Transportation TIPA - For Present - 28 Aug 2021 - For Private

YAOWAPHA KAEWSAITA
Pilot scale section

The Government Pharmaceutical Organization
28 August 2021
1
CONTENT
COMPLYING TRANSPORTATION REQUIREMENTS
1 REFERENCES
2 PRINCIPLES
3 GROUPING
4 PARAMETER
5 RISK ASSESSMENT
6 PROTOCOL TEMPLATE
7 EXAMPLE
8 ANALYSIS OF DATA
9 MONITOR AND RE-VALIDATION
2
REFERENCE
COMPLYING TRANSPORTATION REQUIREMENTS
GMP: 2564
ประกาศกระทรวงสาธารณสุข เรื่อง หลักเกณฑ์ วิธีการ และเงือ่ นไขในการกระจายยาแผน
ปั จจุบัน พ.ศ. 2564 ตามราชกิจจานุเบกษา ๒๑ พฤษภาคม ๒๕๖๔: หมวดที่ ๙ การขนส่ง
 ประกาศนีใ้ ห้ใช้บงั คับตัง้ แต่วันที่ 1 มกราคม 2565 เป็ นต้นไป
PIC/S: 1 June 2014
PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL
PRODUCTS (PE 011-1) 1 June 2014 :CHAPTER 9 TRANSPORTATION
EU: 5 November 2013
Good Distribution Practice of Medicinal Products for Human use (Text
with EEA relevance) (2013/C 343/01): CHAPTER 9 — TRANSPORTATION
WHO Technical Report Series, No.957, 2010
Annex5: WHO good distribution practices for pharmaceutical products

Annex9: Model guidance for the storage and transport of time- and temperature–
sensitive pharmaceutical products (Supplement 8,10,12,14,15)
3
PRINCIPLES
COMPLYING TRANSPORTATION
VERIFICATION REQUIREMENTS
OF TRANSPORTATION
4
PRINCIPLES
OF TRANSPORTATION
กองยา
สานักงานคณะกรรมการอาหารและยา
1 ตุลาคม 2563
5
PRINCIPLES
OF TRANSPORTATION
การตรวจสอบยืนยันการขนส่ง
(verification of transportation)
6
PRINCIPLES
OF TRANSPORTATION
9.2.1 ต้องควบคุมสภาวะการจัดเก็บผลิตภัณฑ์
ระหว่างการขนส่งให้เหมาะสม ตามทีร่ ะบุบนฉลาก
9.2.3 ต้องทาให้ม่ันใจว่า ยานพาหนะและอุปกรณ์ทใี่ ช้
ในการแจกจ่าย จัดเก็บหรือ จัดการผลิตภัณฑ์ยา มี
ความเหมาะสมกับการใช้งานและได้รับการติดตัง้ อย่าง
เหมาะสม
9.2.4 ต้องมีวธิ ีการปฏิบัตงิ านเป็ นรายลักษณ์อักษร ใน
การใช้งานและบารุ งรักษาพาหนะและอุปกรณ์
9.2.5 ต้องมีการประมินความเสี่ยงของเส้นทางการ
ขนส่ง
9.2.6 กรณีทไี่ ม่สามารถจัดหารถและอุปกรณ์ได้ ก็ต้อง
มีวธิ ีการทาให้เกิดความมั่นใจว่าผลิตภัณฑ์จะไม่ได้รับ
ผลกระทบ
9.2.6 ผลิตภัณฑ์ยาต้องถูกจัดส่งไปยังทีอ่ ยู่ทรี่ ะบุในใบ
ส่งสินค้าเท่านั้น
(verification of transportation)
7
REFERENCE
VERIFICATION OF TRANSPORTATION
GMP: 2016
การกาหนดรายละเอียดเกี่ยวกับหลักเกณฑ์และวิธีการในการผลิตยาแผนปัจจุบัน และแก้ไขเพิ่มเติม
หลักเกณฑ์และวิธีการวงในการผลิตยาแผนโบราณ ตามกฎหมายว่าด้วยยา พ.ศ. ๒๕๕๙ ภาคผนวก
๑๔ การตรวจรับรองและการตรวจสอบความถูกต้อง
PIC/S : 1 May 2021
Annex 15 Qualification and validation PE 009-15 (Annexes) 1 May 2021
EU: 30 March 2015

Guidelines for Good Manufacturing Practice
for Medicinal Products for Human and Veterinary Use:
Annex 15: Qualification and Validation, Ref. Ares(2015)1380025 - 30/03/2015

