MKB PHARMACEUTICALS (Pvt) Ltd.

STANDARD OPERATING PROCEDURE.

(Not valid without signature)
Blistering & Packing of Document No MKB/PD/SOP/018
Effective date
Tablet and Capsule Revision No 01
Replaces Rev# - 00 Dated: 15-02-2007

Review schedule by QA/QCM with 1year 2year 3year 4year 5year 6year
Head of the Department.

Prepared by Reviewed by Approved by

1.0 Purpose
The purpose of this document is to provide a written procedure for the Blistering and
Packing of tablets and capsules in Tablet & Capsule Packing Section dedicated for
Blistering and Packing. The document only covers the systematic procedure to be followed
for working while packing protocols for each product is given in relevant BMP.

2.0 Scope
This procedure is applicable to the Blistering and Packing of tablets and capsules including
various groups of products like antibiotics and general products in dedicated sections for
Tablet and Capsule Packing of MKB Pharmaceuticals (Pvt) Ltd.
3.0 Terms and definitions
Terms Definitions
PPEs Personnel Protective Equipments
BMP Batch Manufacturing Protocols
PT Packing Ticket
BPR Batch Processing Record
TT Finished Goods Transfer Ticket
RT Rejection Ticket
SOP Standard Operating Procedure
MSDS Material Safety Data Sheet
NCR Non Conformance Report
D&RC Documentation & Record Control
QA/QC Quality Assurance/Quality Control
4.0 Responsibilities
• Manager Production: i-To implement the procedure in the department.
ii- To plan the production as per capacity of the departments keeping in view the
in-process batches, the marketing/institutional demand and set the priorities.

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 iii- To supervise all the production processes and suggest trouble shooting in case
any nonconformance.
iv- To ensure that the working in production department is as per written
procedures.
• Section In-charge: i- To perform and train the personnel according to written
procedures for the production of various products in the guidance of Manager
Production.
ii- To directly monitor all the production processes by following all the written
procedures.
iii- To prepare PT for the dispensing of Packaging Material and coordinate for the
printing of Packaging Material.
iv- To perform in-process checks in coordination with QA/QC like Correct Batch
Number, wrinkles in the blisters etc mentioned in the In-process Check Sheet.
v- To ensure that the Packing processes are performed as per protocols in the
relevant BMP and inform Manager Production in case any nonconformance for
trouble shooting.
vi- To conduct packing as per planning provided by Manager Production and keep
all the records updated.

5.0 Environment Safety and Health Precautions

• Use proper PPEs during handling various products.
• Use trolley for the transportation of heavy containers.
• Avoid direct contact to the Product and Raw Material.
• Always turn the machine off while working inside.
• Do not lubricate the running machine.
• Incase any material dropped in the eye; wash the effected eye with plenty of water.
• There is proper training of the personnel according to the MSDS of the active drug.

6.0 Procedure
6.1 General Precautions
• Keep the conditions controlled as mentioned in the relevant BMP.
• Always take the line clearance before starting any operation.

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 • Enter all the information in the relevant log book of the machine used.
• Immediately clean the machine as per relevant SOP after completing any
production operation.
• Always place the packed master carton over the pillod to avoid decay due to
accidental wetting or any other.
• Always properly seal the master carton with date and identification stamp.
6.2 Packing
The process of Tablets and capsules blistering and packing; starts after the release of a
batch for packing by QA/QC. The Section In-charge receives the Intimation from QA/QC
and archives in the relevant BPR. The tablet and Capsules blistering and packing Staff
perform the process of tablet blistering and packing in the supervision of Section In-
charge in the following way;
• The batch of tablets/capsules is shifted to the Blistering area along with relevant BPR;
the Section In-charge confirms the quantity and identification as per Identification
Slip.
• Required Blister Forming Die Set, Sealing set, Batch Number & Expiry Date Embossing
Figures & Digits and Cutter is installed over the machine as per specifications
mentioned in the relevant Master Formulae and BMP.
• Other relevant machinery and equipments is connected and cleaned like Compressed
air and chiller etc.
• The Packaging material is issued through PT.
• The Secondary Packaging Material after dispensing through PT as per SOP is shifted to
the Tablet & Capsule Packing.
• The Aluminum foil, PVC/PVDC/Forming Aluminum and other blistering material as per
requirements i.e. primary packaging material; are shifted to the Blistering area.
• The Packaging Material required printing is sent to the printing section and printed as
per SOP and specifications mentioned in the relevant BMP and Master Formulae. While
the material do not require printing is retained in the Packing Hall e.g. Leaf Inserts,
Measuring cups and Master Cartons etc.
• QA/QC Inspector is verbally informed for Line Clearance.
• QA/QC inspector inspects the Machinery and area to be used for proper cleaning,
removal of material used for previous product and other requirements as per product
requirements mentioned in the relevant BMP and issues Line Clearance.
• The forming and sealing blistering material is installed over the blistering machine.
• Machine is adjusted and a sample of empty blisters is produced is produced.
• QA/QC Inspector check the following and release the batch for ongoing process;
Correct Batch Number
Correct Expiry Date
Correct printed Aluminum foil
Correct Forming Material
Leakage Test
Proper cutting for both Printed Text and location of Batch Number and Expiry Date is
checked.
Physical appearance of the empty sealed blisters like wrinkles in the blister and any
damage due to machine etc is checked.
• The empty blister is signed by QA/QC Inspector and section In-charge and archived in
the relevant BPR.

