CONFIDENTIAL

Supplier Evaluation: IMP Packaging

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 packaging

premises:

1.4 Types of packaging

operations performed (e.g.,
labelling only; filling of
bottles, blisters, ampoules,
sachets, syringes):

1.5 Dosage forms packaged

(e.g., liquids, tablets,
sprinkles, gels, creams,
capsules):
1.6 Capability to supply tamper-
evident packaging:

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
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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 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 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
Hygiene? Yes No
Cleanliness? Yes No
Health and safety? Yes No
3.5 Please describe how the competency of staff is evaluated:

If you answered No to any of the questions above, 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 packaging components and materials? Yes No
Preparation and control of labelling materials? Yes No
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Packaging? Yes No
Quarantined finished goods? Yes No
Approved finished goods? Yes No
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 packaged 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 of the above, please describe specific measures taken to prevent
cross-contamination:

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

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 of the above, are records for these available? Yes No
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 packaging operations,
including equipment cleaning, been completed and documented?
4.7 Do you monitor the conformance of all utilities to their quality standards? Yes No
4.8 Are plant utilities pipelines clearly identified and labelled? Yes No
4.9 Is there a maintenance/preventative maintenance program for all equipment? Yes No
4.10 Do you have written maintenance and calibration procedures for critical
Yes No
equipment?
4.11 Is there a written cleaning plan/procedure for all equipment? Yes No
4.12 Have the cleaning procedures been validated? Yes No
4.13 Is any packaging equipment software-controlled? Yes No
If Yes, is this software:
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Validated? Yes No
Subject to change control procedures? Yes No
If you answered No to any of the questions above, please provide the space below to provide additional
information:

5.BULK PACKAGING COMPONENTS AND MATERIALS

5.1 Are incoming bulk packaging materials inspected, sampled and tested
Yes No
according to written procedures?
5.2 Do you have written specifications for all incoming packaging materials, Yes No
including cleaning agents for packaging equipment and premises?
5.3 Do you routinely test incoming packaging materials to verify conformance
Yes No
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
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 packaging materials? Yes No
If you answered No to any of the questions above, please use the space below to provide additional
information:

6 .PACKAGING SET-UP
6.1 Do you package each batch according to pre-approved packaging
Yes No
procedures/instructions?
6.2 Does each batch packaging record contain complete details of:
Description, batch numbers and quantities of materials used? Yes No
Samples of labelling used? Yes No
Date of packaging? 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 packaging? Yes No
6.3 Who reviews and approves these records after manufacture?
6.4 How long do you keep these records?
6.5 Is only one product batch and packaging size on a line at any given time? Yes No
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6.6 Are all deliveries of bulk product and packaging components checked and
verified for their correctness against the Master Packaging Procedure or other Yes No
specific order?
6.7 Does pre-coding of components take place in an area isolated from other Yes No
packaging operations?
6.8 Are components allocated for pre-coding stored in sealed containers within an Yes No
appropriate area for proper security and segregation?
6.9 Are all pre-coded components checked against the correctness before transfer Yes No
to the packaging line?
6.10 Before a packaging operation starts in a work area or on a packaging 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, and labelling
Yes No
materials?
If these inspections are performed, who performs them?
If you answered No to any of the questions above, please use the space below to provide additional
information:

7. PACKAGING OPERATION PRACTICES

7.1 Is each packaging line identified with product name, pack, size, and batch Yes No
number?
7.2 Are there procedures describing:
Proper control to ensure correct printed and unprinted Yes No
packaging components are used?
Verification of correctness of labelling at the Yes No
beginning of and throughout operations?
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
Batch Packaging Record?
7.5 Are storage containers for a bulk product, partly packed product or sub-batch
labelled and marked with:
Product identity? Yes No
Quantity? Yes No
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Batch number? Yes No

Status? Yes No
7.6 Are finished or semi-finished packages observed off the packaging line:
Given to the supervisor of packaging? Yes No
Never returned directly to the packaging line? Yes No
Destroyed under supervision and the quantity recorded Yes No
if they cannot be confirmed as the same batch?
7.7 Are products filled into their final containers and awaiting labelling and final
packaging segregated and marked with the:
Product identity? Yes No
Batch number? Yes No
Status? Yes No
7.8 Are measures taken to control the spread of dust during packaging,
especially of dry products, by:
Cleaning components and transfer containers before
Yes No
bringing them to the packaging station or line?
Using dust collection devices? Yes No
Discouraging the use of brushes? Yes No
Discouraging the use of compressed air? Yes No
7.9 Are supplies like lubricants, adhesive, inks, cleaning fluids etc. kept in
containers:
Different from those used for drug? Yes No
Clearly labelled as to their contents? Yes No
7.10 Is bringing personal medications into the packaging area strictly prohibited? Yes No
7.11 Are pockets prohibited on uniforms or clothing worn in the packaging area? Yes No
If you answered No to any of the questions above, please use the space below to provide additional
information:

