Assessment Questionnaire

This Questionnaire applies to Contract Research Laboratory /Contract Manufacturing

Organization/ Vendor providing services to Fusion Scientific Labs Pvt. Ltd. Please complete all
the sections as fully as possible in indelible ink, indicating the parts that are not applicable to
your company. Please ensure that all sections are completed and that your company stamp and
initials are on each page.

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 Assessment Questionnaire
A. Organization Details:

1. Name of the Company

2. Address

City

State

Postcode

Country

Telephone number

Fax number

Web address

3. Year of Establishment

4. License No and Valid upto

5. E-mail address and telephone number

of the contact person

6. How many testing sites does your

company have?

7. Approximate size of the site

8. Approximate number of employees

(Attach list of key employees with
qualification, and years of experience)

9. Name the departments in your

organization
(Attach company Organogram)

10. Does your company have a web site

that provides an overview of
activities?

If so, please specify:

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 Assessment Questionnaire

Sr. Title Yes No N/A Remarks (if any)

No
1.0 GMP status
1.1 Is your facility is GMP approved?

2.0 Quality Related Information

2.1 Do you have a written quality policy and/or
quality manual or equivalent document approved
by the company management?
If yes, please enclose a copy
Enclosed Not Enclosed
2.2 Is the Quality Unit independent from the other
departments?
2.3 Do you agree to periodic compliance audits
performed or arranged by your customers?
2.4 Do you have procedures covering the release and
reject of the end product?
2.5 Are batch records reviewed /approved before the
batch is dispatched?
2.6 Do you have a procedure for Self-Inspection?
If Yes, specify frequency___________________
2.7 Do you have a Change control procedure in
place?
2.8 Are deviations, Incident investigated and
documented?
2.9 Do you notify your customer for any major
changes?
2.10 Are certificate issued by each batch, who signs
the certificate of analysis (analytical report before
release)
3.0 Personnel, Training & Education
3.1 Do you have written procedure for Medical
Health Checkup?
3.2 Do you have written job descriptions for all
personnel?
3.2 Do you have approved technical staff?
(Attach a list of Technical Approved Staff?
3.3 Do you have an Annual Training Calendar?
3.4 Does the training program include the training
requirements and quality for a new analyst?
3.5 Does a training program exist for the routine
evaluation of the competence and capabilities of
analysts that includes re-qualification of analysts?
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 Assessment Questionnaire
Sr. Title Yes No N/A Remarks (if any)
No
3.6 Is the facility cleaned and maintained according to
the written procedure?
3.7 Is all your personnel trained in GMP when
recruited?
3.8 Does written calibration program for pest
management available?
4.0 Dispensing
4.1 Is a list of approved suppliers used?
4.2 Is there a documented procedure for approval of
suppliers?
4.3 Does this include audit of suppliers?
4.4 Is there a system for monitoring or reviewing
suppliers performance?
4.5 Is a Sampling plan in place?
4.6 Is a testing plan in place?
4.7 Is there an identified sampling area?
4.8 Are all containers identified?
4.9 Is a First-In-First-Out or First-Expiry-First-Out
system in use?
4.10 Are shelf life/expiration dates used?
4.11 Is temperature and humidity controlled and
documented?
5.0 Manufacturing
5.1 Are there separate areas for
5.1.1 Handling of starting materials
5.1.2 Dispensing Area
5.1.3 Manufacturing
5.1.4 Quarantined finished products or are other control
systems in place?
5.1.5 Packing and Dispatch
5.1.6 Canteen Area
5.2 Are your working rooms
5.2.1 Of proper size for the intended functions
5.2.2 Satisfactorily lightened, air conditioned
5.2.3 Designed to avoid cross contamination
5.2.4 Supplied with security and fire protection
measurements?