Annex9: Model guidance for the storage and transport of time- and temperature–sensitive
pharmaceutical products (Supplement 8,10,12,14,15)
8
PRINCIPLES
9
PRINCIPLES
• ผลิตภัณฑ์ยาสาเร็จรูป ผลิตภัณฑ์ยาวิจัย ผลิตภัณฑ์ยารอการบรรจุ และตัวอย่าง ต้องจัดส่งจากสถานที่ผลิต
ตามสภาวะที่กาหนดในทะเบียนตารับยา บนฉลากที่อนุมัติแล้ว แฟ้มข้อกาหนดผลิตภัณฑ์ หรือตามที่ผู้ผลิต
ข้อที่ ๖๗
กาหนด
• การตรวจสอบยืนยันการขนส่งเป็นสิ่งที่ท้าทาย เนื่องจากมีหลายปัจจัยเกี่ยวข้อง แต่เส้นทางการขนส่งต้อง
กาหนดให้ชัดเจน ต้องนาความแปรปรวนทางฤดูกาล และความแปรปรวนอืน่ นมาพิจารณาในการตรวจสอบ
ข้อที่ ๖๘ ยืนยันการขนส่งด้วย
• ต้องทาการประเมินความเสี่ยงเพื่อพิจารณาผลกระทบจากความแปรปรวนในกระบวนการขนส่งทีน่ อกเหนือจาก
สภาวะที่ควบคุม หรือเฝ้าติดตามอย่างต่อเนื่อง เช่น ความล่าช้าระหว่างการขนส่ง อุปกรณ์เฝ้าติดตามล้มเหลว
ข้อที่ ๖๙ ไนโตรเจนเหลวล้น ความเปราะบางของผลิตภัณฑ์ และปัจจัยอื่นที่เกี่ยวข้อง
• เนื่องจากสภาวะความแปรปรวนระหว่างการขนส่ง จึงต้องเฝ้าระวัง และบันทึกสภาพแวดล้อมวิกฤตที่อาจส่งผล

ต่อผลิตภัณฑ์อย่างต่อเนื่อง เว้นแต่จะมีเหตุผลอื่น
ข้อที่ ๗๐
10
PRINCIPLES
การตรวจสอบยืนยันการขนส่ง VERIFICATION OF TRANSPORTATION
67. ผลิตภัณฑ์สาเร็จรูป • สภาวะการจัดเก็บยา (storage condition of product)

(Products) • พาหนะการจัดส่ง (Vehicle)
• เส้นทางการขนส่ง
68. ปัจจัยที่เกี่ยวข้อง
• ความแปรปรวนตามฤดูกาล
(Parameter)
• ความแปรปรวนอื่นๆ
• ความล่าช้าระหว่างการขนส่ง
69. ประเมินความเสี่ยง (Risk
• อุปกรณ์เฝ้าติดตามล้มเหลว
assessment) • ความเปราะบางของผลิตภัณฑ์
• Protocol, Execute, Report
การตรวจสอบยืนยัน
• Consecutive 7days
70. บันทึกต่อเนื่อง • Monitor

(Monitor) • Periodic or revalidate
Ref: การกาหนดรายละเอียดเกี่ยวกับหลักเกณฑ์และวิธีการในการผลิตยาแผนปัจจุบัน และแก้ไขเพิ่มเติมหลักเกณฑ์และวิธีการในการผลิต

11 ยาแผนโบราณ ตามกฎหมายว่าด้วยยา พ.ศ. ๒๕๕๙ ภาคผนวก ๑๔ การตรวจรับรองและการตรวจสอบความถูกต้อง
PRINCIPLES
12
PRINCIPLES
Objective of Verification of transportation

To ensure that Time and
temperature-sensitive
pharmaceutical product
Protection of Time and (TTSPPs ) can be safely
temperature-sensitive transported within the
pharmaceutical product transport temperature
(TTSPPs ) against profile defined for each
degradation. product and that compliance
can be demonstrated to the
regulatory authorities and
other interested parties.
Ref: WHO Technical Report Series, No.961, 2011: Annex 9 Model guidance for the storage and transport
of time- and temperature–sensitive pharmaceutical products
13
PRINCIPLES
• Provide air temperature monitoring systems and devices

for vehicles used to transport TTSPPs.
• Monitoring sensors accurate to ± 0.5 °C.
Temperature • monitoring sensors calibrated least once a year.
monitoring in
temperature- • monitoring sensors located to monitor worst-case
controlled temperatures within the qualified storage zone.
road vehicles • provide a temperature record with a minimum recording
frequency of six times per hour for each sensor position
• Provide documentation which can be stored and
accessed
Ref: WHO Technical Report Series, No.961, 2011: Annex 9 Model guidance for the storage and transport of time- and
temperature–sensitive pharmaceutical products
14
EQUIPMEMT
ASSOCIATED MATERIAL AND EQUIPMENT

