CONFIDENTIAL

Supplier Evaluation: Drug Product

Manufacturing (IMP) Quality Questionnaire
Page 1 of 11

INSTRUCTIONS
1. Please complete this questionnaire electronically.
2. Use the  and  keys or your mouse to navigate around the form
3. Click the grey-shaded fields to enter the required information.
4. Click the grey-shaded boxes to check  or uncheck .
5. Print the completed form, then sign and date.
6. Return to DNDi along with copies of any supporting information. These may be sent electronically as PDF
files for convenience.

1. SUPPLIER INFORMATION
1.1 Supplier name:

1.2 Corporate address:

1.3 Address of manufacturing

premises:

1.4 Types of manufacturing

operations performed:
1.5 Non-sterile Dosage forms
manufactured (e.g., tablets,
capsules, semi-solids etc):
Sterile Dosage forms
manufactured (e.g. vials,
ampoules, lyophiles etc)
1.6 Scale(s) of manufacturing of
different dosage forms:
1.7 Phases of Clinical
Manufacturing Experience (I-
IV)

1.8 Storage Capabilities (CRT, 2-

8C, -20C, -70C)
1.9 Capability to manufacture
blinded drugs/placebos
(including procedures
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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assuring neither mix-ups nor

presence of potential blind-
breaking characteristics):

2. GENERAL INFORMATION
2.1 What types of materials do you package, manufacture or handle at the premises?
Pharmaceuticals? Yes No
Agricultural chemicals? Yes No
General chemicals? Yes No
Food ingredients? Yes No
Other (please specify):
2.2 Do you follow current Good Manufacturing Practices (cGMP) at the premises? Yes No
If Yes, please list which cGMP standards you follow:
2.3 Are the premises inspected by national or international health authorities? Yes No
If Yes, please list recent inspection history (health authority, date of inspection and outcomes):

2.4 Are the premises subject to any regulatory warning or enforcement actions? Yes No
If Yes, please describe these below:

2.5 Please list any additional quality accreditations (e.g. ISO 9001):

PLEASE PROVIDE COPIES OF SUPPORTING DOCUMENTATION, CERTIFICATES ETC.

3. PERSONNEL
3.1 Do you have written job descriptions for all personnel? Yes No
3.2 Do you have a written training policy or procedure? Yes No
3.3 Do you maintain training records for all staff? Yes No
3.4 Do you have a system or process to readily identify the level of compliance Yes No
with training requirements?
3.5 Does the training program include:
cGMP regulations and updates? Yes No
Quality systems? Yes No
Continuous improvement techniques? Yes No
Job specific training? Yes No
Periodic refresher training? Yes No
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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Hygiene? Yes No
Cleanliness? Yes No
Health and safety? Yes No
3.6 Please describe how the competency of staff is evaluated:

If you answered No to any of the questions of Section3 (Personnel), please use the space below to provide
additional information:

4. PREMISES, UTILITIES AND EQUIPMENT

4.1 Were the premises designed for their present use? Yes No
4.2 Are there separate areas for:
Receipt of bulk manufacturing components and materials? Yes No
Preparation and control of labelling materials? Yes No
Manufacturing? Yes No
Quarantined finished goods? (This may be controlled by an Yes No
inventory system that doesn’t require separation)
Approved finished goods? (This may be controlled by an Yes No
inventory system that doesn’t require separation)
Rest and eating? Yes No
4.3 Does the present design prevent:
Chemical contamination? Yes No
Physical contamination? Yes No
Microbial contamination? Yes No
4.4 Are any of the following materials handled or manufactured in the premises:
Beta-lactams (cephalosporins, penicillins)? Yes No
Hormones? Yes No
Cytotoxic, genotoxic? Yes No
Pesticides, herbicides? Yes No
Biological or GMO preparations? Yes No
Highly potent/toxic products? Yes No
If you answered Yes to any questions of Section 4.4, please describe specific measures
taken to prevent cross-contamination:

4.5 Do your areas for manufacturing, testing and storage have:

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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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Written cleaning or house-keeping procedures? Yes No

Environmental controls and monitoring program
Yes No
(e.g. temperature, humidity, microbial)?
A pest control program? Yes No
Security/access control measures? Yes No
If you answered Yes to any questions of Section 4.5, Yes No
are records for these available?
4.6 Has full qualification (IQ, OQ, PQ) of all utilities (e.g., HVAC, purified water, Yes No
WFI, compressed air, clean steam) that support manufacturing operations,
including equipment cleaning, been completed and documented?
4.7 Is all equipment qualified? Yes No
4.8 Do you monitor the conformance of all utilities to their quality standards? Yes No
4.9 Are plant utilities pipelines clearly identified and labelled? Yes No
4.10 Is there a maintenance/preventative maintenance program for all equipment? Yes No
4.11 Do you have written maintenance and calibration procedures for critical
Yes No
equipment?
4.12 Is there a written cleaning plan/procedure for all equipment? Yes No
4.13 Have the cleaning procedures been validated? Yes No
4.14 Is any manufacturing equipment software-controlled? Yes No
If Yes, is this software:
Validated? Yes No
Subject to change control procedures? Yes No
If you answered No to any questions of Section 4, please provide the space below to provide additional
information:

5. BULK MANUFACTURING COMPONENTS AND MATERIALS

5.1 Are incoming bulk manufacturing materials inspected, sampled and tested
Yes No
according to written procedures?
5.2 Do you have written specifications for all incoming manufacturing materials, Yes No
including cleaning agents for manufacturing equipment and premises?
5.3 Do you routinely test incoming manufacturing materials to verify
Yes No
conformance with the supplier certification or quality claims?
5.4 Are suspect or rejected materials identified and controlled under a Yes No
quarantine system designed to prevent their use until a final decision is
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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made on their suitability?

