Version Replaces Page Effective Supplier Qualification Questionnaire. Company Name:

Transcription

1 Page 1 Company Name: Manufacturing Site Address: Business Address (if different): Telephone No: Fax No: E Mail: Is the Company a division/subsidiary of another corporation? If Yes, Please Specify Telephone No: Fax No: E Mail: Yes No N/A What percentage of your business is with the Pharmaceutical Industry? Have you ever been audited (by Questionnaire or Site Visit) for Quality by Matrix Marketing GmbH? Yes No If Yes, please indicate the most recent date and type of audit applicable: This questionnaire was completed by: Name Job Title Signature Date Questionnaire reviewed for Matrix Marketing GmbH lead audit site by: Signature: Date

2 Page 2 Legislation and Risk Management Are all workers above 15 years old? Can you confirm that only workers (>18 years old) perform hazardous work, and work at night? Are workers paid at rates at least equivalent to national minimum and basic needs levels, and in full compliance with the law, and is overtime paid at a premium rate? Can you confirm that working hours do not exceed 48 hours/week on a normal basis and that overtime does not exceed 12 hours/week and is voluntary? Are there rights of workers to join trade unions (or other representative organizations) and to bargain collectively respected? Also, are worker representatives able to carry out their duties without discrimination and do they have access to their members in the workplace? Can you confirm that your company does not allow corporal punishment, mental or physical coercion or verbal abuse or any form of sexual harassment, and the working environment free from all forms of discrimination? Can you confirm that you do not make deductions from wages as a disciplinary measure? Are your raw materials free from being directly or indirectly associated with labour practices violating any of the above conditions mentioned (e.g. harvesting or processing), and/or associated with harm to protected species or habitats? Do you have all required permits and licenses according to legislation, especially business and production permits/licenses such as Fire, Environment, and are you currently compliant with local legislation, permit and license requirements? If yes please indicate which ones? Do you have insurance coverage for general product liability? If yes, please indicate the name of your insurance company and the amount coverered.

3 Page 3 Security, Health, Safety & Environment (HSE) Do you have a site security program which includes a secure fence surrounding the facility or equivalent? Do employees, contractors, visitors have badges and/or are required to sign a log book? Are you currently compliant with all relevant HSE regulatory requirements? Do you have a health and safety committee on which workers are represented? Do workers who handle hazardous materials receive an annual health check? Can you confirm the absence of significant health safety and environmental risks at your site? Can you confirm that you did not register any cases of illness, injury and incident in the past 12 months? Are you aware of all health and safety and environmental legislation relevant to your activities? Do you often test fire, HSE incident response systems? Do you have material safety data sheets (MSDS) for each chemical used in a language all your workers can understand? Are all containers for hazardous materials adequately labeled?

4 Page 4 Approximately how many employees do you have? Organization and Quality systems Site total R&D QA/QC Production Does the company have a policy on HSE (Health, Safety, & Environment)? Do you have a Quality Management (QM) System in place? Is the QM or HSE system certified? Please specify the type of certificate; ISO 900x/ GMP/ Other. Certificate expiry date:.. ISO1400x/ Other. Certificate expiry date:.. Do you have an independent QA/QC department? Do you have a change control system? Is there a procedure to notify customers of change? Do you have procedure on how to handle customer complaints? Do you have a deviation system or a corrective and preventative action (CAPA) programme? Do you have approved manufacturing instructions? (e.g. batch records) Do you have documented procedures for equipment and facility cleaning? Do you have an employee training programme?

5 Page 5 Analytical Capability Do you test your products to established specifications? Do you test your products on site? Is QC testing carried out by a third party? If Yes, please provide details: Do you have an agreement with them? Do you use your suppliers analytical data on your C of A? Who generates the C of A and how? (e.g. transcribe supplier data; use internal test data results etc) You Supplier N/A Do you have product stability data? What are the acceptance criteria of raw materials? Please specify if Other: Testing Other Suppliers C of A Are C of A s issued for each batch? Vendor assurance Do you use a list of approved suppliers? Do you audit your suppliers? If Yes please provide details (e.g. paper, physical audit etc) Are established Purchase Specifications used? Can you provide traceability back to the original raw material manufacturer (if requested)? Would you be prepared to request the original manufacturer(s) to complete a copy of this Questionnaire on Matrix Marketing GmbH s behalf and visibility? Do you provide certificates for TSE/BSE? Please provide information on who generates TSE/BSE certificates and how :

6 Material handling How is material status controlled? (i.e. Physical, system or labelling) Page 6 Physical System Labelling How is rejected material controlled? (i.e. Physical, system or labelling) Is there more than one site or plant used for the manufacture of the specified material(s)? If yes please provide details as to location of the site/plant Are there any hazardous or sensitizing materials manufactured, packaged or repackaged on your site? (e.g. Cytotoxins, herbicides, rodenticides or penicillins) Physical System Labelling If Yes are these located in a separate facility and/or are there appropriate controls in place to prevent cross contamination? Do any production areas have special containment needs? Do you have an equipment calibration programme? Are re-usable containers used? Are packaging operations segregated from production? Are there systems in place for disposal of waste material? If Yes, please provide details of how you do this (e.g. internally, 3 rd party incineration etc) Are tamper-proof seals used for the outer container? Do you have appropriate packaging for dangerous goods shipped by air freight according to IATA/UN requirements? Do you operate a First in First out policy? Where chemicals are sourced from a 3 rd Party for onward delivery do you deliver in the Manufacturer s original packaging? Is a list of approved shipping agents in use for finished goods?

7 Page 7 Which of the following activities are you involved in? Please tick all relevant boxes. (On-Site refers to your own Warehouse, Manufacturing Site, or Distribution Centre Off-Site refers to your supplier s Warehouse, Manufacturing Site, or Distribution Centre) Warehousing On-Site Off-Site N/A Repackaging On-Site Off-Site N/A Labelling On-Site Off-Site N/A Distribution On-Site Off-Site N/A Other please specify: On-Site Off-Site N/A