Transport / Warehouse Quality Questionnaire

COMPANY: DHL GLOBAL FORWARDING ZONA FRANCA COLOMBIA S.A

Address: Cr. 106 No. 15 a 25 Int. 116 Mz. 18 Zona Franca

City: Bogotá D.C. State/Country: Colombia Zip/Postal Code: N/A_________

Print Name: Jhoana Ximena Solano Title: Technical Director

Email Address: j.solano_tarazona@dhl.com Telephone Number: 317 5138920

Signature: Date:

Please provide copies of the following documentation if possible:

 Current Organizational Chart

 Facility Diagram
 Current SOP Index
 Quality Manual and/or Quality Policy and/or Site Master File
 Change Control/Customer Notification Procedures
 Investigation/Deviation Procedure
 Validation Summary for Cold Chain Shipping (e.g. shipper boxes, temperature- controlled trucks)

NOTE: Enter “N/A” where not applicable. Use additional pages as needed.

GENERAL INFORMATION

1) What services do you provide to Biogen ? Do you provide any other services apart transportation?

DHL provides storage and secondary packaging service such as coding, sticker placement, and inspection

2) Please list all your locations (or Partner’s) which provide services to Biogen:

PLC Zona Franca Bogotá D.C. (services provided Storage, secondary conditioning, free zone process and
distribution.)

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
3) In what year was the company established?

4) How many people does the Company employ? 54

How many are in Quality? 5

How many are drivers?

Are there drivers dedicated to pharmaceutical transport and, if so, what number of them?

5) Do you hold Wholesale Distribution Authorization (WDA) license?

Yes No
If Yes, please provide a copy of the license certificate.

6) Do you have a Responsible Person named on the WDA?

Yes No

If Yes, please provide their name: ________________________________

REGULATORY HISTORY

7) Do you claim that your service(s) are provided according to Good Manufacturing Practices/Good Distribution
Practices (GMP/GDP)?
Yes No
If Yes, which GMP/GDPs do you claim to meet (check all that apply):

European Community:
__________________________________________________________________________________________

National Inspectorates:
______________________________________ BPM; INVIMA_____________________________
Please list which one(s)

8) Has the process been inspected by your local (national) health/medicines inspection agency? If Yes, please
provide the date(s) and a copy of the last inspection report.
Yes No
Sanitary concept issued by the secretary of health of Bogota (June 19, 2019)
INVIMA Good Manufacturing Practices (June 20, 2019)

9) Is your company accredited by any international organization (e.g. ISO)?

Yes No
If so, please provide copies of recent certificates.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
QUALITY SYSTEMS

NOTE: For the remainder of this questionnaire, you may provide a copy of the relevant internal
procedure(s) in lieu of a detailed description (where prompted).

10) Who is the primary Quality Assurance contact?

Name: Jhoana Ximena Solano Tarazona
Title Technical Director
Telephone Number: 317 5138920
Email Address: j.solano_tarazona@dhl.com

11) To whom does the Quality Unit report?

Department/Title: Head IWS

12) Do you use Quality Risk Management principles as per ICH Q9 for assessment, control, communication and
review of risks to the quality of medicinal products within your Quality Systems?
Yes No
If Yes, please describe examples of Risk Assessments performed.

There is a risk matrix, contingency plans, operational drills and business continuity plan

13) Do you have a formal process for periodic Quality Management Review?
Yes No
If Yes, please describe it or provide a copy of the latest report.

A review is carried out by the management on an annual basis where the behavior of the different management
systems is evaluated in a comprehensive manner (Quality, safety, OSH and environmental) and improvement
plans are established.

14) Please describe a training program within your Company or provide a copy of the SOP. Do you perform
periodic GMP/GDP training sessions for all employees working with pharmaceutical products?
There is a technical training program in which an annual training schedule is defined that includes topics such
as good manufacturing practices, documentation and storage, regulations, hygiene standards and others that are
required based on operational need, NC and result of audits.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
15) Do you have a system in place to review, approve and implement proposed changes for:

Documents Yes No
Equipment/Facilities/Processes Yes No

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
 If Yes, please describe it or provide a copy of the SOP.

