Professional Documents
Culture Documents
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:
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
CONFIDENTIAL
Supplier Evaluation: IMP Packaging
Quality Questionnaire
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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):
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:
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:
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:
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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Supplier Evaluation: IMP Packaging
Quality Questionnaire
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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:
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:
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:
12.2 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:
13.2 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:
13.7 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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Supplier Evaluation: IMP Packaging
Quality Questionnaire
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If you answered No to any of the questions above, please use the space below to provide additional
information:
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