5.5 Do you have an established supplier qualification program? Yes No
5.6 Are storage conditions and expiry dates defined for all manufacturing Yes No
materials, components and supplies?
If you answered No to any questions of Section 5, please use the space below to provide additional
information:

6 . MANUFACTURING SET-UP
6.1 Do you manufacture each batch according to pre-approved manufacturing
Yes No
procedures/instructions (e.g., Master Batch Record)?
6.2 Does each batch manufacturing record contain complete details of:
Description, batch numbers and quantities of materials used? Yes No
Samples of labelling used? Yes No
Date of manufacturing? Yes No
Equipment used? Yes No
Equipment settings? Yes No
Names of operators? Yes No
Details and results of in-process tests? Yes No
Deviations and changes that have occurred? Yes No
Cleaning operations performed before and after manufacturing? Yes No
6.3 Please describe the changeover and cleaning procedures briefly:

6.4 Is only one product batch processed in a manufacturing room/area at any Yes No
given time?
6.5 Are all deliveries of API and manufacturing components checked and verified
for their correctness against the approved Master Batch Record of other Yes No
specific order?
6.6 Before a manufacturing operation starts in a work area or on a manufacturing
line is an inspection conducted to ensure:
General cleanliness of the line and the immediate area? Yes No
Removal of all previous drug product, drug product residue,
Yes No
and packing and labelling materials?
Current calibration of all equipment/instruments? Yes No
Equipment on a Preventive Maintenance Schedule? Yes No
If these inspections are performed, who performs them?
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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If you answered No to any questions of Section 6, please use the space below to provide additional
information:

7. MANUFACTURING OPERATION PRACTICES

7.1 Is each line identified with product identifier or code and batch number? Yes No
7.2 Are there procedures describing:
The verification of the correctness of the manufacturing process at the Yes No
start and throughout manufacturing operations?
Proper control to ensure correct manufacturing Yes No
raw materials and components are used?
Proper control to ensure correct printed and/or unprinted Yes No
packaging components are used?
Controls and processes to manufacture with quarantine materials? Yes No
7.3 Are there procedures for in-process control describing:
The point of sampling? Yes No
The frequency of sampling? Yes No
The number of samples taken? Yes No
The specification(s) to be checked? Yes No
The limit of acceptability for each specification? Yes No
7.4 Are the results of in-process tests and inspection recorded and included in the Yes No
executed Batch Manufacturing Record?
7.5 Are storage containers for a bulk product, partly packed product or sub-batch
labelled and marked with:
Product identity or code? Yes No
Quantity? Yes No
Batch number? Yes No
Status? Yes No
7.6 Are products filled into their final shippers or containers and awaiting labelling
and final packaging segregated and marked with the:
Product identity or code? Yes No
Batch number? Yes No
Status? Yes No
7.7 Are supplies like lubricants, adhesive, inks, cleaning fluids etc. kept in
containers:
Different from those used for drug? Yes No
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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Clearly labelled as to their contents? Yes No

7.8 Please describe your process validation practices briefly:

If you answered No to any of the questions of Section7, please use the space below to provide additional
information:

8. COMPLETION OF MANUFACTURING OPERATIONS

8.1 Is the last production unit carefully checked to confirm with specification on Yes No
completion of the manufacturing operation?
8.2 Are only finished products from a single manufacturing operation placed on a Yes No
pallet?
8.3 For partially filled cartons, is the quantity of contents indicated accordingly? Yes No
8.4 Is inspection performed on each line or work area after the manufacturing
operations to ensure that all of the following are removed:
Excess manufacturing and packaging components? Yes No
Remaining bulk drug? Yes No
Rejected production units? Yes No
Batch documentation, instructions and records? Yes No
8.5 Are only properly identified manufacturing components and bulk products Yes No
permitted to be returned to the ware house?
8.6 Are all coded materials that are rejected or are in excess:
Counted? Yes No
Destroyed under control of the supervisor? Yes No
Recorded, including their quantity, in the Batch Record? Yes No
8.7 Are all components and bulk product reconciled under close supervision? Yes No
8.8 Are the net quantities of materials and components used for the batch Yes No
recorded in the Batch Manufacturing Record and the yields compared with
expectation?
8.9 If any significant unexplainable yield discrepancy or failure to comply with
specification is observed:

Is a thorough investigation performed and documented? Yes No

Is an investigation extended to other batches or products Yes No
which also might be affected?
Batch number? Yes No
Status? Yes No
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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8.10 Who reviews and approves manufacturing records (executed

