Questionnaire

In accordance with the requirements of the Guideline on Good

distribution practice for medicines and SR ISO 9001: 2015, S.C.
RUBICON PHARMACEUTICALS S.R.L., wishes to continually
evaluate its external suppliers of products and services needed to
carry out our business.
One of the methods of selection and evaluation of the external
vendor quality management system is the use of the " evaluation
questionnaire".
For this reason, please fill in this questionnaire and then submit it to
include your organization on the "List of accepted external
suppliers".

In the hope of a good colaboration,

Thank you,

Responsible for Quality,

Pharmacist Tarala Diana

...........................................

Date: ............................
 EVALUATION QUESTIONNAIRE

A. GENERAL DATA ON THE ORGANIZATION

Company name:

VAT:

1. Company:
Address:

Legally representative:

Office:
2. Addrese:
Warehouse:
3. Contact persons:
(first name, last name, position held, e-mail, phone NU.)

Persponsible Person:

Commercial:

Accountancy:

No./ Date of issue:

WDL
Valid until:
4. Authorizations:
Psychotropic and narcotic No./Date of issue:
authorization Valid until:
No./Date of issue:
Certificat GDP / GMP
Please attach a copy Valid until:
of your
authorization
Others:

5. Banking Bank:
information: IBAN:
6. Have there been any changes in the company in the last 3 years (eg: registered office,
owner, RP, secondary office, etc.)?

YES

NO

if „YES”, please specify:

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 B. EVALUATION QUESTIONNAIRE:

1. Personnel:

What is the total number of employees of the company and how many of them are responsible
for the quality of the products distributed?

- within the company, are the Rules of Good Distribution Practice and YES NO
product integrity observed?

- there is an employee responsible for quality management? YES NO

- job descriptions are available for all key positions in the company? YES NO

- the activity of the person responsible for quality management is

YES NO
carried out according to job description?

- Is there a training program (initial and periodic) for all staff,

YES NO
including compliance with the Rules of Good Distribution /
Manufacturing Practice?
- Are there any records documenting the training performed for each
YES NO
position in the organization chart?
2. Payment terms:

On delivery 30 days more than 30 days

with payment order cash

Other:

3. Please state facilities granted to your loyal clients :

discounts
priority of delivery
free shipping
payment term
Other
4. Compared to the average prices on the market, your prices are:

below average at the medium level above average

5. INFORMATION ON THE QUALITY MANAGEMENT SYSTEM

5.1. Is there a quality management system in place?

YES NO

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 5.1. if YES, what reference standard have you adopted as a model?

5.2. What is the stage of the quality management system?

5.3.
being documented implemented
Documented Certified*
being implemented

* Please attach a copy of the certificate to the questionnaire

5.4. Do you have other certifications / accreditations / authorizations?

YES NO

if YES, please attach a copy of them to the questionnaire

5.5. 5.5. Do you have an external supplier qualification system? if YES, what are their
evaluation and selection criteria?

The purchase of products is made from:

manufacturer
importer
MAH
wholesalers
brokers
other (please specify)

Is there a procedure in place for the periodic evaluation / re-evaluation and qualification of
suppliers? YES NO

Do you always make sure that the supply of medicines is made only from legal sources of
purchase, according to GDP/GMP Norms? YES NO

5.6. Is the organization prompt in correspondence and resolving any complaints? Specify
the term for handling complaints.

24 hours 48 hours more, as appropriate

5.7. What is the handling of complaints?

replacement of the claimed product

return of the claimed products and cancellation of the order

Other:

5.8. How do you ensure customer satisfaction?

5.9. Do you inform your customers about the new products you provide?

Specify how:

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 5.10. After being included in the "List of accepted external suppliers", do you agree to
evaluate your quality management system / organization by conducting second-party
audits at your premises?

YES NO

6. PRODUCT DELIVERY INFORMATION

6.1. Delivery methods:

at the client's premises at the supplier premises through its own fleet

by courier outsourced transport

Other:
6.2. Delivery times:

6.3. How you pack products:

6.4. What are the documents that accompany the products you provide and attest to their
quality?
Certificate of analys YES NO
Certificate of conformity YES NO
ECMA or EMEA authorisations YES NO
Temperature graph during transport YES NO
EC Declaration of conformity (for medical devices) YES NO
EC Certificate YES NO
Other documents* YES NO
*please specify:

If needed, you can provide information about the entire distribution chain

YES NO

6.5. Which of the following products are found in the company's portfolio?

RX medicines psychotropic and narcotic medicine OTC medicine

Food supplements Medical devices Cosmetics

Other:

6.6. What are the categories of customers to whom you supply medicines? (pharmacies,
hospitals, warehouses, others) __________________________________

6.7. The company has implemented a customer qualification plan?

YES NO

Medicines are distributed only to:

 wholesale distributors
 community pharmacies
 hospitals
 persons entitled by the Ministry of Health to provide medicines to the population
 Others (specify):
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 6.8. Storage spaces and equipment
Do you have your own storage space? YES NO

Otherwise, please provide us with the names of your logistics partner

and his authorization.

