Organization and Quality systems Approximately how many employees do you have? Site total …………………….. R&D …………………….. QA/QC …………………….. Production …………………….. Does the company have a policy on HSE (Health, Safety, & Environment)? Yes □ No □ N/A □ Do you have a Quality Management (QM) System in place? Yes □ No □ N/A □ Is the QM or HSE system certified? Please specify the type of certificate; ISO 900x/ GMP/ Other ………………. ISO1400x/ Other ………………. Yes □ No □ N/A □ Certificate expiry date: ……………….. Certificate expiry date: ……………….. Do you have an independent QA/QC department? Yes □ No □ N/A □ Do you have a change control system? Yes □ No □ N/A □ Is there a procedure to notify customers of change? Yes □ No □ N/A □ Do you have procedure on how to handle customer complaints? Yes □ No □ N/A □ Do you have a deviation system or a corrective and preventative action (CAPA) programme? Yes □ No □ N/A □ Do you have approved manufacturing instructions? (e.g. batch records) Yes □ No □ N/A □ Do you have documented procedures for equipment and facility cleaning? Yes □ No □ N/A □ Do you have an employee training programme? Yes □ No □ N/A □ Analytical Capability
Do you test your products to established specifications? Yes □ No □ N/A □ Do you test your products on site? Yes □ No □ N/A □ Is QC testing carried out by a third party? If Yes, please provide details: Yes □ No □ N/A □ Do you have an agreement with them? Yes □ No □ N/A □ Do you use your suppliers’ analytical data on your C of A? Yes □ No □ N/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? Yes □ No □ N/A □ What are the acceptance criteria of raw materials? Please specify if Other: Testing □ Suppliers C of A □ Other □ Are C of A’s issued for each batch? Yes □ No □ N/A □ Vendor assurance Do you use a list of approved suppliers? Yes □ No □ N/A □ Do you audit your suppliers? If Yes please provide details (e.g. paper, physical audit etc) Yes □ No □ N/A □ Are established Purchase Specifications used? Yes □ No □ N/A □ Can you provide traceability back to the original raw material manufacturer (if requested)? Yes □ No □ N/A □ 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? Yes □ No □ N/A □ Do you provide certificates for TSE/BSE? Yes □ No □ N/A □ Please provide information on who generates TSE/BSE certificates and how : Material handling How is material status controlled? (i.e. Physical, system or labelling) Physical □ System □ Labelling □ How is rejected material controlled? (i.e. Physical, system or labelling) Physical □ System □ Labelling □ Is there more than one site or plant used for the Yes □ No □ N/A □
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) Yes □ No □ N/A □ If Yes are these located in a separate facility and/or are there appropriate controls in place to prevent cross contamination? Yes □ No □ N/A □ Do any production areas have special containment needs? Yes □ No □ N/A □ Do you have an equipment calibration programme? Yes □ No □ N/A □ Are re-usable containers used? Yes □ No □ N/A □ Are packaging operations segregated from production? Yes □ No □ N/A □ Are there systems in place for disposal of waste material? If Yes, please provide details of how you do this (e.g. internally, 3rd party incineration etc) Yes □ No □ N/A □ Are tamper-proof seals used for the outer container? Yes □ No □ N/A □ Do you have appropriate packaging for dangerous goods shipped by air freight according to IATA/UN requirements? Yes □ No □ N/A □ Do you operate a “First in First out” policy? Yes □ No □ N/A □ Where chemicals are sourced from a 3rd Party for onward delivery do you deliver in the Manufacturer’s original packaging? Yes □ No □ N/A □ Is a list of approved shipping agents in use for finished goods? Yes □ No □ N/A □ 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 □