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TABLE OF CONTENT

1. Protocol Cum-Report Pre-Approval

2. Introduction
3. Objective
4. Scope
5. Responsibility
6. Brief System Description
7. Reason for Requalification/Re-Validation
8. Frequency of Qualification
9. Training of Execution Team
10. Pre-Qualification & Validation Requirement
11. Validation Methodology
12. Acceptance Criteria
13. Machine Operation
14. Performance Test of Equipment
15. Test Equipment calibration
16. Vacuum Leak Rate Test
17. Bowie Dick Test
18. Heat Distribution Study
19. Heat Penetration Study
20. Biological Challenge Test (SAL)
21. References
22. Document to be attached
23. Change Control If any
24. Deviation from pre-defined parameters if any
25. Conclusion and summary
26. Abbreviations
27. Annexures
28. Execution Protocol cum report approval

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PROTOCOL CUM-REPORT PRE-APPROVAL

INITIATED BY:

DESIGNATION NAME SIGNATURE DATE

CHEMIST Q.A.

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

MANAGER (PRODUCTION)

MANAGER (ENGINEERING)

MANAGER (QUALITY
CONTROL)

APPROVED & AUTHORISED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD (QUALITY
ASSURANCE)

INTRODUCTION

• This document applies to the Moist Heat Sterilizer (Autoclave) Machine

Specified by XYZ Ltd.

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• The system is designed considering as the basis for specification parameters

with allowable parameters at the user end with suitable Design Limits.

OBJECTIVE

• The process of Autoclave is evaluated on basis of a Different Cycle Test design

to demonstrate that the sterilization and associated control procedure can
reproducibly deliver a sterile product.
• To confirm/demonstrate the efficiency of the sterilization process, which is
capable of killing the Micro-organisms & Pyrogene present in the article to
sterilize in the Moist Heat Sterilizer.
• To establish documented evidence that the Equipment is capable of
performing as per specified acceptance criteria and is adequate to provide the
assurance for which the process is intended.

• The performance shall be measured and evaluated by:

1. Vacuum leak Rate Test (3 trials)

2. Bowie Dick Test (3 Trials on different days)
3. Heat Distribution Study in different three cycles.
4. Heat Penetration Study
5. Biological challenge testing for standard and reduced cycle loads

• The Heat distribution & Heat penetration studies shall be conducted to check
the performance of the sterilization cycle.
• The validation protocol Cum-Report is designed to establish & provided
documentary evidence, to assure that the autoclave is suitable for Sterilizing
different load. In addition, this validation protocol Cum-Report is intended to
assure the sterility of the items, when the established Standard Operating
Procedure to maintain reliability and repeatability.
• To confirm the suitability of the Standard Operating Procedure for all routine
activities associated with the system.

SCOPE

• The Performance Qualification is an essential part of the qualification

mechanism. The scope of this protocol Cum-Report is to provide complete
documentary evidence for the performance qualification of the Autoclave.

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• The protocol Cum-Reports cover all aspects of Performance Qualification for

Autoclave Serving XYZ Ltd.,
• This protocol Cum-Report will define the method and documentation used to
quality the Autoclave for Performance Qualification.
• To ensure the Autoclave meets the cGMP requirement.
• To confirm the appropriateness of critical parameters of the Autoclave
components.
• To validate the system and check its performance.

RESPONSIBILITY

The Validation Group comprising of a representative from each of the following

Department shall be responsible for the overall compliance of this protocol Cum-
Report.

Quality Assurance:

• Preparation, Review, Approval, and Compilation of the Qualification Protocol

Cum-Report for Correctness, Completeness, and Technical Excellence.
• Protocol Cum-Report Training
• Coordination with Quality Control, Production, and Engineering to carry out
Qualification Activities.
• Monitoring of Qualification Activity.

Quality Control:

• Review of Qualification Protocol Cum-Report.

• Analytical Support (Microbiological Testing/Analysis)

Production:

• Review of Qualification Protocol Cum-Report.

• To coordinate and support Performance Qualification Activity.

Engineering:

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• Review of Qualification Protocol Cum-Report.

