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NPL-SOP-07-PC-010000-6/9.

Questionnaire for Original Manufacture (Raw Material)

1. GENERAL INFORMATION

1.1 Company Name & Legal Status ………………………………………………………….……………………….


1.2 Type of product provided
…..…………..…………………………………………………………………………………………………………
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…………………………………………………………………………………………………………………………
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2. ADDRESS – PHONE – FAX - CONTACT PERSON – WEBSITE/EMAIL

2.1 Commercial Headquarters …………………………………………………….……………………………...……


…………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………
Phone…………………………………………………………Fax………………………………………………….
Contact Person:
1…………………………………………..Position ……………………………Email…………………………….
2 ………………………………………….Position ……………………………Email…………………………….
3…………………………………………..Position ……………………………Email…………………………….
2.2 Factory (if on different site) …………………………………………………………..………………………..….
…………………………………………………………………………………………………………………………
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Phone…………………………………………………………Fax………………………………………………….
Contact Person:
1…………………………………………..Position ……………………………Email…………………………….
2 ………………………………………….Position ……………………………Email…………………………….
3…………………………………………..Position ……………………………Email…………………………….

3. ORGANISATION
Please enclose your Company organigram (organization chart)

4. MARKET

4.1 Main customers


….………………….……………………………..…………………………………………………………………..
……………………………….…………………………………………………..……………………………………
……………………………….……………………………………………………..…………………………………
4.2 Main foreign customers / countries
………………..……………………………..……………..........................................……………………………
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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

QUALITY SYSTEM

CERTIFICATION
1. Has the facility been inspected by governmental? Yes No
If yes, please state date and outcome of the last one
……………………………………………………………………………….
………………………………………………………………………………………………
………………
………………………………………………………………………………………………
………………………………………………………………………………………………

2. Is your Quality System certified according to:


a. ISO 9000? Yes No
b. ISO 17025? Yes No
c. GMP? Yes No
d. KAN? Yes No
e. Others …………………………………………….
If so, please enclose a copy of your certificate

3. Describe the scope of your certified system


………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………………………………………………………
4. Do you produce: Yes No
a. Betalactam Yes No
b. Cephalosporin Yes No
c. Hormone Yes No
d. Cytotoxic anti-cancer agents
Yes No
5. Beside Pharmaceutical material, do you produce pesticides and/or herbicides? Yes No
Does it produced in the same manufacturing site?
If you produce other product, please state the type of product
………………………………………………………………………………………………
………………………………………………………………………………………………
………………………………………………………………………………………………

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Quality System Rating:


Rating Meaning Interpretation
5 Very Good Condition works very good (> 80%)
4 Good Condition works good, Item/area/system/
knowlegde meets average requirement (71-80%)
3 Adequate Item/area/system/knowlegde meets basic minimum
requirement (61-70%)
2 Poor Item/area/system/knowlegde is week and not up to
acceptable standards (31-60%)
1 Unsatisfactory Item/area/system/knowledge is missing or of such
nature to warrant serious quality / compliance
concern (0-30%)
NA Not Applicable Question is not applicable to type of operations or
items was unable to be addressed during the audit
Score
No. Questions
NA 1 2 3 4 5
A PERSONNEL
1. Do you have sufficient number of experience and qualified academic personnel
(ex Pharmacist, Veterinary, Chemist, Biologist)?
Please give description
………….……………………………………………………………………………….…………
………………………………………………………………………………………………………

2. Do you keep record for all your employee about their competencies?
Please attach the document (example)
3. Do you have written document about job description for critical function (prod,
QC, QA, R&D)? Please attach the document
4. Do you implement training program for all your personnel regularly?
5. Do you keep the record history of training for all employees?
Please attach the document (example)
6. After training, do you perform assessment?
Please attach the document (example)
7. Do you implement medical check up for new employee?
Please attach the document (example)
8. Do you implement periodical medical check up for current employee?
Please attach the document (example)
9. Do you hire consultant for advising on manufacture
If yes, how sufficient his/her education, training, and experience?
Please attach the record stating the name, address, qualifications and type of
service provided by these consultant.

B PERSONNEL HYGIENE
1. How adequate your gowning procedure to avoid cross contamination?

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Score
No. Questions
NA 1 2 3 4 5
Please attach the procedure
2. Do all your personnel has been trained about hygiene
Please attach the training attendance (example)
3. Do all your personnel practice good sanitation and health habits
4. Do you have regulation to forbid your personnel from:
a. Eating, smoking, drinking, chewing in production area
b. Engage in production activities when they suffering infectious disease
Please attach the written regulation
C FACILITIES
1. Do your facilities always clean and orderly?
Please attach the photo of your facilities
2. Have you define your area for the following activities:
a. Receipt material
b. Quarantine material
c. Sampling material
d. Rejected material
e. Release material
f. Production operation
g. Packaging and labeling operation
h. Laboratory operation
Please attach your facilities mapping
3. How adequate the design in production area to avoid cross contamination and
mix up? Please attach the photo of production area
4. How adequate the design in production area to separate the material flow and the
personnel flow to prevent cross contamination and mix up?
Please attach the flow mapping
5. In production area, are area classes adequately defined?
6. How adequate the warehouse area to separate incoming, quarantine and
outgoing product? Please attach the photo of warehouse area
7. Does your building used for manufacture properly maintained?
8. How adequate your system to restrict the access to enter
a. Warehouse Area
b. Production Area
c. Laboratory Area
d. Document Area
Please enclose the photo showing security system for entering those rooms
9. How adequate your lighting in all areas to facilitate operations?
10. In production area, do you control and monitor
a. Particle contamination
b. Microbiological contamination
c. Temperature and humidity

