Supplier Evaluation: Drug Product Manufacturing (IMP) Quality Questionnaire
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INSTRUCTIONS
- Please complete this questionnaire electronically.
- Use the and keys or your mouse to navigate around the form
- Click the grey-shaded fields to enter the required information.
- Click the grey-shaded boxes to check or uncheck .
- Print the completed form, then sign and date.
- 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 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 with training requirements? / Yes / No
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
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), pleaseuse 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
inventory system that doesn’t require separation) / Yes / No
Approved finished goods? (This may be controlled by an
inventory system that doesn’t require separation) / 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 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 crosscontamination:
4.5 / Do your areas for manufacturing, testing and storage have:
Written cleaning or house-keeping procedures? / Yes / No
Environmental controls and monitoring program
(e.g. temperature, humidity, microbial)? / Yes / No
A pest control program? / Yes / No
Security/access control measures? / Yes / No
If you answered Yes to any questions of Section 4.5,
are records for these available? / Yes / No
4.6 / Has full qualification (IQ, OQ, PQ) of all utilities (e.g., HVAC, purified water, WFI, compressed air, clean steam) that support manufacturing operations, including equipment cleaning, been completed and documented? / Yes / No
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 equipment? / Yes / No
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 according to written procedures? / Yes / No
5.2 / Do you have written specifications for all incoming manufacturing materials, including cleaning agents for manufacturing equipment and premises? / Yes / No
5.3 / Do you routinely test incoming manufacturing materials to verify conformance with the supplier certification or quality claims? / Yes / No
5.4 / Are suspect or rejected materials identified and controlled under a quarantine system designed to prevent their use until a final decision is made on their suitability? / Yes / No
5.5 / Do you have an established supplier qualification program? / Yes / No
5.6 / Are storage conditions and expiry dates defined for all manufacturing materials, components and supplies? / Yes / No
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 procedures/instructions (e.g., Master Batch Record)? / Yes / No
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 given time? / Yes / No
6.5 / Are all deliveries of API and manufacturing components checked and verified for their correctness against the approved Master Batch Record of other specific order? / Yes / No
6.6 / Before a manufacturing operation starts in a work area or on a manufacturing line is an inspection conducted to ensure:
General cleanlinessof the line and the immediate area? / Yes / No
Removal of all previous drug product, drug product residue,
and packing andlabelling materials? / Yes / No
Current calibration of all equipment/instruments? / Yes / No
Equipment on a Preventive Maintenance Schedule? / Yes / No
If these inspections are performed, who performs them?
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 codeand batch number? / Yes / No
7.2 / Are there procedures describing:
The verification of the correctness of the manufacturing process at the
start and throughout manufacturing operations? / Yes / No
Proper control to ensure correct manufacturing
raw materials and components are used? / Yes / No
Proper control to ensure correct printed and/or unprinted
packaging components are used? / Yes / No
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 executed Batch Manufacturing Record? / Yes / No
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
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 completion of the manufacturing operation? / Yes / No
8.2 / Are only finished products from a single manufacturing operation placed on a pallet? / Yes / No
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 permitted to be returned to the ware house? / Yes / No
8.6 / Are all codedmaterials 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 recorded in the Batch Manufacturing Record and the yields compared with expectation? / Yes / No
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
which also might be affected? / Yes / No
Batch number? / Yes / No
Status? / Yes / No
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 standards? / Yes / No
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 outofspecification results? / Yes / No
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 and storage? / 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 9, 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 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?
HowDNDiwill 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 batch? / Yes / No
10.15 / Do you supply a certificate of GMP conformance with each batch? / Yes / No
If you answered No to any questions of Section10, 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 name, batch number, storage conditions and re-test/expiration date? / Yes / No
11.3 / Are container labels reconciled and the number of labels printed, used and destroyed recorded? / Yes / No
11.4 / Do you keep records of all shipments to customers, including batch number and quantity? / Yes / No
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”?
(Attributable, Legible, Contemporaneous, Original or true copy, Accurate) / Yes / No
12.3 / Does your data integrity policy also apply to all metadata necessary to reconstruct a record of GMP activities? / Yes / No
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 operators (such as processing parameters and results)? / Yes / No
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 parameters or limits)? / Yes / No
12.9 / Are data systems periodically reviewed to confirm that they remain in a valid and compliant state? / Yes / No
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:
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