 Sufficient number of
electronic data logging
monitors
 Specification CALIBRATED ACCURATE
Requirements
 Ease of use and
integration across the RELIABLE STABLE
supply chain
 Suitable computer
equipment and software
Ref: Supplement 15; Temperature and humidity monitoring systems for transport operations, Technical supplement to WHO
Technical Report Series, No.961, 2011: Annex9, August 2014
15
EQUIPMEMT
Device types: Electronic Data Integrators (EDI).

Berlinger Q-Tag® CLm Doc
Ref: Supplement 15; Temperature and humidity monitoring systems for transport operations, Technical supplement to WHO Technical Report Series, No.961,
2011: Annex9, August 2014
16
GROUPING
 Storage condition each of

products
 The protocol should define the

required acceptance criteria
based on the type of
pharmaceutical product
being stored, clearly stating
the temperature limits that are
allowable within the area to be
mapped.
 Vehicles
17
GROUPING
 Transportation Vehicles Database

 Objective
 Scope
 Equipment data base
 Conclusion
18
PARAMETER
 Transportation routes should be clearly defined
 Seasonal
 Temperature in Finished product transportation vehicle shall be done
for 3 subsequent seasons namely summer, rainy and winter.
 The probable period for various season are as follows;
o Summer: February to May
o Rainy: June to September
o Winter: October to January
The season shall be considered as the above period or the yearly seasonal
forecast by Thai Meteorological Department, Ministry of Digital Economy and
Society.
Ref: The Seasonal forecast of Thailand during the Rainy Season of 2017, issued on 25 April 2017; The rainy season of Thailand
this year is expected to start as normal around middle May and will end at about middle October.
19
RISK ASSESSMENT
 Different techniques: FMEA
 Classified : High, medium, low

-- Probability
oDelays during transportation
oFailure of monitoring devices
oProduct susceptibility
-- Severity
oRisk for the patient
oBusiness continuity
-- Detection
oEase of detection
20
PROTOCOL TEMPLATE
 The mapping protocol should contain the following sections:

a. Approval page and change control history
b. Acronyms and glossary
c. Description and rationale
d. Scope
e. Objectives
f. Responsibility
g. Methodology
h. Report template
i. Annexes as needed, including templates for the mapping report.
21
PROTOCOL TEMPLATE
a. Approval page and change control history
22
PROTOCOL TEMPLATE
b. Acronyms and glossary
 Define the acronyms and technical terms used in the protocol.
23
PROTOCOL TEMPLATE
c. Description and rationale
 Describe the installation to be mapped and outline

the reasons for carrying out the exercise.
24
PROTOCOL TEMPLATE
d. Scope
 Clearly define the scope and purpose of the transportation

study. evaluate uniform temperature distribution of the
finished product transport vehicle as per its predetermined
specification
 Describe the transportation route
25
PROTOCOL TEMPLATE
e. Objectives
 The detailed objectives of the study transportation

vehicle should be clearly defined
Example:
to provide the outline for inspection of the transportation
vehicle to verify that the performance of the transportation
vehicle is complying with the predetermined specifications
26
PROTOCOL TEMPLATE
f. Responsibility
 The validation team requires the involvement and close

interaction of Quality Assurance Department and
Warehouse division in consultation with other
appropriate supporting groups
Example:
-QA Manager
-Quality Assurance Representative
-Warehouse Representative
27
PROTOCOL TEMPLATE
g. Methodology
The following Technical Supplements are also relevant:
Checking the Temperature and

Qualification of Qualification of
accuracy of humidity monitoring
temperature- temperature-
temperature control systems for
controlled road controlled storage
and monitoring transport
vehicles areas
devices operations.
28
PROTOCOL TEMPLATE
g. Methodology
The mapping of temperature in the finished product transportation

vehicle shall be done and analyzed by observing the following
parameters.
Distribution of
temperature in
vehicle container. Temperature to be
maintained with in
specified limit.
29
PROTOCOL TEMPLATE
g. Methodology
Step 1- Select data loggers:
• Have a time recording intervals to be set in the range

from 1 minute to 10 minute
(minimum recording frequency of 6 times per hour)
• Enable the recorded time-temperature data to be
downloaded to a computer system for subsequent
analysis
• software that complies with regulatory requirements (for
example: 21 CFR part 11)
30
PROTOCOL TEMPLATE
g. Methodology
• All data loggers must have a US National Institute of

Standards and Technology (NIST)-traceable 3-point calibration
completed, valid and have an error no more than ± 0.5 °C at
each calibration point.
• Humidity sensors accurate to ± 5% RH(If required)
• Sufficient memory for the intended duration of the study.
• Calibrate devices against a certified, traceable reference
standard at least once a year,
31
PROTOCOL TEMPLATE
g. Methodology
Berlinger Q-Tag® CLm Doc
Performance Quality Safety

Equipment Brand-Model
(PQS code) by WHO
Data logger Q-tag® CLm doc LR E006/032
Ref: Supplement 15; Temperature and humidity monitoring systems for transport operations, Technical supplement to WHO
Technical Report Series, No.961, 2011: Annex9, August 2014
32
PROTOCOL TEMPLATE
g. Methodology
Step 2 Designate the mapping team
• Identify and list the team members. Record their

signatures and initials so that signed records can
be traced back to the person who prepared the
document.
• All team members receive the training needed to
perform their assigned tasks.
33
PROTOCOL TEMPLATE
g. Methodology
Step 3 Survey the site
• Calculate the total volume of the vehicle to be mapped.

• Drawing of each area showing air conditional location.
• Calculate the number of data loggers required for
mapping
34
PROTOCOL TEMPLATE
g. Methodology
Step 3 Survey the site
2.34 m
35
PROTOCOL TEMPLATE
g. Methodology
Step 4- Establish acceptance criteria
• The temperature shall be not more than 25 °C at any

point of transportation vehicle during entire duration of
temperature mapping.
• The temperature should be maintained within the defined
temperature limits except for a maximum of 30 minutes
following the door opening.
36
PROTOCOL TEMPLATE
g. Methodology
Step 5-Determine data loggers locations:
• Length and width:

• Data loggers should be arranged in a grid fashion along the
width and length of the area located every 5-10 metres.
• Should be consider The degree to which products may affect
airflow
• Height:
• If the ceiling height is 3.6 meters or less, position data loggers
directly above one another at high, medium and low level.
• If the ceiling height is greater than 3.6 meters, data logger
can be arranged in vertical arrays at the bottom, middle
(multiple) and top of the space.
37
PROTOCOL TEMPLATE
g. Methodology
Step 5-Determine data loggers locations:
Position of data loggers
multiple
38
PROTOCOL TEMPLATE
g. Methodology
Step 6 – Record data loggers,

monitoring sensors and thermostat
locations:
• Record the data logger locations on a temperature

data logger location table and record the location
identification and set point for each thermostat in the
storage area
39
PROTOCOL TEMPLATE
g. Methodology
Step 7- Label and program the

data loggers:
• Label each data logger with a unique ID taken from the

temperature data logger location table.
• Enter the manufacturer’s serial number on the table for
ensures that the device can be traced to its
calibration certification.
• Set program recording interval, start time of all data
loggers must the same time.
40
PROTOCOL TEMPLATE
g. Methodology
Data sheet format for every data loggers used in the exercise
41
PROTOCOL TEMPLATE
g. Methodology
Step 8- Fix data loggers in position:

Temperature mapping
• Fix the data loggers in position making sure that placed

exactly as shown on table.
• Position and fasten the devices so that they can’t be
damaged or displaced during operations.
• Ensure that sufficient time for the data loggers to be
conditioned to the ambient temperature before the
mapping exercise begins.
42
PROTOCOL TEMPLATE
g. Methodology
Step 9- Conduct the mapping

exercise:
• It should be run for a minimum of 7 consecutive

days.
• At the end of the study, collect the data loggers,
double-check their serial numbers and locations
against the installation notes.
43
PROTOCOL TEMPLATE
g. Methodology
Step 10- Download and consolidate

the data
• Download the data loggers readings and consolidate the data for
the analysis descry
44
PROTOCOL TEMPLATE
g. Methodology
Step 11- Record the temperature

reading for analysis and evaluation.
45
EXAMPLE
Shipping pattern
Ref :Supplement 12: Temperature-controlled transport operations by road and by air,

Technical supplement to WHO Technical report series No.9612011 Annex9, August
2014
46
EXAMPLE
Process of transportation
47
EXAMPLE
Execute VERIFICATION OF TRANSPORTATION
48
REPORT TEMPLATE
h. Report template
A Introduction: a description of the objectives of the transportation

study.
Summary: a summary and discussion of the results organized in

B the sequence set out in the protocol, including a summary of
deviations (if any).
Conclusions and recommendations: a general conclusion for