The change control process is generated when there is modification or implementation in the installation /
infrastructure, Changes in the main processes or systems, new cold equipment chambers, temperature deviation
that requires improvements in the equipment, critical system failures or changes in information reports. Quality,
safety, environmental, regulatory are evaluated. An implementation schedule, periodic progress meetings, and
results analysis are established

16) Please describe your system of creation, approval, revision and retirement of controlled documents or provide
a copy of the SOP.

The creation of documents is carried out by the responsible process, it is checked for quality and approved with
the leader or technical direction, the documents of a client's operation are reviewed by him, change control and
training are carried out. The document review is carried out every 2 years or when required, its publication is
carried out in an intranet document repository in which implementation, expiration and obsolete dates are
controlled. The quality department performs a monthly review of the system. The creation of documents is
carried out by the responsible process, it is checked for quality and approved with the leader or technical
direction, the documents of a client's operation are reviewed by him, change control and training are carried out.
The document review is carried out every 2 years or when required, its publication is carried out in an intranet
document repository in which implementation, expiration and obsolete dates are controlled. The quality
department performs a monthly review of the system

17) Which types of documents are covered by your documentation system (tick all that apply):

Policies (Corporate/Departmental)
Standard Operating Procedures (SOPs)
Forms/Work Instructions/Check Lists
Qualification/Validation Protocols/Reports
Temperature results for shipments/storage
Technical/Quality Agreements
Internal Audit Reports
Supplier/Service Provider Qualification records
Quality Management Reviews
Deviations/Complaints/Change Control records
Recalls records
Returns records
Destruction of Obsolete Materials
Training Records

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
18) Are official copies of controlled documents maintained as paper copies or electronic files?

Hard copies
Electronic files
Please tick as appropriate.

19) Is there an Internal Audit or Self-Inspection Program? Yes No

If so, please describe it or provide a copy of the SOP.

Annually a schedule of internal audits is established by the BPO area, defining the scope according to the
certifications, customer requirements, DHL internal and regulations applicable to the audited operation, taking
into account the results of previous internal and external audits, report of management review, documentation of
the process and established guidelines.
The periodicity is determined according to the conclusions of previous audits, risk assessments, environmental
impact, legal impact, customer requirements, management requirements, KPI results, implemented change
controls, among others. With a minimum of 1 time every three years.
With the audit, the process must propose within a month corrective actions taken sufficient and acceptable
measures, follow-up and closure is carried out. Any non-conformity must be monitored until its closure.
Closure: it is recommended to close the Non-Conformity within 3 months or justify an extension of the term

20) Is there a system in place to monitor suppliers and/or service providers? Yes No
If so, please describe it or provide a copy of the SOP.

DHL has a department in charge of selecting suppliers according to the needs requested by the operation,
applying safety inspections and compliance with the requirement, this is included in the list of Suppliers 4279
(CO) and annually a profiling and evaluation is carried out of the service where the impact of the service on
operations, legal aspects, quality, safety and environmental management system is measured. Critical suppliers
are audited every 2 years by the BPO area. The supplier's qualification must exceed 75%, otherwise it must
generate an action plan with a follow-up of improvement at 6 months. Procedure 4233 (CO) evaluation and
qualification of suppliers.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
21) Do you have and maintain an Approved Supplier/Service Provider List? Yes No

22) Is there a system in place to qualify customers (for Pharmaceuticals)? Yes No

If so, please describe it or provide a copy of the SOP.

23) Is there a process for reporting, segregation and handling of potential falsified medicines?

Yes No

If so, please describe it or provide a copy of the SOP.

24) Do you have a formal complaint investigation system? Yes No

Please describe how customer complaints are handled or provide a copy of the SOP.

Any complaint or non-conformity generated is included in the intranet generating a consecutive traceability
notifying the client of the creation within 24 hours, the investigation, immediate actions, cause analysis, root
cause, action plan, follow-up and closure are reported in the Eshare IWS CO system and they are notified to the
client within 5 business days as well as the closing of the shares. A follow-up is conducted six months after
closure to assess the effectiveness of the action plan. Procedure ID 3224 Manejo de Quejas, desviaciones y no
conformidades.

25) Is there a system in place to capture deviations/exceptions from procedures or equipment operating parameters?

Yes No

If Yes, how is Biogen notified of exceptions that affect our products?

DHL has a platform called Eshare, which is fed by all the deviations presented in the client's operation, is
monitored by the quality area, for the correct closing and execution of the proposed activities to mitigate the
appearance of new deviations.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
26) Is there a written procedure describing the investigation of deviations/exceptions? Yes No

27) Is there a written procedure describing Corrective and Preventative Action (CAPA) planning, tracking and
closure?
Yes No

28) Do you have a written procedure(s) detailing the products/materials handling for shipments, storage, receipt and
despatch?
Yes No

29) Do you have a checklist of all documents that need to be reviewed as a part of product transportation?

Yes No

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
OPERATIONS/MATERIALS CONTROL

30) Do you ship FTL or LTL for Biogen? Please describe.

31) Are the trailers used to transport Biogen products dedicated solely to Biogen use?

Yes No

32) Are the trailers used to transport Biogen products dedicated solely to pharmaceutical transport?

Yes No

33) Do you use only temperature-controlled vehicles for Biogen products? Yes No

If no, please describe.

The transport is carried out in vehicles at room temperature, the products are distributed under the configuration
provided by biogen to guarantee the conditions established by the manufacturer.

34) Do you store Biogen products at any intermittent location during transit? or do you use a cross-dock for
temporary storage of Biogen products?
Yes No
If Yes, please describe.

35) What security measures do you provide for high value products? Please describe.

36) Do you validate your shipping lanes? Yes No

If Yes, please describe how you validate it.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
37) Do you process and manage any temperature excursions accounted during transit or temporary storage?

Yes No

Please describe the process for handling of temperature excursions.

1) Do you have an electronic (computerized) inventory system? Yes No

If Yes, please describe the scope of the system, (i.e. is it used both for inventory control and shipment tracking)
and its validation status.

2) Please provide a detailed description of the environmental monitoring program (i.e. temperature/humidity) for
the storage areas, include elements of controlled parameters, monitoring and frequency of re-qualification. (NA
if not applicable).

EQUIPMENT

38) Are your trailers equipped in GPS tracking? Yes No

39) Have the temperature-controlled trailers been validated? Yes No

40) Did the validation work include temperature mapping? Yes No

41) Please describe the validation activities performed. Include validated temperature range, number of temperature
probes/sensors used and how the final locations of probes were chosen or provide a copy of the Temperature
Mapping Study.

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
42) Please describe the program for periodic re-validation of trailers and the frequency of re-validation.

43) Is there a written calibration and preventive maintenance program for all equipment used in your operations?

Yes No

If Yes, please describe it and provide a representative schedule demonstrating calibration and preventative
maintenance frequencies.

44) Please describe the cleaning procedures and frequency for the trailers used in the transport of Biogen
materials/products.

45) In case you store Biogen materials/products or will need to store it, do your storage facilities comply with the
above criteria as well?
Yes No NA

PEST CONTROL PROGRAM

46) Is there a pest control program in place at your facilities? Yes No NA

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
 If Yes, please describe it and provide the frequency of the pest control activities. If an outside contractor
performs pest control, please provide the name of the pest control service provider.

3) Are pesticides used as part of your pest control program? Yes No NA

If Yes, are pesticides utilized within the facility (describe where inside the facility), outside the facility, or both.
Additionally, are all pesticides approved by the Quality Unit?

4) Does the Quality unit review and approve all pest control reports or results? Yes No NA

COMPUTERIZED SYSTEMS

47) Please indicate below, in which phases of your distribution/transportation/storage operations - computerized
systems are utilized and the name of the software used.

Temperature/Humidity Control
(circle which if not both conditions)

Name: ___________________

Please describe how this/these system(s) are used, what data is generated, its role in decision-making and the
validation status of the system(s).

Inventory Management

Name:

Please describe how this/these system(s) are used, what data is generated, its role in decision-making and the
validation status of the system(s).

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com
 Calibration/Preventative Maintenance

Name:

Please describe how this/these system(s) are used, what data is generated, its role in decision-making and the
validation status of the system(s).

48) Do your computerized systems comply with 21 CFR Part 11 or EU GMP Annex 11?
Yes No

49) Do you perform regular back ups of your electronic data?

Yes No

50) Do you have access control with unique logins and privileges for different users set for your electronic systems?

Yes No

51) Do you have a Data Integrity SOP/Policy?

Yes No
If so, please provide a copy of the SOP.

Thank you for filling out this questionnaire

Neuhofstrasse 30, 6340 Baar, Switzerland • Phone: +41 41 392 1700 • www.biogen-international.com