A.

Peralatan yang digunakan

– GE Kaye Validator 2000
– Thermocouple Type T ( Copper – Constantan )
– Certified Temperature Standard ( IRTD 400 Standard )
– Dry well HTR 400 ( High Temperature References ).

B. Prosedur
-
12 (dua belas) thermocouple dikoneksikan dengan GE Kaye Validator 2000®.
-
Celupkan ujung sensor thermocouple dan certified temperature standard ( IRTD 400
standard ) dalam Dry Well HTR 400 pada kedalaman yang sama dan sedekat mungkin.
-
Nyalakan GE Kaye Validator 2000®
-
Nyalakan Dry Well HTR 400 dan biarkan hingga stabil.
-
Kalibrasi dapat dimulai dengan program Kaye Validator®.

C. Kriteria Penerimaan
Perbedaan pembacaan antara IRTD 400 standard dengan thermocouple tidak lebih dari 0.5°C.

D. Hasil dan Kesimpulan

-
Lihat lampiran untuk hasil lengkap.
-
Deviasi pembacaan adalah –0.02 hingga 0.03°C dibandingkan dengan IRTD 400
standard.
-
Semua thermocouple dapat digunakan untuk kualifikasi.

II. Temperatur Distribusi (Empty Chamber).

Tanggal Pelaksanaan : 12 November 2008

A. Peralatan yang digunakan

– GE Kaye Validator 2000
– Thermocouple Type T ( Copper – Constantan ) yang telah dikalibrasi
– Sensor input modules ( SIMs )

B. Prosedur
-
Masukkan 12 Thermocouple yang telah dikalibrasi ke dalam chamber.
-
Thermocouple didistrinusikan merata di seluruh bagian chamber untuk mewakili
seluruh area.
-
Ujung sensor thermocouple tidak boleh menyentuh permukaan dari chamber.
-
Lakukan pemantauan pada suhu kondisi pemakaian normal.
-
Pemantauan dilakukan dengn interval waktu 1 menit selama 1 jam.
-
Lakukan tiga kali pengulangan dengan kondisi yang sama pada waktu sebagai berikut,
1. Pagi ( ± pukul 09.00 hingga 10.00 )
2. Siang ( ± pukul 14.00 hingga 15.00 )
3. Sore ( ± pukul 19.00 hingga 20.00 )

C. Kriteria Penerimaan

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 -
Perbedaan antara temperature yang paling panas dengan temperature yang paling
dingin tidak lebih dari 4°C.
-
Perbedaan antara temperature yang paling dingin dengan temperature setting tidak
lebih dari 2°C.
-
Perbedaan antara temperature yang paling panas dengn temperature setting tidak lebih
dari 2 °C.

D. Hasil dan Kesimpulan

-
Ringkasan hasil Temperatur Distribusi Empty Chamber diuraikan sebagai berikut:
Contents :

1. Objective.

2. Scope.

3. Responsibilities.
3.1. Validation team.
3.2. Main specific duties.
3.3. Approval.

4. Proceeding.
4.1. Documentation.
4.2. Equipment qualification and calibration.
4.3. Procedure.

5. Documentation.

6. Valid Regulation.

7. Attachment.
Contents :

8. Objective.

9. Scope.

10. Responsibilities.
3.4. Validation team.
3.5. Main specific duties.
3.6. Approval.

11. Proceeding.
4.4. Documentation.
Page 2 of 7
 4.5. Equipment qualification and calibration.
4.6. Procedure.

12. Documentation.

13. Valid Regulation.

14. Attachment.

Page 3 of 7
1.0. O b j e c t i v e

1.1. To assure that assay method what it is intended analytical application.

1.2. To provide evidence that the general system performance i.e. verification of the
wavelength and photometric scales as well as accuracy, precision and linearity are
satisfactory.

1.3. To ensure that procedure remains suitable for its intended purpose to provide
reliable test results at all times.

2.0. S c o p e

2.1. This protocol is used as the official validation protocol to verify that the assay
method is suitable for use in the laboratory.

2.2. Scope of activities.

2.2.1. Calibration of the wavelength and photometric scales ( absorbance ).

2.2.2. Precision

2.2.3. Accuracy i.e percent accuracy and percent recovery.

2.2.4. Linearity and range

2.2. To be performed for new assay or current assay when any changes are made to the
procedure i.e. changes in the composition of the drug product or change in the
analytical procedure or change in the synthesis of the drug material.

Page 4 of 7
3.0. Responsibilities

3.1. Validation team

Validation Coordinator : Management Representative.

Validation Vice Coordinator : Quality Assurance and Control Manager.
Validation Team Leader : Quality Control Manager.
Validation Team : Quality Assurance Manager.
QC Analyst

3.2. Main specific duties

3.2.1. The Team Leader together with the Validation Team are responsible for
overall adherence to this protocol :
1. Scheduling of the validation run in conjunction with appropriate unit
operation or department.
2. Monitoring of protocol completeness and calibration of equipments.

3. Providing sufficient resources with regard to the method analysis,

procedures, material, time, personnel etc.
4. Coordinating the validation run in the corresponding unit operation
involved.
5. Conducting the validation including recording and compiling all the
data.
6. Data review and solving problem may occur.
7. Preparation of validation report.

3.2.2. Quality Control Manager

Page 5 of 7
 1. Calibration of the main instrument used i.e. UV spectrophotometer.

2. Monitoring all requirements to conduct the assay i.e. reference standard,

reagents as requested by the procedure.

3. Conducting the assay of the product according to the procedure.

4. Preparation of report.

5. Reporting the status of validation to QAC Manager.

3.2.3. Quality Assurance Manager

1. Ensure that all the measurement and instrument are calibrated.

2. Compile and review all the results with the team.

3. Reporting the status of validation to QAC Manager and Management

Representative respectively.

3.3. Approval

Approval of the qualification results is given by Vice Coordinator and

Validation Coordinator respectively.

Page 6 of 7
4.0. Proceeding

4.1. Documentation

The completeness of the supporting documentations should be checked and controlled

prior validation are as follows :

April 25, 2007

4.2. Equipment Qualification and Calibration

4.2.1. The instrument i.e. UV – VIS Spectrophotometer unit used must be calibrated
before validation and the result must within the acceptable limit both for
wavelength scale as well asttachment 1.

Page 7 of 7