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 • Tablets/Capsules are charged in the blistering machine and blistering is started.
• The blisters are traveling through conveyor belt and online sorting is performed.
• During the process if any parameter is out of limit the machine is stopped and
corrective action is taken.
• The tablets and Capsules Blistering and Packing process are performed as per written
protocols in the relevant BMP.
• In-process Inspection is done by section In-charge and QA/QC inspector and recorded
in the In-process Packing Control.
• In case additional quantity of any Primary or secondary packaging material is required,
it is issued using same PT.
• After completion of packing the Section In-charge prepare TT and send to the
Warehouse In-charge.
• The warehouse in-charge confirms the entries and quantity, signs the TT and shifts the
batch to Warehouse as per SOP.
• The BMP is completed, reconciled and audited; all the relevant information is also
entered in the Batch Record Sheet.
• Rejected material is sent to warehouse on RT. Incase the rejection percentage is
greater than 5%, NCR is prepared by Section In-charge dually signed by Manager
Production and the matter is investigated and preventive measures are taken for
future.
• PT is reconciled, the original is sent to warehouse and copy is archived in the BPR.
• QA/QC is intimated on Intimation to QA/QC for Test & Analysis and following
information is demanded;
Release for Marketing.
• QA/QC audit the relevant BPR complete in all aspects; the decision is conveyed
through the same intimation send by the production, by sending the copy to
Warehouse Department and archive the original in relevant BPR.
• The BPR is archived in the D&RC section, for two years after the expiry of the product.
• In case repacking of the same product is required for some specific
marketing/institutional demand or Returned product from the market; the product is
shifted to the packing hall, BPR is re-issued from D&RC and required packaging
material is issued on separate PT and proceed as above.

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7.0 References
Document No Description
MKB/WH/SOP/008 Receiving of Finished Goods from Production in Warehouse
MKB/WH/SOP/003 Placement and Movement of Material in Warehouse
MKB/WH/SOP/005 Dispensing of Packing Material from Warehouse
MKB/WH/SOP/002 Disposition of Rejected Raw and Packaging Material
MKB/WH/SOP/010 Handling of Returned/Recall/Short expiry and Expired Products
MKB/PD/SOP/008 Launching Of New Product in Production
8.0 Records
Document No Description
Relevant Product Master formulae
Relevant Product Batch Manufacturing Protocols
MKB/PD/QF/005 Batch Record Sheet
MKB/PD/QF/001 Manufacturing Ticket
MKB/PD/QF/002 Packing Ticket
MKB/PD/QF/017 In-process Packing Control
MKB/PD/QF/003 Finished Goods Transfer Ticket
MKB/PD/QF/004 Rejection Ticket
MKB/QA/QC/QF/002 Non Conformance Report
MKB/PD/QF/011 Intimation to QA/QC for Test and analysis
MKB/PD/QF/006 Identification Slip

9.0 History
Revision No Description
00 Due to company name change

10.0 Distribution list

Copy No Issued to Location
01 D&RC Master record
02 Manager production Production Department

Note; In case of revision and circulation of new copy of the SOP, The obsolete copy will be returned to D&RC for
disposition.

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