• To coordinate and support Performance Qualification Activity.
• Responsible for Troubleshooting during execution (If occurs)

BRIEF SYSTEM DESCRIPTION

• Performance Qualification shall be performed after completion and approval

of Operational Qualification.
• The equipment shall be used for Moist heat sterilization of pharmaceutical
requirements to be used in the formulation of the sterile area. The equipment
shall operate in a dust-free environment and conditions as per the GMP
requirements. The machine is designed to perform efficient Moist heat
sterilization in minimum time.
• Standard Moist heat Sterilizer is a Jacketed Vessel. In Moist Heat Sterilization
cycle is introduced into the jacket which ensures preheating of the chamber
and effective utilization of Moist heat energy.
• After fixed no. of pulses, Moist heat in the chamber is increased till the
sterilization temperatures are reached. The control system in place then
controls this chamber temperature for sterilization time.
• After the sterilization hold period is completed, temperature up to a pre-
determined level is created in the chamber. When this temperature level is
reached, the control system ensures that the temperature is maintained for
the specified time.

• The Moist Heat Sterilizer Process consists of the following phases:-

1. Heating phase to 121˚c

2. Pressure limit for sterilization NLT 1.5 kg
3. Sterilization temperature 121˚c
4. Sterilization time 30 min
5. Cooling time 15 min

Equipment Use

It is an industrial Moist heat sterilizer, specially designed for:

• Sterilization of machine parts, Membrane holder, rubber bungs, garments,

gloves, utensils, and assembly.

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REASON FOR QUALIFICATION / VALIDATION

• Periodic qualification/validation as per frequency mentioned in the Validation

master plan.
• Substitution of an existing system or its components with a new one.
• Any major modification in the existing system design & operational
parameters.
• If the system is found to be malfunctioning.
• Shifting of the system from one location to another.
• Periodic qualification / validation.
• If Installation of new Equipment.

(Specific Reason)
_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

FREQUENCY OF QUALIFICATION

• Yearly as per Master Validation Plan.

• After any major breakdown or modification.

TRAINING OF EXECUTION TEAM

• Training to the Execution Team shall be provided for execution of Protocol

Cum-Report before starting the Re-qualification/Re-validation activity.
• The Training shall be recorded in the training record.

PRE-QUALIFICATION & VALIDATION REQUIREMENTS

• To Conduct Re-qualification/Re-validation of Moist Heat Sterilizer, the

following requirements must be fulfilled:

1. Calibrated data logger with calibrated sensors.

2. Calibrated thermocouples.
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3. Qualified pure steam.

4. The integrity of vent filter at cooling zone
5. All parts of MHS used for measurement like temperature sensors, gauges,
timers must be calibrated.
6. All other instruments used for qualification must be calibrated.

VALIDATION METHODOLOGY

• The Moist Heat Sterilizer shall be considered Qualification / Validation

successful completion on the following test:

1. Empty Chamber Heat Distribution Studies (1 cycle) with Temperature sensor

at different locations of the Sterilizer Chamber.
2. Loaded chamber Heat Distribution Studies (1cycles) for each sterilization load
of a possible layer of the load subjected for sterilization.
3. Half Loaded chamber Heat Distribution Studies (1cycles) for each sterilization
load of a possible layer of the load subjected for sterilization.
4. After Successfully of Heat Distribution study, shall perform Bio-challenge
studies using Geobacillus stearothermophilus spore Ampoule (containing 106
more spores) during the heat penetration studies in different three cycles as
empty chamber, half load, and full load.
5. Estimation of the F0 value achieves during the sterilization hold period at each
temperature mapping probe.
6. To quality these tests, the Equipment should fulfill the acceptance criteria
described in the individual test procedure.
7. To quality these tests, the Equipment should fulfill the acceptance criteria
described in the individual test procedure.

ACCEPTANCE CRITERIA

• Performance qualification shall be considered acceptable when requirements

of this protocol Cum - Report have been fulfilled and all the components of the
Moist Heat Sterilizer performed as per the design specifications and as per
manufacturer recommendations.

MACHINE OPERATION

The machine operation consists of the following operations:

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• Load the chamber and close the door.

• Upcoming temperature for sterilization 121˚c at the pressure between 15-18
lbs or NLT 1.5 kg/cm2.
• Hold the sterilization temperature for a minimum of 15 min to a maximum of
30 min sterilization time.
• After completion of sterilization process put on hold for 15 min as a cooling
phase.
• Unload the lot in a sterile buffer zone under LAF.

PERFORMANCE TEST OF EQUIPMENT

1. The performance qualification test should be performed for different

parameters of Moist Heat Sterilizer.
2. All tests and those classifications are given below:

• Test Equipment Calibration

• Vacuum Test (3 trials)
• Bowie Dick Test (3 Trials on different days)
• Heat Distribution Study in different three-cycle

- Heat Distribution Study In Empty Chamber

- Heat Distribution Study in Full Load.

- Heat Distribution Study In Half Load

• Heat Penetration Study with Bio-challenge test in different three-cycle.