Batch Records) after completion of manufacturing?
8.11 How long do you keep these records?
If you answered No to any questions of Section 8, please use the space below to provide additional
information:

9. QUALITY CONTROL
9.1 Is the Quality Control (QC) function independent of production? Yes No
9.2 Please describe the tests the QC laboratories are capable of performing:

9.3 Are there written plans and procedures for sampling? Yes No
9.4 Which sampling plans/systems do you use for:
Raw materials?
Finished goods?
9.5 Do you retain a sample of each batch? Yes No
If Yes, for how long?
9.6 Are there formal written procedures for all tests performed? Yes No
9.7 Do you use validated analytical methods? Yes No
9.8 Is there a written procedure to establish and manage analytical reference
Yes No
standards?
9.9 Are analytical calculations checked by a second person? Yes No
9.10 Do you perform trend analysis on analytical results? Yes No
9.11 Do you have a written procedure for documenting and investigating
Yes No
out-of-specification results?
9.12 How long do you keep analytical testing records?
9.13 Is critical analytical laboratory equipment fully qualified? Yes No
9.14 Is there are maintenance plan/procedure for this equipment? Yes No
9.15 Do you have a calibration scheme for this equipment? Yes No
9.16 Does each analytical instrument have a log book? Yes No
9.17 Does any laboratory equipment have software for control, or data capture
Yes No
and storage?
If Yes, is this software:
Validated? Yes No
Subject to change control procedures? Yes No
If you answered No to any questions of Section 9, please use the space below to provide additional
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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information:

10. QUALITY ASSURANCE

10.1 Is the Quality Assurance (QA) function independent of production? Yes No
10.2 Who is responsible for evaluation and approval of:
Specifications for components, in-process, and finished goods specifications?
Critical manufacturing process parameters?
10.3 Do you have written procedures covering the release or rejection of material? Yes No
10.4 Who is responsible for the release or rejection of finished goods? If a
Qualified Person (EU), please give the name(s).
10.5 Are deviations and non-conformances investigated, assessed and filed? Yes No
10.6 Do you conduct monitoring and periodic reviews of quality? Yes No
If Yes, what is the frequency?
10.7 Does the QA function conduct internal audits? Yes No
If Yes, please describe their scope and frequency:
10.8 Do you have a written complaints handling procedure? Yes No
10.9 Do you have a written product recall procedure? Yes No
If Yes, briefly describe your product recall procedure:

10.10 Describe how senior management and, if applicable the Qualified Person (EU) is informed of quality
related issues:

10.11 Do you have a written change control policy or procedure? Yes No

If Yes, please describe:
How you evaluate quality risks before implementing changes?
How DNDi will be notified of and approve changes?
10.12 Are any key activities critical to cGMP compliance outsourced
to third party providers, if yes please list
10.13 Do you supply a certificate of analysis with each batch? Yes No
10.14 Do you supply certification of BSE/TSE conformance for each Yes No
batch?
10.15 Do you supply a certificate of GMP conformance with each Yes No
batch?
If you answered No to any questions of Section10, please use the space below to provide additional
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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information:

11. DISTRIBUTION
11.1 Do you have systems/procedures for:
Selection of shipping packaging? Yes No
Selection of contract carriers/distributors? Yes No
Transport of temperature-sensitive goods? Yes No
Security of shipments? Yes No
Tracking and authentication of shipments? Yes No
11.2 Does each shipping container bear a label identifying contents, supplier
Yes No
name, batch number, storage conditions and re-test/expiration date?
11.3 Are container labels reconciled and the number of labels printed, used and
Yes No
destroyed recorded?
11.4 Do you keep records of all shipments to customers, including batch number
Yes No
and quantity?
If you answered No to any questions of Section11, please use the space below to provide additional
information:

12. DATA INTEGRITY

12.1 Do you have an approved data integrity policy? Yes No
If Yes, please provide the reference and effective date of the policy:

12.2 Does your data integrity policy follow the principles of “ALCOA”?
Yes No
(Attributable, Legible, Contemporaneous, Original or true copy, Accurate)
12.3 Does your data integrity policy also apply to all metadata necessary to
Yes No
reconstruct a record of GMP activities?
12.4 Is access to data systems restricted to authorised persons? Yes No
12.5 Please describe measures taken to ensure data is secured from alteration, inadvertent erasure,
deterioration or loss:

12.6 Do you perform back-up of all data? Yes No

If Yes, please provide the frequency of data back-up:

12.7 Are audit trails available to track creation, modification or deletion of data by Yes No
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Supplier Evaluation: Drug Product
Manufacturing (IMP) Quality Questionnaire
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operators (such as processing parameters and results)?

12.8 Are audit trails available to track actions at the record or system level (such as
attempts to access the system, rename or delete a file, change process Yes No
parameters or limits)?
12.9 Are data systems periodically reviewed to confirm that they remain in a valid
Yes No
and compliant state?
If Yes, please provide the frequency of review:

If you answered No to any of the questions above, please use the space below to provide additional
information:

QUESTIONNAIRE COMPLETED BY:

TITLE:

SIGNATURE & DATE: