XI-01-VMP06

LINCOLN PARENTERAL LTD.

11, TRIMUL ESTATE, NEAR KHATRAJ CHOKDI,
TALUKA KALOL,POST:-382721
DIST:- GANDHINAGAR(GUJARAT), INDIA

TEMPERATURE MAPPING
PROTOCOL

Document No. QP-TM-F52

Supercede No. ---
Effective Date
 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 2 of 7
Location: Khatraj
1.0 APPROVAL:

1.1 This protocol is prepared by

Department Quality Assurance
Signature
Name
Designation
Date

1.2 This protocol is reviewed by

Department Quality Assurance Production Engineering

Signature
Name
Designation
Date

1.3 This protocol is approved by

Department Quality Assurance

Signature
Name
Designation
Date

1.4 This protocol is authorized by

Department Quality Assurance

Signature
Name
Designation
Date
 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 3 of 7
Location: Khatraj
2.0 TABLE OF CONTENT:

SR. CONTENT PAGE

NO. NO.
1.0 APPROVAL 2

2.0 TABLE OF CONTENT 3

3.0 OBJECTIVE 4

4.0 SCOPE 4

5.0 RESPONSIBILITIES 4

6.0 RATIONALE 5

7.0 PERFORMANCE EXPERIMENTAL PLAN 5

8.0 ACCEPTANCE CRITERIA 6

9.0 REFERENCE 6

10.0 REVALIDATION CRITERIA 6

11.0 LIST OF ANNEXES 6

12.0 REVISION HISTORY 7

 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 4 of 7
Location: Khatraj
3.0 OBJECTIVE:

5.1 The fundamental purpose of the mapping study is to identify temperature variations affecting the chosen first
floor packing hall at the time of the study is being conducted. In order to observe the effect of seasonal variation,
one should be carried out during the warmest season and one during the coldest season. This will establish
whether the mapped area is able to maintain required temperature throughout the year.

4.0 SCOPE:

5.1 This Protocol is applicable to the Temperature Mapping study in First floor packing hall situated at
Lincoln Parenteral Ltd at Khatraj plant

5.0 RESPONSIBILITIES:
5.1 Quality Assurance
5.1.1 Preparation of protocol

5.1.2 To verify the step-wise instruction mentioned in protocol are performed

5.1.3 Distribute Calibrated temperature recorder at pre defined location as per protocol

5.1.4 Record the result and compile the protocol.

5.1.5 Report any deviation/non-conformance to QA Manager/QA Head and take corrective and
preventive action in coordination with respective department.

5.1.6 To Execute validation as per cGMP requirement and organization’s Quality norms.

5.1.7 Review & approval of raw data generated during the process and conclude the findings for
final acceptance / rejection of the study.

5.1.8 Inform Head QA for any deviation / non-conformance. Investigate jointly and submit the
report to Head QA.

5.1.9 Review and approval of protocol and report.

5.2 Production
5.2.1 Review of protocol and report

5.2.2 To provide required support during study.

5.3 Technical/Engg. Department

5.2.1 To provide required technical support during study

 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 5 of 7
Location: Khatraj
6.0 RATIONALE

6.1 Temperature mapping study is carried out to determine the temperature distribution pattern throughout
the Packing area. To determine the worst-case location for routine temperature monitoring, temperature
recording devices to be placed at predefined locations. Temperature to be recorded at predefined
frequency (every 15 minutes). Statistical techniques are used to calculate maximum temperature,
minimum temperature and average temperature for each location. Worst-case location can be
determined based on observed maximum temperature and/or average temperature (maximum).
6.2 Temperature mapping study of Packing area shall be carried out with reference to seasonal variation i.e.
peak winter and peak summer.
6.3 Data Loggers shall be kept geometrically as per room layout as attached to this protocol (Refer
Attachment-II), to cover all location.
6.4 On the basis of temperature monitoring worst-case locations shall be defined for routine monitoring.

7.0 PERFORMANCE EXPERIMENTAL PROCEDURE:

6.2 Selection of Data logging device:

6.2.1 All loggers must be calibrated and valid during the study.
6.2.2 Calibration certificates for each of the data loggers used in the study shall be available.
6.3 Data logging device location:
6.3.1 Length and Width: Data logging devices shall be arranged in a grid fashion along the width
and length of the area so that the area is reasonably covered, with locations approximately
every 5-10 m. in very large facilities, this can be up to 20 or 30 m.
6.3.2 Height: Ceiling height is 3.6 m or less, position the data logging devices directly above one
another at high, medium or low level. If the ceiling height is greater than 3.6 m, data loggers
shall be arranged in vertical arrays at the bottom, middle and top of the space. (Refer
Attachment II for the location of loggers and numbers of loggers required)
6.3.3 Room size - Length 15.72 m and 9.78 m, Height 2.40 m, Width 6.0 m and 8.61 m.
6.3.4 Data logging devices for verification, at least one device shall be placed near supply duct at
top shelf and near door.
6.3.5 Place at least one logger outside of the room for the verification of outside (ambient)
temperature.
6.3.6 keep data loggers at predefined locations as per Annex-III of area.
6.3.7 Start data loggers to record the temperature, placed at different locations in room for 07 days
for 15 min print interval.
6.3.8 Calculate maximum temperature and minimum temperature for each location by taking all the
recording element (inside room) readings into consideration. Calculate mean kinetic
 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 6 of 7
Location: Khatraj
temperature and maximum mean kinetic temperature among all the recording elements (inside
room).
6.3.9 Collect the print out and review the recorded temperature & humidity. (As applicable)
6.3.10 Make corrections or modifications in the existing pattern/system, on the basis of the results
observed.

8.0 ACCEPTANCE CRITERIA:

7.1 The Temperature Should not more than 25 °C

7.2 Worst case location must be determined for routine temperature monitoring on the below basis.
7.2.1 Location with maximum temperature.
7.2.2 If maximum temperature achieved at more than one location, maximum average temperature
shall be considered as worst case among the maximum temperature location.

9.0 REFERENCE:

Sr. No. Reference Detail Document No.

Supplement-8, Annex
Model guidance for the storage and transport of time and temperature
9.1 9: WHO TRS, No:
sensitive pharmaceutical products.
961,2011

10.0 REVALIDATION CRITERIA:

Temperature Mapping shall be done every 3 years ± 1 month.

11.0 LIST OF ANNEXES:

Following annexes are attached with this protocol:

Annex Name of annex
I Calibration status of the Instruments
II Location of the probes for Temperature Mapping study
III Diagram Indicating the position of probes including the hot point
IV Result of temperature mapping study
 XI-01-VMP06
TEMPERATURE MAPPING PROTOCOL
Document Name : Temperature Mapping Protocol of First Floor Packing Hall
Document No.: QP-TM-F52 Page No.: 7 of 7
Location: Khatraj
12.0 REVISION HISTORY:

Revision Change control Reason for Changes incorporated

No. No. revision

00 LPL/CC/17/091 New Packing Facility Temperature Mapping for New

Packing hall