8. COMPLETION OF PACKAGING OPERATIONS

8.1 Is the last production package carefully checked to confirm with specification Yes No
on completion of the packaging operation?
8.2 Are only finished products from a single packaging 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 after the packaging operations, to ensure
that all of the following are removed:
Excess packaging components? Yes No
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Remaining bulk drug? Yes No

Rejected packaging components? Yes No
Batch documentation, instructions and records? Yes No
8.5 Are only properly identified packaging components and bulk products Yes No
permitted to be returned to the ware house?
Are all coded packaging 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 Packaging Record? Yes No
8.6 Are all components and bulk product reconciled under close supervision? Yes No
8.7 Are the net quantities of components used for the batch recorded in the Yes No
Batch Packaging Record?
8.8 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 which also might be Yes No
affected?
If you answered No to any of the questions above, 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 Do you use any contract QC laboratories? Yes No

If Yes:
Have you evaluated/qualified these laboratories? Yes No
Please list the types of testing contracted to these laboratories:
9.4 Are there written plans and procedures for sampling? Yes No
9.5 Which sampling plans/systems do you use for:
Packaging materials?
Bulk products?
Finished goods?
9.6 Do you retain a sample of each batch? Yes No
If Yes, for how long?
9.7 Are there formal written procedures for all tests performed? Yes No
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9.8 Do you use validated analytical methods for QC testing? Yes No

9.9 Is there a written procedure to establish and manage analytical reference
Yes No
standards?
9.10 Are analytical calculations checked by a second person? Yes No
9.11 Do you perform trend analysis on analytical results? Yes No
9.12 Do you have a written procedure for documenting and investigating
Yes No
out-of-specification results?
9.13 How long do you keep analytical testing records?
9.14 Is critical analytical laboratory equipment fully qualified? Yes No
9.15 Is there are maintenance plan/procedure for this equipment? Yes No
9.16 Do you have a calibration scheme for this equipment? Yes No
9.17 Does each analytical instrument have a log book? Yes No
9.18 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 of the questions above, please use the space below to provide additional
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 packaging 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?
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:
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10.10 Describe how senior management 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
Describe how DNDi will be notified and approve changes
10.12 Do you supply a certificate of GMP conformance with each batch? Yes No
If you answered No to any of the questions above, please use the space below to provide additional
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?
11.5 Do you use re-usable containers? Yes No
If Yes, are they cleaned via validated procedures and inspected
Yes No
before re-use?
If you answered No to any of the questions above, please use the space below to provide additional
information:

12. Investigational Medicinal Products

12.1 Do you have systems/procedures for the sourcing of Comparative Agents? Yes No
If yes, are Comparative Agents supplied by approved vendors? Yes No
Do you assure Comparative Agents are not counterfeit? Yes No
Do you have systems in place to monitor potential recall of Comparative
Yes No
Agents used in clinical studies?
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12.2 Do you have systems/procedures for the blinding of clinical studies? Yes No
If yes, do you have controls for the generation or importation of
Yes No
randomisation codes?
Do you prepare Patient Information Disclosure Sheets? Yes No
12.3 Do you utilise telerandomisation techniques? Yes No
If yes, is the system fully validated? Yes No
12.4 Do you have systems/procedures in place for the generation of multi-
Yes No
language label and translations?
If yes, is the system fully validated? Yes No
12.5 Do you hold an IMP Manufacturers licence (EU) or equivalent (non-EU)? Yes No
If so, please provide copy.
12.6 Do you have systems/procedures in place for the QP certification of IMPs
Yes No
(EU) or equivalent (non-EU)?
If you answered No to any of the questions above, please use the space below to provide additional
information:

13. DATA INTEGRITY

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

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

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

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

13.7 Are audit trails available to track creation, modification or deletion of data by
Yes No
operators (such as processing parameters and results)?
13.8 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)?
13.9 Are data systems periodically reviewed to confirm that they remain in a valid Yes No
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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: