PERFORMANCE QUALIFICATION REPORT PROTOCOL No.

:
FOR REPORT No.:
BLISTER PACKING MACHINE
PHARMA
Page No.: 1 of 14
SCHOLARS

PERFORMANCE QUALIFICATION
REPORT
FOR
BLISTER PACKING MACHINE
(…………….BLOCK)
EQUIPMENT ID: ………………..

DATE OF REQUALIFICATION
SUPERSEDES REPORT NO.

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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BLISTER PACKING MACHINE
PHARMA
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PROTOCOL CONTENT

S.No. TITLE PAGE No.

1.0 REPORT PRE-APPROVAL 3

2.0 OBJECTIVE 4
3.0 SCOPE 4
4.0 RESPONSIBILITY 5
5.0 EQUIPMENT DETAILS 6
6.0 PRE-QUALIFICATION REQUIREMENTS 6-7
7.0 EXHIBITS 8-10
8.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY 11
9.0 CHANGE CONTROL, IF ANY 11
10.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ) 11
11.0 CONCLUSION 11
12.0 RECOMMENDATION 11

13.0 DOCUMENTS TO BE ATTACHED 11

14.0 EXECUTED REPORT APPROVAL 12
15.0 ABBREVIATIONS 13

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 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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1.0 REPORT PRE -APPROVAL:

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)

AUTHORIZED BY:
DESIGNATION NAME SIGNATURE DATE
VICE PRESIDENT
(QUALITY ASSURANCE)

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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2.0 OBJECTIVE:

• To establish documented evidences that the Equipment is performing as per the

predetermined operational parameters and that it gives results within the
predetermined acceptance criteria.
• To demonstrate that the system is operating reproducibly and consistently within its
operating range.
• To confirm the suitability of the established Standard Operating Procedures for all
routine activities associated with the equipment.

3.0 SCOPE:

• The Protocol covers all aspects of Performance Qualification for the Blister Packing
Machine serving Packing area at ……………………………..
• This Protocol will define the methods and documentation to be used for qualification
of the Blister Packing Machine.

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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BLISTER PACKING MACHINE
PHARMA
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4.0 RESPONSIBILITY:
The Validation Team, comprising of a representative from each of the following Departments,
shall be responsible for the overall compliance of this Protocol:

DEPARTMENTS RESPONSIBILITIES

• Preparation, Review, Approval and Compilation of the Performance

qualification Protocol cum Report.
Quality Assurance • Co-ordination with Quality Control, Production and Engineering
Departments to carryout Performance qualification Activities.
• Monitoring of Performance qualification Activities.

• Review of Protocol cum Report before and after execution.

Production • To co-ordinate and support to other departments for conducting
Performance qualification Activity.
• Review of Performance qualification protocol for correctness,
completeness and technical excellence.
Engineering
• Review of protocol cum report after execution.
• Trouble shooting for problems (if occurred during execution).

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PHARMA
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5.0 EQUIPMENT DETAILS:

Equipment Name BLISTER PACKING MACHINE

Manufacturer’s Name

Location of Installation Packing Area

Equipment ID No.

6.0 PRE-QUALIFICATION REQUIREMENTS:

The results of any tests should meet the limits and acceptance criteria specified in the test documents.
Any deviations or issues should be rectified and documented prior to PQ commencing. Following
instrument should be verified before Performance Qualification.

• Calibrated Tachometer
• Calibrated Leak test apparatus
• Calibrated Thermometer & sensor
• Semi Finished Product

6.1 SYSTEM PRE-REQUISITES:

Verify that the DQ/IQ/OQ of the Blister machine has been executed and approved.
Verify that the Operating and Cleaning SOP of the blister packing machine has been prepared.
CHECKED BY VERIFIED BY
DOCUMENT/ COMPLETED
S.No. DOCUMENT NAME (PRODUCTION) (QA)
SOP No. (YES / NO)
(SIGN/DATE) (SIGN/DATE)
1. DQ Protocol

2. IQ Protocol

3. OQ Protocol

4. Operating Procedure
SOP
5. Cleaning Procedure
SOP

FORMAT No.: ……………………….

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PHARMA
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6.2 PROPOSED PRODUCT BATCH INFORMATION:

S.No. Product Name Batch no. Batch size Mfg date Expiry date

6.3 VERIFICATION OF RPM AT EMPTY CONDITION:

S.No. Instrument Batch no. Calibration Calibration Calibration Set Observed
status Done on Due on RPM RPM

6.4 TEST INSTRUMENT CALIBRATION:

• Verify that all instruments/equipments required for the verification of the critical operational
parameters are in calibrated state.
• Review the calibration status for the test equipments/instruments to be utilised during
operational qualification activities and record the calibration status.