C all verifications and observations indicating the acceptability of the
equipment for operation. Recommendations and remarks can be
incorporated in this section.
D
Report annexes: all the annexes to the test report
49
REPORT TEMPLATE
i. Annexes as needed, including templates for the

mapping report.
Annexes as needed: The annexes to the report should contain the
following:
• The site survey, showing data loggers locations;

• The raw data, presented using the appropriate test data sheet format
• Spreadsheet data and related temperature graphs for every data loggers
used in the exercise;
• Product in transportation vehicle form
• Raw results of the data analysis, including hot and cold spots;
• Key documents and notes prepared during the mapping exercise
• Deviation reports, including corrective and preventive actions (CAPA)forms;
• Calibration certificates for all data loggers used forms.
• Personal Identification form.
50
ANALYSIS OF DATA
Overall temperature stability, identify and list the

1 factors that explain the observed temperature variations
in the study
Analysing the data and preparing report

• Minimum temperatures (Cold spots) (lowest
2 temperature recorded in the mapped space)
• Maximum temperatures (Hot spots) (highest
temperature recorded in the mapped space)
• Mean temperature
51
ANALYSIS OF DATA
Report of maximum and minimum temperature
52
ANALYSIS OF DATA
Diagram indication maximum and minimum location
53
ROUTINE MONITORING
• During transportation, continuous monitoring and recording of

any critical environmental conditions to which the product may be
subjected should be performed.
54
RE-VALIDATION
 Depending upon the routine monitoring strategy, subsequent

mapping exercises may also be required periodically – for example,
every three years –in order to demonstrate continuing compliance.
 In situations where multiple fixed monitors provide continuous data, a

periodic re-evaluation which assesses all aspects of system
performance since the initial mapping may be more appropriate.
 In addition mapping should be carried out whenever significant

modifications are made to the store. Examples include changes in the
pattern of use that may increase loading or affect air circulation, or
changes to the refrigeration equipment, such as an alteration to the set
point.
55
Thank You For Your
Attention

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YAOWAPHA KAEWSAITA

Pilot scale section

9 MONITOR AND RE-VALIDATION

WHO Technical Report Series, No.961, 2011

EU: 30 March 2015

WHO Technical Report Series, No.961, 2011

• เนื่องจากสภาวะความแปรปรวนระหว่างการขนส่ง จึงต้องเฝ้าระวัง และบันทึกสภาพแวดล้อมวิกฤตที่อาจส่งผล

67. ผลิตภัณฑ์สาเร็จรูป • สภาวะการจัดเก็บยา (storage condition of product)

70. บันทึกต่อเนื่อง • Monitor

Objective of Verification of transportation

• Provide air temperature monitoring systems and devices

ASSOCIATED MATERIAL AND EQUIPMENT

Device types: Electronic Data Integrators (EDI).

 Storage condition each of

 The protocol should define the

 Transportation Vehicles Database

 Transportation routes should be clearly defined

 Different techniques: FMEA

 Classified : High, medium, low

 The mapping protocol should contain the following sections:

a. Approval page and change control history

b. Acronyms and glossary

 Define the acronyms and technical terms used in the protocol.

c. Description and rationale

 Describe the installation to be mapped and outline

 Clearly define the scope and purpose of the transportation

 Describe the transportation route

 The detailed objectives of the study transportation

 The validation team requires the involvement and close

The following Technical Supplements are also relevant:

Checking the Temperature and

The mapping of temperature in the finished product transportation

Step 1- Select data loggers:

• Have a time recording intervals to be set in the range

Step 1- Select data loggers:

• All data loggers must have a US National Institute of

Step 1- Select data loggers:

Berlinger Q-Tag® CLm Doc

Performance Quality Safety

Step 2 Designate the mapping team

• Identify and list the team members. Record their

Step 3 Survey the site

• Calculate the total volume of the vehicle to be mapped.

Step 3 Survey the site

Step 4- Establish acceptance criteria

• The temperature shall be not more than 25 °C at any

Step 5-Determine data loggers locations:

• Length and width:

Step 5-Determine data loggers locations:

Position of data loggers

Step 6 – Record data loggers,

• Record the data logger locations on a temperature

Step 7- Label and program the

• Label each data logger with a unique ID taken from the

Step 8- Fix data loggers in position:

• Fix the data loggers in position making sure that placed

Step 9- Conduct the mapping

• It should be run for a minimum of 7 consecutive

Step 10- Download and consolidate

Step 11- Record the temperature

Ref :Supplement 12: Temperature-controlled transport operations by road and by air,

A Introduction: a description of the objectives of the transportation

Summary: a summary and discussion of the results organized in