Name |
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Address |
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Internet Address |
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Name of Parent Organization (if any) |
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Correspondent: Name / Title |
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Phone Number |
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Fax Number |
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E-Mail Address |
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Vendor Approval: |
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Name | Position | Date |
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1 | Company Activity | Yes | No | N/A |
1.1 | Distributor (a wholesaler who takes title to the property of the goods) |
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1.2 | Transportation ( a courier service that collects and delivers product) |
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1.3 | Broker (an agent who buys or/and sells for a principal on a commission basis without having title to the property) |
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1.4 | Other (please specify): ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………… | |||
1.5 | Percentage of your company Business in the Pharmaceutical Industry / Other main activities | ….. % ………………………… | ||
2 | Materials Handled | Yes | No | N/A |
2.1 | Active Pharmaceutical Ingredients (APIs) |
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2.2 | Excipients |
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2.3 | Fine chemicals |
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2.4 | Radioactive |
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2.5 | Flammables |
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2.6 | Controlled drugs (Schedule 1 to 5) |
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2.7 | Others (specify) …………………………………………………………………… | |||
3 | Quality System & Quality Management | Yes | No | N/A |
3.1 | Is there a quality management system implemented? |
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3.2 | Is there a third-party certification of the quality system (Covered by ISO 9001:2008 certification or other)? Please provide copies of current version |
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3.3 | Does the company hold a wholesale dealer licence or a GDP certificate of compliance? Please provide copies of current version. |
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3.4 | Does your company have a written policy including management's active commitment to Quality? |
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3.5 | Are there written standard operating procedures (SOPs) in place that describe operations to be performed by the personnel? |
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3.6 | Is there a quality manual and written procedures describing Good Distribution Practices related processes? |
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3.7 | Does the company have a written procedure on internal audits and audits of contracted services? If yes, please briefly describe the process followed: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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3.8 | Does the company operate a documented system for quarantining suspect product? |
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3.9 | Does the company have a formal system for documenting and investigating incidences that impact on the product quality? |
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3.10 | Is there a procedure for internal audits of the quality management system including an audit plan? |
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3.11 | In case of emergency does the company have a written procedure for deliveries outside normal business hours and does the company offer this service? …………………………………………………………………………………… ……………………………………………………………………………………. |
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3.12 | Is a formal management review of the Quality Management System held at least once a year? |
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3.13 | Is there a document control system in place ensuring proper design, approval, review, and distribution of necessary documentation? |
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4 | Organisation & Personnel | Yes | No | N/A |
4.1 | Has the company a sufficient number of qualified employees for these operations? |
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4.2 | Have all (including administrative) personnel, involved in handling and transporting medicinal products, been made aware of the potential risks to human health? |
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4.3 | For new personnel employed or contractors, please indicate the checks performed on the individual, in particular any security checks : …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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4.4 | Is there a specific qualification required for employees responsible for key activities in Safety, Health, Environment and Quality? If yes, please specify : …………………………………………………………. |
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4.5 | Are the health and safety responsible persons providing regular training to employees dealing with hazardous materials? |
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4.6 | Have job descriptions been made and regularly updated? |
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4.7 | Has an evaluation been made of all activities to identify training needs? |
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4.8 | Is initial and ongoing general training provided? |
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4.9 | Are employee training and qualification records maintained? |
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4.10 | Are internal and external training courses documented? (Documentation of training should include records of training effectiveness.) |
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4.11 | Are contracted service providers included in the training program? |
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4.12 | Are contractors provided with information relevant to the job to be done? |
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4.13 | Are contractors provided with appropriate training if necessary? |
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4.14 | Are contractors provided with appropriate personal protective equipment? |
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4.15 | Are there procedures in place ensuring good hygiene of the personnel where exposure to material in open containers may occur (e.g. monitoring of health conditions, wearing of protective clothes etc.)? |
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4.16 | Is there a person with the specific responsibility and the appropriate authority to deal with GDP issues in the company? |
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4.17 | Is initial and ongoing GDP training provided? Are training sessions recorded? Is there a training evaluation system? |
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5 | Transportation | Yes | No | N/A |
5.1 | Does the company have a dedicated fleet of vehicles for the transportation of medicinal products? |
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5.2 | Do the vehicles have dual temperature capabilities? |
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5.3 | If the company possesses any vehicles that have temperature controlled chambers, has any validation study been performed and documented to ensure optimal operating conditions, taking into consideration any environmental variables? |
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5.4 | Do the vehicles have temperature controlling, monitoring and reporting devices? |
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5.5 | If yes to 5.4, are these devices serviced and calibrated?
Please specify frequency of maintenance and calibration: …………………………………………………………………………………… …………………………………………………………………………………… |
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5.6 | Are the vehicles locations tracked via GPS? |
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5.7 | Are transportation vehicles cleaned on a frequent basis and are records available to view on request? Please specify frequency of cleaning and any additional information: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………….. |
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5.8 | Are transportation vehicles serviced on a frequent basis and are records available to view on request? Please specify frequency of servicing and any additional information: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………….. |
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5.9 | Are Transportation/distribution records kept for each shipment? Please specify the records that are retained and the archive period for these records: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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5.10 | Is there a written procedure detailing the process to be followed in the event of an unexpected occurrence such as vehicle breakdown (engine or storage chamber temperature control failure) or non-delivery? Please specify: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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6 | Transportation (Medicinal Products Requiring Special Conditions) | Yes | No | N/A |
6.1 | Does your company transport scheduled drug products such as narcotics or psychotropics? |
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6.2 | If yes, do you maintain a safe and secure means of transportation in accordance with requirements laid down by your country medicines regulatory authority? |
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6.3 | Briefly describe the security measures in place at your company to ensure secure transportation of scheduled drug products: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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6.4 | Briefly describe the customer checks performed and documented at time of delivery of a scheduled drug product: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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6.6 | Does your company transport radioactive or highly leachable toxic products?
If yes, please specify the safety precautions taken when transporting these types of products: …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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6.7 | Is a Material Safety Data Sheet (MSDS) provided with each order? |
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7 | Premises (Distribution Warehouses and Hubs) | Yes | No | N/A |
7.1 | Do you conduct physical handling of the product such as: |
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7.1a | - Warehousing and Storage for greater than 24 hours |
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7.1b | - Repackaging |
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7.1c | Do you re-label the product? Palette label? Container label? If yes, do you edit labels in your facilities? |
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7.2 | Does the company utilise transportation hubs? If yes and products are unloaded at hubs, what is the maximum storage period? ………………………………………………………………………….. |
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7.3 | Have you performed a GDP audit of the hubs used by your company? |
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7.4 | Is a Quality Agreement in place with these hubs used by your company? |
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7.5 | Briefly describe how the quality of medicines is assured during unloading, storing and loading at hubs? …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… …………………………………………………………………………………… |
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8 | Complaints – Recalls | Yes | No | N/A |
8.1 | Does the company operate a complaint procedure that describes actions to be taken? |
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8.2 | Does the complaint procedure contain recall criteria? |
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8.3 | Is there a procedure ensuring that customers are informed in the event of serious quality problems? |
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8.4 | Are complaints recorded and investigated to identify the origin and reason? |
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8.5 | Does the company have a procedure in place for prevention of counterfeit products entering the supply chain? |
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9 | Returned Goods | Yes | No | N/A |
9.1 | Are returned products handled according to written procedures? |
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9.2 | Is there a system in place to ensure that returned goods are placed in a separate location in the vehicle storage chamber (separate from saleable product)? |
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10 | Additional Comments | |||
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