Equipment/ Equipment/ Calibration Done Calibration Due Observed By

Instrument Name Instrument ID On On (QA)
(Sign & Date)

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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7.0 EXHIBITS:
7.1 Exhibit-1:

Date: Time:
Product Name:
Batch No.: Batch Size:
Description:

Average Weight of Tablet (mg):

Size of Capsule (000 to 5):
Size of Soft Gelatin Capsule (minim):
Pack Size:

Checks for Operational Speed of Machine Speed of Forming Sealing

Parameters (rpm) Machine Temp. Temp.
(cuts/min.)

Checks for Packing Leak Test Cutting Edges Empty Imprint

Parameters Blister
(10 Blister Packs
should be inspected)
Perforation of Blister Overheating Damaged Units of Product

Compiled By: ……………

(QA) Sign & Date

Inference:…………………………………………………………………………………………………………
……….……………………………………………………………………………………………………………
……………………………………………………………….……………………………………………..……..
Reviewed By:……………….
(Manager QA)
Sign/Date

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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7.2 Exhibit-2:

Date: Time:
Product Name:
Batch No.: Batch Size:
Description:

Average Weight of Tablet (mg):

Size of Capsule (000 to 5):
Size of Soft Gelatin Capsule (minim):
Pack Size:

Checks for Operational Speed of Machine Speed of Forming Sealing

Parameters (rpm) Machine Temp. Temp.
(cuts/min.)

Checks for Packing Leak Test Cutting Edges Empty Imprint

Parameters Blister
(10 Blister Packs
should be inspected)
Perforation of Blister Overheating Damaged Units of Product

Compiled By: ……………

(QA) Sign & Date

Inference:…………………………………………………………………………………………………………
……….……………………………………………………………………………………………………………
……………………………………………………………….…………………..………………………………..

Reviewed By:……………….
(Manager QA)
Sign/Date

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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BLISTER PACKING MACHINE
PHARMA
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7.3 Exhibit-3:

Date: Time:
Product Name:
Batch No.: Batch Size:
Description:

Average Weight of Tablet (mg):

Size of Capsule (000 to 5):
Size of Soft Gelatin Capsule (minim):
Pack Size:

Checks for Operational Speed of Machine Speed of Forming Sealing

Parameters (rpm) Machine Temp. Temp.
(cuts/min.)

Checks for Packing Leak Test Cutting Edges Empty Imprint

Parameters Blister
(10 Blister Packs
should be inspected)
Perforation of Blister Overheating Damaged Units of Product

Compiled By: ……………

(QA)
Sign & Date

Inference:…………………………………………………………………………………………………………
……….……………………………………………………………………………………………………………
……………………………………………………………….………………..…………………………………..

Reviewed By:……………….
(Manager QA)
Sign/Date

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
FOR REPORT No.:
BLISTER PACKING MACHINE
PHARMA
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8.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, (IF ANY):

…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
………………………………………………………………………………………………………

9.0 CHANGE CONTROL, (IF ANY):

…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
………………………………………………………………………………………………………

10.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) :

…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
………………………………………………………………………………………………………

11.0 CONCLUSION:

…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
………………………………………………………………………………………………………

12.0 RECOMMENDATION:

…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
………………………………………………………………………………………………………

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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13.0 DOCUMENTS TO BE ATTACHED:

• Operation And Maintenance Manual

• Final SOPs
• Calibration certificates
• Any Other Relevant Documents

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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BLISTER PACKING MACHINE
PHARMA
Page No.: 13 of 14
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14.0 EXECUTED PROTOCOL -APPROVAL

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(PRODUCTION)
HEAD
(QUALITY CONTROL)
HEAD
(ENGINEERING)

APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)

AUTHORIZED BY:
DESIGNATION NAME SIGNATURE DATE
VICE PRESIDENT
(QUALITY ASSURANCE)

FORMAT No.: ……………………….

 PERFORMANCE QUALIFICATION REPORT PROTOCOL No.:
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PHARMA
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15.0 ABBREVIATION:
Sr. : Senior
Asst. : Assistant
No. : Number
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
cGMP : current Good Manufacturing Practices
EU : European Union
QA : Quality Assurance
IQ : Installation Qualification
mm : Millimeter
Amp. : Ampere
RPM : Revolutions Per Minute
Min : Minute
mg : Milligram
min. : Minimum
Max. : Maximum
Wt. : Weight
Avg. : Average

FORMAT No.: ……………………….