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 Assessment Questionnaire
Sr. Title Yes No N/A Remarks (if any)
No
5.3 Do you manufacturing locations follow good
manufacturing practices?
5.4 Do you have clean area for pilot BE batches ?
5.5 Are supply pipelines identified and labeled?
5.6 Do you monitor the quality of the water used to
prepare standards and reagents?
5.7 Do you monitor the quality of the water used
during the manufacturing process?
5.8 Do you monitor air differential pressures between
production rooms and corridor?
5.9 If yes, do you log the pressure? And when do you
log it?
5.10 What other preventive measures to you take to
avoid cross contamination of products during
production?
5.11 Are cleaning processes validated?
5.12 Is there in-process monitoring system?
5.13 Is there an equipment use log?
5.14 Are all critical instrument Calibrated?
5.15 Is there a Preventative Maintenance Program?
5.16 Is reprocessing allowed ?
5.17 Is there a non-conformances procedure?
5.18 Is the yield checked against defined limit?
6.0 Packing
6.1 Are packing operations segregated from
production?
6.2 Are barcode readers in use?
6.3 Are areas labeled with the product being packed?
6.4 Are cleaning procedure in place?
6.5 Are controlled procedure used for issuing labels
and labeling?
6.6 Are there label reconciliation procedure?
6.7 Are there label disposal procedure?
7.0 Information Technology
7.1 Do you have a list of the computerized system
used by this facility?
7.2 Does your quality system cover the quality of
computerized system?
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 Assessment Questionnaire
Sr. Title Yes No N/A Remarks (if any)
No
7.3 Do you have access security levels for the
computerized system
7.4 Do your procedure for validation cover the
computerized systems?
7.5 Do you have anti-Virus protection?
8.0 Quality Control
8.1 Is an instrument usage log in place?
8.2 Are all instrument qualified?
8.3 Are all instrument Calibrated?
8.4 Is there a preventative maintenance program?
8.5 Are there documented procedures for sampling?
8.6 Are samples clearly labeled and stored?
8.7 Are manual calculation checked by a second
person?
8.8 Are data transcriptions checked by a second
person?
8.9 Are Samples clearly labeled and stored in
designated area before and after testing?
8.10 Is all raw data retained?
8.11 Are all standards traceable to their preparation
and the reagent used?
8.12 Are analytical method validated?
8.13 Do you perform stability testing on material
and/or products?
8.14 Does calibration performed as per written
schedule and procedure?
8.15 Do written procedure available for cleaning,
maintenance and storage of glassware /utensils?
8.16 Has cleaning validation performed for the
cleaning of glassware?
8.17 Does excel sheet used for calculations?
8.18 If yes is there any procedure for excel sheet
validation?
8.19 Is the software validated?
8.20 Does procedure available for rounding off
figures?
8.21 Is there procedure in place to establish and mange
reference standards?
8.22 Is there a procedure for documenting and
investigating out-of-specification results?
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 Assessment Questionnaire
Sr. Title Yes No N/A Remarks (if any)
No
8.23 Do you use any contract laboratories?
8.24 Have you qualified/evaluated these contract
laboratories?
8.25 Are records kept of all control results?
8.26 If yes, how long do you keep those records?
9.0 Engineering
9.1 Do you have a separate engineering department?
9.2 Was the facility qualified relative to its intended
use and have documented reports for the
following..
a. AHU
b. Clean room
c. Environment monitoring
d. Water systems
9.3 Do all your machine and equipment carry
information and calibration label?
9.4 Do you calibrate all machines and equipment
following schedule?
9.5 Is the annual maintenance activities performed
internally or are outsourced? Do you follow
maintenance schedule for all machine and other
equipment?

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 Assessment Questionnaire
This signatory above expressly recognizes that all information contained in this questionnaire is
true and sincere and declares it can legally bind the company.

QUESTIONNAIRE COMPLETED BY

Name

Position

Email Address

Phone

Date

Company Stamp and

Signature

QUESTIONNAIRE REVIEWED BY (FUSION SCIENTIFIC LABS PVT LTD)

Remarks

Name

Position

Date

Signature

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