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Score
No. Questions
NA 1 2 3 4 5
d. Pressure differentials
e. Air Exchange
f. Insect, rod, pest to avoid entering the production area
Please attach the data (example)
11. In warehouse area, do you control and monitor
a. Temperature and humidity
b. Insect, rod, pest to avoid entering the warehouse area
Please attach the data (example)
12. Does your monitoring data always show normal condition / complies with the
requirement?
D. UTILITIES
1. Do you have:
a. Adequate ventilation system, air filtration, air conditioning
b. Adequate water system
2. Have you perform qualification for all your utility
Please attach the document
3. Does your water monitoring always show normal condition / complies with WHO
requirement
Please attach the document
4. Do you have room with this requirement:
a. 100.000 cuft Yes No
b. 10.000 cuft Yes No
c. 100 cuft Yes No
E. CLEANING AND SANITATION
1. Are there cleaning schedules for all production rooms?
Please attach the document (example)
2. Are there cleaning procedures for all machines?
Please attach the document (example)
3. Do all your machines always cleaned?
4. Do you document all cleaning record in logbook?
Please attach the document (example)

F. MANUFACTURING PROCESS
1. How adequate your ‘line clearance’ procedure?
Please attach your procedure
2. Is there a manufacturing procedure every time manufacturing process?
Please attach the document
3. Is there a packaging and labeling procedure every time packaging and labeling
process? Please attach the document
4. How adequate your batch to batch uniformity?
Please attach the manufacturing flow (example)

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Score
No. Questions
NA 1 2 3 4 5
5. How adequate your procedure for handling deviation occurs during process?
Please attach the procedure
G. MAINTENANCE AND CALIBRATION EQUIPMENT / MACHINE
1. Do you have list of equipment/instrument covering your entire instrument?
Please attach the document
2. Do you have written procedure covering all your instruments about
a. Instrument Operational?
b. Instrument Maintenance?
c. Instrument Calibration?
Please attach the document (example)
3. Do you have preventive maintenance and calibration schedule covering your
entire instrument?
Please attach the document
4. Are all instruments and machine
a. Maintained?
b. Calibrated (for measuring device)?
5. Are the calibration weights certificated regularly?
Please attach the certificate copy (example)
6. Do you archive all record of all
a. Maintenance activities
b. Calibration activities
c. Non Routine repairmen
Please attach the record (example)
H. QUALITY CONTROL
1. Is there acceptable area for sampling?
Please attach the photo of sampling area
2. Is there acceptable procedure for sampling?
Please attach the procedure
3. How adequate your identification procedure to identified product status (released
item, awaiting for testing item, rejected item) Please attach the procedure
4. How adequate your reagents and solutions in the lab areas labeled to indicate:
a. Identity
b. Titer or concentration
c. Storage requirement
d. Expired date
Please attach the photo of your reagent
5. How adequate your control system to assure that all your reagent and solution
kept in appropriate condition
6. How adequate your methods validation?
Please attach the protocol validation
7. How adequate your follow-up stability procedure?
Please attach the stability protocol

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Score
No. Questions
NA 1 2 3 4 5
8. How adequate your retain sample storage?
Please attach the photo of your retain sample storage
9. Do you have procedure for result out of specification?
Please attach the procedure
I. DOCUMENTATION
1. Do you have procedure for:
a. Document issuance
b. Document revision
c. Document superseding
d. Document withdrawal
2. Do you have Standard Operating Procedure (SOP) for all your activities
3. Do you review the SOP periodically
4. Do all logbooks adequately kept?
5. Do you control all changes through change control system?
Please attach the document
6. Are records and report retained for the length of time?
J. SUPPLIER QUALIFICATION
1. Do you have list of all your supplier
Please attach the document
2. How adequate your supplier qualification
3. Do you conduct supplier audit for all your supplier
Please state your supplier that has been audited by your company
……………………………………………………………………………………………
……………………………………………………………………………………………
……………………………………………………………………………………………

4. Do you evaluate all your supplier performance


Please attach the document
K. PRODUCT QUALITY REVIEW
1. Have you review all your product quality annually?
Please attach the document
L. COMPLAIN
1. How adequate your procedure for handling complains?
Please attach the document
2. Do you always analyze all internal and external complain?

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NPL-SOP-07-PC-010000-6/9.0

Questionnaire for Original Manufacture (Raw Material)

Score
No. Questions
NA 1 2 3 4 5
M. SELF AUDIT
1. Do you have schedule for carry out annual self-inspection?
Please attach the document
2. Have you implement self-inspections periodically?
3. Have you documented your audit finding and corrective action?
4. Have you complete your corrective action in a timely and effective manner
N. WASTE HANDLING
1. Do you have adequate procedure for handling waste in your company?
2. Do all your waste dispose in a safe, timely, and sanitary manner?

VERIFICATION AND APPROVAL OF THE QUESTIONNAIRE

SUPPLIER SIGNATURE & STAMP


Date:

( )

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