supervisors to follow the
procedure. Quality assurance manager is responsible for SOP compliance.

5. Material and Equipment

None

6. Procedure

6.1. PRIMARY PACKING

6.1.1. Ensure that primary packing area is cleaned & free from any leftover of previous
product / batch.
6.1.2. Note down the temperature and humidity in the primary packing area.
6.1.3. Bring the dispensed quantity of foil from Tablet store II room for the respective
batch.
6.1.4. Set the strip packing or blister packing machines for the required product to be
packed.
6.1.5. Ensure that the area is certified by QA person according to the standard operating
procedure for line clearance.
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Packing and Secondary Packing

Effective Date Revision Date

6.1.6. Receive the overprinting stereos from the Pharmacist & set the overprinting
matter on overprinting unit.
6.1.7. The Pharmacist should refer the Batch Packing Record for Manufacturing Date,
Expiry Date. For Retail Price, refer the price list issued from Q.A. while giving
the overprinting instructions to the operator & in process checks. The latest
version of authorized price list should be referred during printing.
6.1.8. Take the containers of the product to the area. Ensure and Check status label on
containers for correct product name, B.No., container nos. etc & release status of
the batch. Check that the tablets are inspected. Use the product containers serially
as per the container numbers on the label.
6.1.9. Start the strip / blister packing machine after appropriate settings of m/c. for
required temp., speed, etc.
6.1.10. Perform the initial leak testing with No. of Strips / blisters indicated in the batch
record & record the results. If leak test and other parameter is satisfactory,
Continue the packing process.
6.1.11. At initial stage, open few initial strips & observes the tablets for appearance of
tablets change in color shade, change in branding quality, physical defect of
tablets etc. if any. Also check the strips/blisters for appearance, printing clarity,
cut pocket, vertical as well as horizontal cutting etc.
6.1.12. In case of collator machine, whenever the machine is stopped in between & again
started, strips/blister should to be checked for correct number of tablets in each
strip, cut pocket etc.
6.2. BLISTER /STRIP CHECKING DURING PACKING
6.2.1. Strip checking person should inspect for empty pocket, and pocket cut, half
broken tablet (in case of blister) and remove defective strip or blister if any.
6.2.2. The person should check the printing for clarity and smudging and appearance of
strip and remove defective strip or blister if any.
6.2.3. Checking person should collect the defective strip or blister in a duly label
container as “Rejected”.
6.2.4. The counting person should count the required no. of blister, and send it to carton
filling person.
6.3. SECONDARY PACKING
6.3.1. Before starting of the batch, line clearance of packing belt and area should be
carried out.
6.3.2. Previously overprinted packing material should be ready near the packing belt.
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Packing and Secondary Packing

Effective Date Revision Date

6.3.3. Packing pharmacist should display Details of B.No. Mode of Packing, M.R.P.,
Mfg. /Exp. Etc. on the agminated/status label display board for status of packing
operation by referring the BPR.
6.3.4. Carton filling person should check the carton for over printing, intactness; He/she
should open the carton and insert the leaflet if required with counted strips.
6.3.5. Carton closing person should close the carton and arrange the carton for
weighing.
6.3.6. Carton weighing person should carry out the weighing of individual cartons.
He/she will check the carton against the weighing range. If he/she found any
variation beyond the range, he/she will keep it aside for checking & inform the
pharmacist for verification.
6.3.7. The weight of every carton is to be done. The weighed carton will be packed in
shipper by shipper packing person. He/she will arrange the carton in layer and
then fill it in box, till the required configuration is achieved.
6.3.8. A specimen for stenciling required to be done on shipper should be prepared &
checked by stenciling operator & then authorized by Pharmacist, Approved QA
person. After the approval, shipper should be stenciled. Signed specimen to be
attached with respective BPR.
6.3.9. After filling the Box, the Box will be sealed and labeled. The sealed boxes will
be weighed and weight will be recorded in a “Shipper weighing Record”.
6.3.10. Collect all rejected strips/blisters in an appropriately labeled container till such
strips/blisters are defoiled. All defoiled tablets to be inspected for any broken
tablets or tablets with damaged appearance & pieces of foil. All broken, chipped,
capped tablets are kept as utilizable residue.
6.3.11. After complete inspection of tablets at the end of the batch, Pharmacist should
check the good tablets and then these tablets can be repacked if required and
mentioned it in the BPR as defoiled tablet packed.
6.3.12. After filling the specified quantity of cartons in to shipper, shipper packing
person, Pharmacist should sign the checking slip. The checking slip will have
details of Product Name, Qty., B.No. Box No., Checked by, Packed by etc.
6.3.13. The signed checking slip will be pasted inside the shipper flap & then the line
leader should sign the pasted checking slip.
6.3.14. Shipper should be sealed with ‘BOPP’ tape issued for the batch.
6.3.15. Finished goods should be transferred to BSR with a note in prescribed “Finished
goods transfer note”.
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Packing and Secondary Packing

Effective Date Revision Date

6.3.16. Left over unused printed foil & plain foil or PVC film should be returned to
stores, & should be recorded in BPR. Any other material like leftover or rejected
overprinted cartons, catch covers, labels, stenciled shipper, leaflets etc. should not
be returned to stores or it should be destroyed and mention in the reconciliation
page of BPR.
6.3.17. While sending the foil rolls to stores, each roll should be cleaned with a dry lint
free cloth from all sides. Approximate 1 to 2 meters of foil should be removed &
destroyed. All the rolls returned from shop floor should be wrapped in a poly bag
& should be duly labeled and sign.
6.3.18. Non-recoverable product residue should be disposed off by putting it to the water
as in process waste. Utilisable residue generates if any should be kept with proper
label & sign of pharmacist and competent staff.
6.3.19. Disposal of overprinting stereos should be done by cutting & then further
disposal.
6.3.20. Reconciliation of product, packing material & finished goods should be done in
the batch documents after completion of packing.
6.3.21. Batch manufacturing record completed in all respects should be submitted to Q.A.
for release of the batch for further process.
7. Abbreviations:
SOP: Standard Operating Procedure
BPR: Batch Packing Record
Q.A.: Quality Assurance
8. Related Documents /Applicable document/
None
9. Revision History

Version
Revision Description
No.

1 New