Rx-360 Supplier Assessment Questionnaire

Module 1: Company Information

Version 1.0 August 2014

Rx-360 Supplier Assessment Questionnaire (SAQ)

The Rx-360 Supplier Assessment Questionnaire (SAQ) was created by the Rx-360 Supplier-Led
Working Group. The Supplier-Led Working Group is an Rx-360 working group consisting of
members from both pharmaceutical companies and leading suppliers to the pharmaceutical
industry. Through this Working Group, members can share perspectives and work
collaboratively to achieve greater harmonization and efficiencies in the supply chain to better
serve patients.

Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of
resources when each individual pharmaceutical company creates its own supplier assessment
questionnaire. Suppliers routinely exhaust valuable resources continuously completing slightly
different forms of substantially similar questionnaires. In order to create the current SAQ, the
Working Group analyzed numerous sample questionnaires submitted by Rx-360 members. In
addition to standardized content, document formatting and question completion was optimized
for accuracy and ease of completion by suppliers.

The Rx-360 SAQ covers standard information that would be included in most supplier
assessment questionnaires. The 4-part questionnaire is more detailed than most, but will
decrease the number of times that questionnaires will need to be filled out by the supplier, while
significantly decreasing the turn-around time back to manufacturers. The SAQ consists of four
(4) modules:
1. General Company Information
2. Specific Site Information
3. Product Supplier Appendix
4. Services Supplier Appendix
This document is module 1: General Company Information.
Guidelines for Use
Each company using the Rx-360 SAQ will still need to interpret, assess and score the
questionnaire as they have done with their previous questionnaires. The Rx-360 SAQ is
intended to make the collection of relevant information more consistent and efficient.
Individual companies are still responsible for evaluating the questionnaires, determining any risk
to their products, and following up with suppliers for more information as needed.

Suggestions for Suppliers:

A. Complete this module on General Company Information ahead of time and have it
immediately available for manufacturers upon request.
B. Complete the Specific Site module ahead of time for each
manufacturing/packaging site within your company and have them immediately
available for manufacturers upon request.

This document is for informational purposes only. Users are responsible for ensuring that the
document meets their individual needs and adjusting it accordingly. RX-360 MAKES NO
WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, AS TO THE INFORMATION IN
THIS DOCUMENT. Complying with all applicable laws is the responsibility of the user.
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Module 1: Company Information
Version 1.0 August 2014

C. Complete Product and/or Service Specific modules ahead of time for high-
demand products so that they can be immediately available for manufacturers
upon request.

NOTE: Upon request, the pre-completed Company module can be matched with the Site and
Product/Service specific modules that the requesting manufacturer is requesting information on.
This can make the qualification much more efficient and streamlined for all parties

D. Lesser requested products can be completed upon request and matched with the
pre-completed Company and Site specific modules.
E. Use the Rx-360 SAQ for requesting information from your own suppliers.
F. Accept the Rx-360 SAQ from other suppliers and manufacturers.
G. Keep the modules updated with the most accurate information on your company,
sites, and products.
H. Suppliers with highly specialized sites or products may also attach relevant
appendix to supplement the information provided.
I. Send comments, corrections, and suggestions for improvements to the Rx-360
SAQ to info@rx-360.org.

Suggestions for Manufacturers:

A. Alter procedures within your company as needed to send out the Rx-360 SAQ for
requesting information from your own suppliers rather than a full customized
questionnaire.
B. Accept the Rx-360 SAQ from suppliers and manufacturers.
C. The current Rx-360 SAQ is very comprehensive, but if you find there are highly
specialized questions that are needed by your organization, consider creating a
short appendix that can be sent along with the Rx-360 SAQ rather than not
supporting the use of the standard SAQ.
D. Send comments and suggestions for improvements to the Rx-360 SAQ to
info@rx-360.org.

The Working Group believes the Rx-360 SAQ will create helpful efficiencies for both suppliers
and pharmaceutical manufactures alike by:

(i) Eliminating time-consuming redundancies

(ii) Streamlining the process of approving suppliers
(iii) Allowing comparative analysis of basic information.
We strongly encourage Rx-360 supplier members to use the Rx-360 SAQ for their supply sites
and Rx-360 pharmaceutical manufacturers to incorporate the Rx-360 SAQ into their supplier
assessment process moving forward. Through this greater harmonization and efficiency in the
supply chain we can all better serve patients.
Kind regards,
Rx-360 Supplier-Led Working Group Co-Chairs
Rick Calabrese, Sartorius-Stedim rick.calabrese@sartorius-stedim.com
Gary Perkins, Sigma Aldrich gary.perkins@sial.com
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 Rx-360 Supplier Assessment Questionnaire
Module 1: Company Information
Version 1.0 August 2014

Rx-360 Template Supplier Assessment Questionnaire:

Company Information
SECTION 1. General Company Information
1.1 Company Name:

1.2 Company Address:

GPS Coordinates:

1.3 Phone:

1.4 Respondent or General Quality Department Email:

1.5 Fax:

1.6 Website:

1.7 Facility Establishment Identifier/DUNS Number:

1.8 If there is an individual contact for the following areas, please provide name
and preferred contact information (at a minimum, name and telephone number
or email):
Quality:

Technical Services:

Commercial/Business/Sales:

Preferred Primary Contact :

1.9 Please list other subsidiaries operating under the company:

1.10 Please list the general product groups manufactured by the company:

1.11 Additional comments:

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Module 1: Company Information
Version 1.0 August 2014

SECTION 2. General Company Operating Information

2.1 How many years has the company been in business?

2.2 Is the legal ownership structure of the company public or private? If other, please
elaborate

2.3 If public, what is the company’s stock symbol and on which exchanges is it listed?

2.4 Does the company intend to change this structure in the foreseeable future?

2.5 How many manufacturing sites are involved in the company?

2.6 Does the company have a corporate Quality Assurance Division?

2.7 Does the company have any of the following written policies at the corporate
level? If so, please provide policy number and title.

2.7a Environmental?

2.7b Quality Assurance?

2.7c Health and Safety?

2.8 Additional comments:

I (Supplier) confirm that the information provided in this questionnaire is correct and can be
verified.
Printed Name:

Signature:
Date:
Title:
Telephone Number:
Email address: