DP (IMP) Quality Questionnaire



INSTRUCTIONSPlease complete this questionnaire electronically.Use the and keys or your mouse to navigate around the formClick 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 INFORMATION1.1Supplier name: FORMTEXT ?????1.2Corporate address: FORMTEXT ?????1.3Address of manufacturing premises: FORMTEXT ?????1.4Types of manufacturing operations performed: FORMTEXT ?????1.5Non-sterile Dosage forms manufactured (e.g., tablets, capsules, semi-solids etc): FORMTEXT ?????Sterile Dosage forms manufactured (e.g. vials, ampoules, lyophiles etc) FORMTEXT ?????1.6Scale(s) of manufacturing of different dosage forms: FORMTEXT ?????1.7Phases of Clinical Manufacturing Experience (I-IV) FORMTEXT ?????1.8Storage Capabilities (CRT, 2-8C, -20C, -70C) FORMTEXT ?????1.9 Capability to manufacture blinded drugs/placebos (including procedures assuring neither mix-ups nor presence of potential blind-breaking characteristics): FORMTEXT ?????2. GENERAL INFORMATION2.1What types of materials do you package, manufacture or handle at the premises?Pharmaceuticals? FORMCHECKBOX Yes FORMCHECKBOX NoAgricultural chemicals? FORMCHECKBOX Yes FORMCHECKBOX NoGeneral chemicals? FORMCHECKBOX Yes FORMCHECKBOX NoFood ingredients? FORMCHECKBOX Yes FORMCHECKBOX NoOther (please specify): FORMTEXT ?????2.2Do you follow current Good Manufacturing Practices (cGMP) at the premises? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please list which cGMP standards you follow: FORMTEXT ?????2.3Are the premises inspected by national or international health authorities? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please list recent inspection history (health authority, date of inspection and outcomes): FORMTEXT ?????2.4Are the premises subject to any regulatory warning or enforcement actions? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please describe these below: FORMTEXT ?????2.5Please list any additional quality accreditations (e.g. ISO 9001): FORMTEXT ?????PLEASE PROVIDE COPIES OF SUPPORTING DOCUMENTATION, CERTIFICATES ETC.3. PERSONNEL3.1Do you have written job descriptions for all personnel? FORMCHECKBOX Yes FORMCHECKBOX No3.2Do you have a written training policy or procedure? FORMCHECKBOX Yes FORMCHECKBOX No3.3Do you maintain training records for all staff? FORMCHECKBOX Yes FORMCHECKBOX No3.4Do you have a system or process to readily identify the level of compliance with training requirements? FORMCHECKBOX Yes FORMCHECKBOX No3.5Does the training program include:cGMP regulations and updates? FORMCHECKBOX Yes FORMCHECKBOX NoQuality systems? FORMCHECKBOX Yes FORMCHECKBOX NoContinuous improvement techniques? FORMCHECKBOX Yes FORMCHECKBOX NoJob specific training? FORMCHECKBOX Yes FORMCHECKBOX NoPeriodic refresher training? FORMCHECKBOX Yes FORMCHECKBOX NoHygiene? FORMCHECKBOX Yes FORMCHECKBOX NoCleanliness? FORMCHECKBOX Yes FORMCHECKBOX NoHealth and safety? FORMCHECKBOX Yes FORMCHECKBOX No3.6Please describe how the competency of staff is evaluated: FORMTEXT ?????If you answered No to any of the questions of Section3 (Personnel), please use the space below to provide additional information: FORMTEXT ?????4. PREMISES, UTILITIES AND EQUIPMENT4.1Were the premises designed for their present use? FORMCHECKBOX Yes FORMCHECKBOX No4.2Are there separate areas for:Receipt of bulk manufacturing components and materials? FORMCHECKBOX Yes FORMCHECKBOX NoPreparation and control of labelling materials? FORMCHECKBOX Yes FORMCHECKBOX NoManufacturing? FORMCHECKBOX Yes FORMCHECKBOX NoQuarantined finished goods? (This may be controlled by an inventory system that doesn’t require separation) FORMCHECKBOX Yes FORMCHECKBOX NoApproved finished goods? (This may be controlled by an inventory system that doesn’t require separation) FORMCHECKBOX Yes FORMCHECKBOX NoRest and eating? FORMCHECKBOX Yes FORMCHECKBOX No4.3Does the present design prevent:Chemical contamination? FORMCHECKBOX Yes FORMCHECKBOX NoPhysical contamination? FORMCHECKBOX Yes FORMCHECKBOX NoMicrobial contamination? FORMCHECKBOX Yes FORMCHECKBOX No4.4Are any of the following materials handled or manufactured in the premises:Beta-lactams (cephalosporins, penicillins)? FORMCHECKBOX Yes FORMCHECKBOX NoHormones? FORMCHECKBOX Yes FORMCHECKBOX NoCytotoxic, genotoxic? FORMCHECKBOX Yes FORMCHECKBOX NoPesticides, herbicides? FORMCHECKBOX Yes FORMCHECKBOX NoBiological or GMO preparations? FORMCHECKBOX Yes FORMCHECKBOX NoHighly potent/toxic products? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered Yes to any questions of Section 4.4, please describe specific measures taken to prevent crosscontamination: FORMTEXT ?????4.5Do your areas for manufacturing, testing and storage have: Written cleaning or house-keeping procedures? FORMCHECKBOX Yes FORMCHECKBOX NoEnvironmental controls and monitoring program(e.g. temperature, humidity, microbial)? FORMCHECKBOX Yes FORMCHECKBOX NoA pest control program? FORMCHECKBOX Yes FORMCHECKBOX NoSecurity/access control measures? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered Yes to any questions of Section 4.5, are records for these available? FORMCHECKBOX Yes FORMCHECKBOX No4.6Has 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? FORMCHECKBOX Yes FORMCHECKBOX No4.7Is all equipment qualified? FORMCHECKBOX Yes FORMCHECKBOX No4.8Do you monitor the conformance of all utilities to their quality standards? FORMCHECKBOX Yes FORMCHECKBOX No4.9Are plant utilities pipelines clearly identified and labelled? FORMCHECKBOX Yes FORMCHECKBOX No4.10Is there a maintenance/preventative maintenance program for all equipment? FORMCHECKBOX Yes FORMCHECKBOX No4.11Do you have written maintenance and calibration procedures for critical equipment? FORMCHECKBOX Yes FORMCHECKBOX No4.12Is there a written cleaning plan/procedure for all equipment? FORMCHECKBOX Yes FORMCHECKBOX No4.13Have the cleaning procedures been validated? FORMCHECKBOX Yes FORMCHECKBOX No4.14Is any manufacturing equipment software-controlled? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, is this software:Validated? FORMCHECKBOX Yes FORMCHECKBOX NoSubject to change control procedures? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered No to any questions of Section 4, please provide the space below to provide additional information: FORMTEXT ?????5. BULK MANUFACTURING COMPONENTS AND MATERIALS5.1Are incoming bulk manufacturing materials inspected, sampled and tested according to written procedures? FORMCHECKBOX Yes FORMCHECKBOX No5.2Do you have written specifications for all incoming manufacturing materials, including cleaning agents for manufacturing equipment and premises? FORMCHECKBOX Yes FORMCHECKBOX No5.3Do you routinely test incoming manufacturing materials to verify conformance with the supplier certification or quality claims? FORMCHECKBOX Yes FORMCHECKBOX No5.4Are 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? FORMCHECKBOX Yes FORMCHECKBOX No5.5Do you have an established supplier qualification program? FORMCHECKBOX Yes FORMCHECKBOX No5.6Are storage conditions and expiry dates defined for all manufacturing materials, components and supplies? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered No to any questions of Section 5, please use the space below to provide additional information: FORMTEXT ?????6 . MANUFACTURING SET-UP6.1Do you manufacture each batch according to pre-approved manufacturing procedures/instructions (e.g., Master Batch Record)? FORMCHECKBOX Yes FORMCHECKBOX No6.2Does each batch manufacturing record contain complete details of:Description, batch numbers and quantities of materials used? FORMCHECKBOX Yes FORMCHECKBOX NoSamples of labelling used? FORMCHECKBOX Yes FORMCHECKBOX NoDate of manufacturing? FORMCHECKBOX Yes FORMCHECKBOX NoEquipment used? FORMCHECKBOX Yes FORMCHECKBOX NoEquipment settings? FORMCHECKBOX Yes FORMCHECKBOX NoNames of operators? FORMCHECKBOX Yes FORMCHECKBOX NoDetails and results of in-process tests? FORMCHECKBOX Yes FORMCHECKBOX NoDeviations and changes that have occurred? FORMCHECKBOX Yes FORMCHECKBOX NoCleaning operations performed before and after manufacturing? FORMCHECKBOX Yes FORMCHECKBOX No6.3Please describe the changeover and cleaning procedures briefly: FORMTEXT ?????6.4Is only one product batch processed in a manufacturing room/area at any given time? FORMCHECKBOX Yes FORMCHECKBOX No6.5Are all deliveries of API and manufacturing components checked and verified for their correctness against the approved Master Batch Record of other specific order? FORMCHECKBOX Yes FORMCHECKBOX No6.6Before 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? FORMCHECKBOX Yes FORMCHECKBOX NoRemoval of all previous drug product, drug product residue, and packing and labelling materials? FORMCHECKBOX Yes FORMCHECKBOX NoCurrent calibration of all equipment/instruments? FORMCHECKBOX Yes FORMCHECKBOX NoEquipment on a Preventive Maintenance Schedule? FORMCHECKBOX Yes FORMCHECKBOX NoIf these inspections are performed, who performs them? FORMTEXT ?????If you answered No to any questions of Section 6, please use the space below to provide additional information: FORMTEXT ?????7. MANUFACTURING OPERATION PRACTICES7.1Is each line identified with product identifier or code and batch number? FORMCHECKBOX Yes FORMCHECKBOX No7.2Are there procedures describing:The verification of the correctness of the manufacturing process at the start and throughout manufacturing operations? FORMCHECKBOX Yes FORMCHECKBOX NoProper control to ensure correct manufacturing raw materials and components are used? FORMCHECKBOX Yes FORMCHECKBOX NoProper control to ensure correct printed and/or unprinted packaging components are used? FORMCHECKBOX Yes FORMCHECKBOX NoControls and processes to manufacture with quarantine materials? FORMCHECKBOX Yes FORMCHECKBOX No7.3Are there procedures for in-process control describing:The point of sampling? FORMCHECKBOX Yes FORMCHECKBOX NoThe frequency of sampling? FORMCHECKBOX Yes FORMCHECKBOX NoThe number of samples taken? FORMCHECKBOX Yes FORMCHECKBOX NoThe specification(s) to be checked? FORMCHECKBOX Yes FORMCHECKBOX NoThe limit of acceptability for each specification? FORMCHECKBOX Yes FORMCHECKBOX No7.4Are the results of in-process tests and inspection recorded and included in the executed Batch Manufacturing Record? FORMCHECKBOX Yes FORMCHECKBOX No7.5Are storage containers for a bulk product, partly packed product or sub-batch labelled and marked with:Product identity or code? FORMCHECKBOX Yes FORMCHECKBOX NoQuantity? FORMCHECKBOX Yes FORMCHECKBOX NoBatch number? FORMCHECKBOX Yes FORMCHECKBOX NoStatus? FORMCHECKBOX Yes FORMCHECKBOX No7.6Are products filled into their final shippers or containers and awaiting labelling and final packaging segregated and marked with the:Product identity or code? FORMCHECKBOX Yes FORMCHECKBOX NoBatch number? FORMCHECKBOX Yes FORMCHECKBOX NoStatus? FORMCHECKBOX Yes FORMCHECKBOX No7.7Are supplies like lubricants, adhesive, inks, cleaning fluids etc. kept in containers:Different from those used for drug? FORMCHECKBOX Yes FORMCHECKBOX NoClearly labelled as to their contents? FORMCHECKBOX Yes FORMCHECKBOX No7.8Please describe your process validation practices briefly: FORMTEXT ?????If you answered No to any of the questions of Section7, please use the space below to provide additional information: FORMTEXT ?????8. COMPLETION OF MANUFACTURING OPERATIONS8.1Is the last production unit carefully checked to confirm with specification on completion of the manufacturing operation? FORMCHECKBOX Yes FORMCHECKBOX No8.2Are only finished products from a single manufacturing operation placed on a pallet? FORMCHECKBOX Yes FORMCHECKBOX No8.3For partially filled cartons, is the quantity of contents indicated accordingly? FORMCHECKBOX Yes FORMCHECKBOX No8.4Is 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? FORMCHECKBOX Yes FORMCHECKBOX NoRemaining bulk drug? FORMCHECKBOX Yes FORMCHECKBOX NoRejected production units? FORMCHECKBOX Yes FORMCHECKBOX NoBatch documentation, instructions and records? FORMCHECKBOX Yes FORMCHECKBOX No8.5Are only properly identified manufacturing components and bulk products permitted to be returned to the ware house? FORMCHECKBOX Yes FORMCHECKBOX No 8.6Are all coded materials that are rejected or are in excess: Counted? FORMCHECKBOX Yes FORMCHECKBOX NoDestroyed under control of the supervisor? FORMCHECKBOX Yes FORMCHECKBOX NoRecorded, including their quantity, in the Batch Record? FORMCHECKBOX Yes FORMCHECKBOX No8.7Are all components and bulk product reconciled under close supervision? FORMCHECKBOX Yes FORMCHECKBOX No8.8Are the net quantities of materials and components used for the batch recorded in the Batch Manufacturing Record and the yields compared with expectation? FORMCHECKBOX Yes FORMCHECKBOX No8.9If any significant unexplainable yield discrepancy or failure to comply with specification is observed:Is a thorough investigation performed and documented? FORMCHECKBOX Yes FORMCHECKBOX NoIs an investigation extended to other batches or products which also might be affected? FORMCHECKBOX Yes FORMCHECKBOX NoBatch number? FORMCHECKBOX Yes FORMCHECKBOX NoStatus? FORMCHECKBOX Yes FORMCHECKBOX No8.10Who reviews and approves manufacturing records (executed Batch Records) after completion of manufacturing? FORMTEXT ?????8.11How long do you keep these records? FORMTEXT ?????If you answered No to any questions of Section 8, please use the space below to provide additional information: FORMTEXT ?????9. QUALITY CONTROL9.1Is the Quality Control (QC) function independent of production? FORMCHECKBOX Yes FORMCHECKBOX No9.2Please describe the tests the QC laboratories are capable of performing: FORMTEXT ?????9.3Are there written plans and procedures for sampling? FORMCHECKBOX Yes FORMCHECKBOX No9.4Which sampling plans/systems do you use for:Raw materials? FORMTEXT ?????Finished goods? FORMTEXT ?????9.5Do you retain a sample of each batch? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, for how long? FORMTEXT ?????9.6Are there formal written procedures for all tests performed? FORMCHECKBOX Yes FORMCHECKBOX No9.7Do you use validated analytical methods? FORMCHECKBOX Yes FORMCHECKBOX No9.8Is there a written procedure to establish and manage analytical reference standards? FORMCHECKBOX Yes FORMCHECKBOX No9.9Are analytical calculations checked by a second person? FORMCHECKBOX Yes FORMCHECKBOX No9.10Do you perform trend analysis on analytical results? FORMCHECKBOX Yes FORMCHECKBOX No9.11Do you have a written procedure for documenting and investigating outofspecification results? FORMCHECKBOX Yes FORMCHECKBOX No9.12How long do you keep analytical testing records? FORMTEXT ?????9.13Is critical analytical laboratory equipment fully qualified? FORMCHECKBOX Yes FORMCHECKBOX No9.14Is there are maintenance plan/procedure for this equipment? FORMCHECKBOX Yes FORMCHECKBOX No9.15Do you have a calibration scheme for this equipment? FORMCHECKBOX Yes FORMCHECKBOX No9.16Does each analytical instrument have a log book? FORMCHECKBOX Yes FORMCHECKBOX No9.17Does any laboratory equipment have software for control, or data capture and storage? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, is this software:Validated? FORMCHECKBOX Yes FORMCHECKBOX NoSubject to change control procedures? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered No to any questions of Section 9, please use the space below to provide additional information: FORMTEXT ?????10. QUALITY ASSURANCE10.1Is the Quality Assurance (QA) function independent of production? FORMCHECKBOX Yes FORMCHECKBOX No10.2Who is responsible for evaluation and approval of:Specifications for components, in-process, and finished goods specifications? FORMTEXT ?????Critical manufacturing process parameters? FORMTEXT ?????10.3Do you have written procedures covering the release or rejection of material? FORMCHECKBOX Yes FORMCHECKBOX No10.4Who is responsible for the release or rejection of finished goods? If a Qualified Person (EU), please give the name(s). FORMTEXT ?????10.5Are deviations and non-conformances investigated, assessed and filed? FORMCHECKBOX Yes FORMCHECKBOX No10.6Do you conduct monitoring and periodic reviews of quality? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, what is the frequency? FORMTEXT ?????10.7Does the QA function conduct internal audits? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please describe their scope and frequency: FORMTEXT ?????10.8Do you have a written complaints handling procedure? FORMCHECKBOX Yes FORMCHECKBOX No10.9Do you have a written product recall procedure? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, briefly describe your product recall procedure: FORMTEXT ?????10.10Describe how senior management and, if applicable the Qualified Person (EU) is informed of quality related issues: FORMTEXT ?????10.11Do you have a written change control policy or procedure? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please describe:How you evaluate quality risks before implementing changes? FORMTEXT ?????How DNDi will be notified of and approve changes? FORMTEXT ?????10.12Are any key activities critical to cGMP compliance outsourced to third party providers, if yes please list FORMTEXT ?????10.13Do you supply a certificate of analysis with each batch? FORMCHECKBOX Yes FORMCHECKBOX No10.14Do you supply certification of BSE/TSE conformance for each batch? FORMCHECKBOX Yes FORMCHECKBOX No10.15Do you supply a certificate of GMP conformance with each batch? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered No to any questions of Section10, please use the space below to provide additional information: FORMTEXT ?????11. DISTRIBUTION11.1Do you have systems/procedures for:Selection of shipping packaging? FORMCHECKBOX Yes FORMCHECKBOX NoSelection of contract carriers/distributors? FORMCHECKBOX Yes FORMCHECKBOX NoTransport of temperature-sensitive goods? FORMCHECKBOX Yes FORMCHECKBOX NoSecurity of shipments? FORMCHECKBOX Yes FORMCHECKBOX NoTracking and authentication of shipments? FORMCHECKBOX Yes FORMCHECKBOX No11.2Does each shipping container bear a label identifying contents, supplier name, batch number, storage conditions and re-test/expiration date? FORMCHECKBOX Yes FORMCHECKBOX No11.3Are container labels reconciled and the number of labels printed, used and destroyed recorded? FORMCHECKBOX Yes FORMCHECKBOX No11.4Do you keep records of all shipments to customers, including batch number and quantity? FORMCHECKBOX Yes FORMCHECKBOX NoIf you answered No to any questions of Section11, please use the space below to provide additional information: FORMTEXT ?????12. DATA INTEGRITY12.1Do you have an approved data integrity policy? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please provide the reference and effective date of the policy: FORMTEXT ?????12.2Does your data integrity policy follow the principles of “ALCOA”?(Attributable, Legible, Contemporaneous, Original or true copy, Accurate) FORMCHECKBOX Yes FORMCHECKBOX No12.3Does your data integrity policy also apply to all metadata necessary to reconstruct a record of GMP activities? FORMCHECKBOX Yes FORMCHECKBOX No12.4Is access to data systems restricted to authorised persons? FORMCHECKBOX Yes FORMCHECKBOX No12.5Please describe measures taken to ensure data is secured from alteration, inadvertent erasure, deterioration or loss: FORMTEXT ?????12.6Do you perform back-up of all data? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please provide the frequency of data back-up: FORMTEXT ?????12.7Are audit trails available to track creation, modification or deletion of data by operators (such as processing parameters and results)? FORMCHECKBOX Yes FORMCHECKBOX No12.8Are 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)? FORMCHECKBOX Yes FORMCHECKBOX No12.9Are data systems periodically reviewed to confirm that they remain in a valid and compliant state? FORMCHECKBOX Yes FORMCHECKBOX NoIf Yes, please provide the frequency of review: FORMTEXT ?????If you answered No to any of the questions above, please use the space below to provide additional information: FORMTEXT ?????QUESTIONNAIRE COMPLETED BY: FORMTEXT ?????TITLE: FORMTEXT ?????SIGNATURE & DATE: ................
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