- Heat Penetration Study in Empty Chamber with biological Indicators

-Heat Penetration Study in Full Load with biological Indicators with Ampoules/Vials.

-Heat Penetration Study in Half Load with biological Indicators with Ampoules/Vials.

• Biological challenge testing for standard and reduced cycle loads

Test Equipment Calibration

• Review the calibration status for the test equipment (Data-Logger with
sensors) to be utilized and record the calibration due. All Equipment /
Instrumentation must remain within the calibration due date for the duration
of the Revalidation Study for which the item is used. If a due date potential
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occurs during the testing period then the instrument must be re-calibrated
before it is utilized. Record the calibration details.

PRE & POST CALIBRATION OF TEMPERATURE MEASURING SENSOR:

Pre & post-calibration shall be carried out before starting and after completion of the
Heat Distribution cycle as well as the Heat Penetration cycle.

Preparation of Ice Bath

• Prepare a container with crushed ice and add enough purified water to ensure
a proper slush solution.
• Allow the temperature to stabilize; ensure to add sufficient crushed Ice to
maintain the equilibrium state of Ice and water.

Procedure

• Temperature sensors that are to be used for the qualification study shall be
calibrated in Ice Bath at approximately 0ºC and in High-Temperature reference
data logger block at 50,100,121 & 150ºC prior to its usage in the qualification.
• Record the temperature of all the sensors while putting them in Ice Bath after
1 minute of temperature stabilization.
• Put individual sensor to the slot of High-temperature Reference block which is
stabilized at the required temperature Record the reading at least one minute
after stabilization of temperature.
• Record the temperature for five minutes by the data logger and record the
temperature from data logger display

Acceptance Criteria

• No temperature sensor should vary by 1ºC in Ice Bath from the means of
temperature shown by the calibrated thermometer during the Data-logging
period.
• No temperature sensor should vary by 1ºC in High-temperature reference
block from the mean of temperature shown by calibrated thermometer during
the data-logging period.

Results
Record the calibration details in.

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Vaccum Leak Test Rate

Objective

• To verify integrity of the chamber and door seals via pressure hold test under
vacuum .

Procedure

• Shut the door of autoclave properly.

• Apply the 100 m bar or 0.93 kg /cm2 pressure and record the P1, P2, P3.
• P1 (achieved desired vacuum),
• P2 (at hold 5 min or after 5 min.
• P3 (after 10min of P2).
• Calculate the vacuum drop / min by use following formula.

(P3 –P2) / 10
Acceptance criteria

• The rate of vacuum drop at the end of 10 min not more than 30 m bar or 1.3
m bar /min.
•

Bowie Dick Test

Objective

• The bowie dick test the demonstrates proper air removal from the chamber
of a pre vacuum autoclave.

Procedure

• To run the test, a pack is placed in an empty chamber on the lowest shelf above
the drain (the coldest point in the chamber) and a bowie dick cycle is
initiated the sterilization cycle consist of three to four prevacuum pulses
reaching the set point of Temperature 121˚c.
• The termochromatic paper put inside the pack will indicate if steam has
penetrated the porous load. A bowie dick test pack that shows a uniform dark
black color pattern indicates a successful vacuum and full steam penetration,
where as no or partial color change indicates an unsuccessful test cycle.

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Acceptance criteria

• Bowie dick test pack should be uniform dark black color pattern indicates.

Heat Distribution Study

A. Heat Distribution Study in Empty Chamber

Objective

• Physical qualification of the production sterilization cycle to demonstrate that

heat distribution with in the empty chamber is consistent.
• The Sterilizer is capable of at training a temperature and pressure of 121ºC
and 1.5 kg/cm2 or 15 lbs during the sterilization hold period.

Procedure

• Fit the 16 thermocouple probes (S1, S2, S3…….S16) through the validation port
in the autoclave door and check the connection to the autoclave data recorder
the position each probe. Probe replacement inside the chamber shall reflect
the result for determination of hot and cold point with in chamber.

Acceptance criteria

• Record over all time for cycle and verify that heating time is consistent.
• Leak rate test remain within specification.

1. Stratification within is the a chamber is acceptable. that is thermocouple

probes mesure within ±2˚C of each other.
2. All measured thermocouple temperature show 121˚C +3/-0˚C and do not
fluctuate by more than 1˚C During the sterilization hold phase.
3. At least 10 thermocouples probes remain active during the study.
4. Correlate autoclave temperature and pressure readings during the
sterilization hold time, against saturated steam tables and record the result.
5. Verify that the accumulated heat loads for each probe as indicated by F0 are
consistant.