...................................................

Are there clearly delimited spaces, according to GDP/GMP, allocated for YES NO
carrying out the operations of reception, storage and handling,
collection and dispatch?
Have you implemented a controlled access system for the storage area? YES NO

What temperature can you ensure in the storage areas?

15-25° C

2-8° C

Other (specified):____________________________

Are there special storage spaces for heat-sensitive products (+02 - + 08 YES NO
° C)?
Have special spaces been arranged for the storage of quarantined YES NO
products?
YES NO
Are storage spaces provided for products withdrawn from the market,
as well as for expired and / or damaged products to be destroyed?

Are the storage spaces equipped with control and monitoring equipment YES NO
for temperature and humidity conditions?
Are these equipments checked and calibrated periodically? YES NO

if "YES", at what time interval?

Are temperature and humidity monitored, controlled and recorded? YES NO

YES NO
Has thermal mapping of all spaces been performed in order to
determine the location of the sensors for temperature / humidity
monitoring?
YES NO
Is the system provided with pre-alarm and alarm of temperature and
relative humidity deviations? Specify how the alarm is performed
_______________________________
YES NO
Are the records on cleaning operations as well as those on disinsection,
disinfection and rodent control of the premises archived and can they
be checked if necessary?
Is security and protection of the premises provided 24 hours a day, 7 YES NO
days a week?
Computer system: YES NO

- does it monitor the traceability of a batch of products from entry to

exit? YES NO
- does it respect the rotation of FEFO stocks?

- Is he qualified? YES NO
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 Do you have a documented maintenance procedure? YES NO

Are there concluded contracts for the maintenance of essential YES NO

equipment?

Is the disposal of hazardous waste as well as the destruction of out-of- YES NO

circulation medicines ensured and carried out by an authorized
company?

6.9. Information on reception and storage activities:

Is there a documented procedure for receiving and verifying medicinal YES NO
products?
What are the checks performed at the reception:

 physical seal number correspondence - CMR (if applicable)

 temperature monitoring during transport from supplier to warehouse
 integrity of pallets and integrity of secondary packaging
 quantity / lot delivered versus documents
 the existence of quality documents for each batch delivered
 product registration according to APP + annexes
 listing RXs in CANAMED
 others (specify):
At the reception, is the authenticity of the unique identifier in EMVO YES NO
and the integrity of the protection device against illicit modifications
verified?
Is there a documented procedure for storing medicinal products? YES NO

Are there segregated areas dedicated to products intended for YES NO

destruction / quarantine / withdrawal / return / counterfeiting?
6.10. Counterfeit Pharmaceuticals

Is there a documented procedure for counterfeit or suspected YES NO

counterfeit medicines?

Are the provisions on the prevention of the entry of falsified medicinal YES NO
products into the legal supply chain as specified in Directive 2011/62 /
EU and Delegated Regulation (EU) 2016/161 complied with?
Will you inform the competent authorities and the MAH immediately YES NO
about any counterfeit products identified or suspected of
counterfeiting?
How do you ensure that you do NOT allow counterfeit medicines to enter the distribution
chain?

6.11. Withdrawal of drugs and other pharmaceuticals

- is there a documented procedure for the withdrawal of medicinal YES NO
products / pharmaceuticals from the market?
YES NO
- is an annual simulation of this process performed?
YES NO
- inform customers immediately in case of withdrawals?

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 6.12. Complaints and Return of Pharmaceuticals

s there a documented complaint procedure?

YES NO
Mention the time to resolve a complaint____________________
YES NO
Is there a documented procedure for returning the products?

Do you accept the return of medicines?

if 'YES', who approves the return of returned products to marketable YES NO

stock and under what conditions?

________________________________________
Products returned by customers are subject to quality control before YES NO
being returned to the stock with?

Is there any documentation to verify the quality of the returned YES NO

products?
6.13. Information regarding the transport activity:
Is there a documented procedure for transporting medicinal products? YES NO

The transport of the products is done with:

YES NO
- Own fleet
- Outsourcing the transport service
YES NO

Are the vans used for transport qualified in terms of the performance of YES NO
the system for ensuring the temperature and humidity conditions during
the transport period?
Are the vans checked periodically from a technical point of view? YES NO

Do you transport “cold” products - 2-8 C? YES NO

Do you keep records of the temperature during the period YES NO

Of transport ?
Are the monitoring and recording resources of temperature and YES NO
humidity in transport vehicles regularly calibrated?
if "YES", how often? ___________________
When was the last calibration performed? _________________
Do you have a backup system for recording the temperature during
transport? YES NO

Is the sanitation of transport cars done regularly? YES NO

6.14. Outsourced services:

Do you use services provided by contract beneficiaries as defined in the YES NO

Good Distribution Practice Guide?

if “YES” please list these outsourced activities

____________________________________________

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 Have you concluded quality agreements with your subcontractors? YES NO

Has the beneficiary of the contract been qualified according to the GDP /
GMP requirements?
YES NO

The questionnaire was completed by:

Stamp and
Name Position held Date
signature

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