国外供应商审计GMPQuestionnaire..doc

COMPANY PROFILE SUPPLlER: DATE : 2004-06-16 ADDRESS: _____ _______________________________ PLANT SITE TELEPHONE : PLANT SITE FAX NUMBER : MAIN OFFICE TELEPHONE :) Name and address of parent organization, if applicable ____________________________________________________________________________ Plant Manager: ___ _________________________________________________ QA/QC Manager: __ _______________________________________ Production Manager: __ ________________________________ R&D/Technical Services ___________________________________________ Materials that will be provided:  Answers to questions: As our Company is sending this questionnaire to all its suppliers, some of the questions may not be relevant, in which case please mark the comment box with N/A (not applicable). No. GENERAL YES NO COMMENTS Is the facility ISO certified? If so, which standard and since when? Do you have a written training program for all employees? Does this include cGMP training? Please indicate how many shifts are at the manufacturing facility Are training records maintained for all employees? If so how long are the training records kept? Do employees working in certain areas specialised training (i.e. Laboratories, classified areas, packaging)? Is the training competency based? Are there procedures and controls in place to ensure cross-contamination does not occur of materials being stored or transported in reusable containers? Are the environmental conditions adequate for raw material and finished goods to ensure material stability? Are personnel suitably dressed where a lack of suitable attire could adversely affect the product? Is your warehouse temperature controlled and or monitored? Do the facilities provide adequate space to prevent mixes? Are there cleaning procedures for the facility and a cleaning schedule? Is there an insect and rodent contr