FPhys = ΔtΣ10 (T0 -Tref) / Z

Where

Δt = 1 minute

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T0 = Thermocouple temperature (˚C)

Tref = 121˚C

Z = Value specific to biological indicator used or 10˚C if not specified.

B. Heat Distribution Study in Loaded Chamber

• Physical qualification of the production sterilization cycle to demonstrate that

heat distribution within the loaded chamber is consistent.
• The Sterilizer is capable of at training a temperature and pressure of 121ºC
and 1.5 kg/cm2 or 15 lbs during the sterilization hold period.

Procedure

• Define the Load pattern as Loaded cycles

• Load cycles 1 : 15 pairs of Sterile dress, 30 pairs of gloves.
• Load cycle 2 : Machine parts, one filling vessel, one filter assembly.
• Load cycle 3 : Maximum 50000 rubber plugs / 50000 flip off seals.
• Fit the 16 thermocouple probes ( S1, S2, S3…….S16) through the validation port
in the autoclave door and check the connection to the autoclave data recorder
the position each probe.probe replacement inside the chamber shall reflect
the result for determination of hot and cold point with in chamber.

Acceptance criteria

• Record over all time for cycle and verify that heating time is consistent.
• Leak rate test remain within specification.

1. Stratification within is the a chamber is acceptable that is thermocouple

probes mesure within ± 2˚C of each other.
2. All measured thermocouple temperature show 121˚C +3/-0˚C and do not
fluctuate by more than 1˚C During the sterilization hold phase.
3. At least 10 thermocouples probes remain active during the study.
4. Correlate autoclave temperature and pressure readings during the
sterilization hold time, against saturated steam tables and record the result.
5. Verify that the accumulated heat loads for each probe as indicated by F0 are
consistant.

FPhys = ΔtΣ10 (T0 -Tref) / Z

Where
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Δt = 1 minute

T0 = Thermocouple temperature (˚C)

Tref = 121˚C

Z = Value specific to biological indicator used or 10˚C if not specified.

• Verify that the “cold-spot” location is constant, in three consecutive cycles, for
defined load pattern .

Heat Penetration Study

Objective

• Physical qualification of the sterilization cycle to demonstrate that heat

penetration equipment load items effectively for the standard load
configuration set out in this protocol.
• To ensure that if sterilization temperature (121ºC) is not achieved throughout
the cycle, load configuration or size of the load has to be reviewed and
sterilization cycle to be repeated.
• Heat Penetration Studies shall be carried out with the following the different
load.

1. Load cycle 1
2. Load cycle 2
3. Load cycle 3

Procedure

• Open the door and put the defined load and thermocouples probe and run
the cycle for standard time after shutting the doo properly.
• Fit the 16 thermocouple probes (S1, S2, S3…….S16) through the validation port
in the autoclave door and check the connection to the autoclave data recorder
the position each probe.probe replacement inside the chamber shall reflect
the result for determination of hot and cold point with in chamber.

Acceptance criteria

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• Verify the consistency of operation of sterilization production cycle

parameters – Heating phase 121ºC
• Sterilization temperature 121ºC Sterilization time 15 Min
• Vacuum Leak Rate test remain within specification.
• Stratification within is the a chamber is acceptable. that is thermocouple
probes mesure within ±2˚C of each other.
• All measured thermocouple temperature show 121˚C +3/-0˚C and do not
fluctuate by more than 1˚C During the sterilization hold phase.
• At least 10 thermocouples probes remain active during the study.
• Correlate autoclave temperature and pressure readings during the
sterilization hold time, against saturated steam tables and record the result.
• Verify that the accumulated heat loads for each probe as indicated by F0 are
consistant.

FPhys = ΔtΣ10 (T0 -Tref) / Z

Where

Δt = 1 minute

T0 = Thermocouple temperature (˚C)

Tref = 121˚C

Z = Value specific to biological indicator used or 10˚C if not specified.

• Verify that the “cold-spot” location is constant, in three consecutive cycles, for
defined load pattern .

Biological Challenge Test for Loaded Cycle

Objective

• Biological qualification of the sterilization cycle to demonstrate that the

delivered lethality measured by the actual kill of micro-organism on a
biological indicator system results in PNSU ≤ 10-6.
• PNSU : Probability of a non-sterile unit .
• SAL : Sterility Assurance Level

Guidelines for handling Biological Indicators

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• Collect the required number of GPT (Growth Promotion Test ) passed

Biological indicators from the Microbiological Laboratory. Transfer the
ampoules in a sealed bag to the facility.
• Handle the glass ampoules carefully. Keep spare gloves and sample jar close
by case of damage. If an ampoule is damaged, than transfer immediately to
the sample jar and seal. Change the gloves, and notify production, so that the
area can be cleaned down accordingly, using a sporicidal sanitant (10%
H2O2 in 70 % solution and leave to soak for 60 minutes. Contaminated gloves,
and samples shall be transferred to the microbiology Laboratory for disposal.
• Treat all autoclaved biological indicators as potentially viable an handle as
described about places in a sealed bag for transfer back to the microbiology
lab.
• Verify that the number if biological indicators issued and the no. returned from
to the microbiology laboratory are the same (100% accountability ) inform the
production manager on duty immediately of any discrepancies.

Procedure

• This test is run concurrently with the test of heat penetration (i.e. temperature
probes and biological indicators placed adjacently in the same loads).
• Record the position and tag of each biological indicators Complete the
sterilization cycle as heat penetration study.
• Stop the heat penetration study after the first sterilization cycle has
completed.
• Open the door prepare and prepare the next test cycle removing by the used
biological indicators and placing a fresh biological indicators adjacent to each
temperature probes.
• Transfer the used BIs to the microbiology lab for incubation and testing
• Calculate the actual log reduction (Nf =actual PNSU) of micro-organisms using:

FBIO = D121(Log N0 –Log NF)

Where

FBIO = Fphys (as found from heat penetration study)

D121 and N0 (From BI data)

Acceptance criteria

• There shall be no growth of BIs, which have undergone the sterilization cycle.

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• There shall be positive growth of the controlled biological indicators, which

have not undergone the sterilization cycle.
• Bio-indictors shall comply with specification before use. Glass ampoules
G.stearothermophilus the biological indicators shall have:
• Population > 5 x 105 G.stearothermophilus per ampoules, With a D value of
not less than 1.5 min and not more than 2 min.

REFERENCES

The Principle Reference is the following:

1. Master Validation Plan

2. Schedule –M-“Good Manufacturing Practices” and Requirement of Premises,
Plant and Equipment for Pharmaceutical Product.
3. WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol.-2
Good Manufacturing Practices and Inspection.
4. The following references are used to give addition guidance:
5. Code of federal regulation (CFR), title 21, Part 210 current-Good Manufacturing
Practices (cGMP) in Manufacturing, Processing, Packing of Holding of Drugs,
General.April1,1998.
6. Code of federal regulation (CFR), title 21, Part 211 current-Good Manufacturing
Practices (cGMP) for Finished Pharmaceuticals April1,1998.
7. EU Guide to Good Manufacturing Practices, Part 4, 1997.

DOCUMENT TO BE ATTACHED

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

CHANGE CONTROL, IF ANY:

_______________________________________________________________________________________
_______________________________________________________________________________________

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_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

DEVIATIONS FROM PRE-DEFINED PARAMETER (IF ANY):

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

CONCLUSION AND SUMMARY

Based on the validation results and reports, conclusion shall be drawn on the overall
Performance of the Moist Heat sterilizer. The summary Protocol Cum-Report shall be
reviewed and approved by Quality Assurance Team.

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

_______________________________________________________________________________________
_______________________________________________________________________________________

Verified By: Reviewed By:

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ABBREVIATIONS

CFM : Cubic Feet Meter

Pvt. : Private

Ltd. : Limited

D.M. : Demineralized

Maint. : Maintenance

QA : Quality Assurance

No. : Number

◦C : Degree Celsius

GMP : Good Manufacturing Practices

WHO : World Health Organization

CFR : Code of Federal Regulation

BIs : Biological indicaors

PNSU : Probability of a non – sterile unit

SAL : Sterility Assurance Level

ANNEXURES

Annexure-01: Training record

Annexure-02: Calibration detail

Annexure-03: Vacuum Leak rate Test

Annexure-04: Bowie Dick Test

Annexure-05: Heat distribution study

Annexure-06: Heat penetration study

Annexure-07: Biological challenge Test ( Sterility Assurance Level)

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EXECUTED PROTOCOL CUM-REPORT APPROVAL

The below-listed review and approval signatures indicate approval of this protocol
Cum-Report and its attachments and certify that it may be executed.

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

MANAGER
(PRODUCTION)

MANAGER
(ENGINEERING)

MANAGER
(QUALITY CONTROL)

APPROVED & AUTHORISED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD (QUALITY
ASSURANCE)

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