国外供应商审计gmpquestionnaire

Company: Type of Document:Questionnaire Pharma ResourcesPage 1COMPANY PROFILE SUPPLlER: DATE : 2004-06-16ADDRESS: _ _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 sampling, and test methods? 70. Are in process assembly and inspection test results documented? 71. Is non-conforming material promptly identified and segregated? 72. Are there procedures and controls to prevent cross-contamination between lots and are these procedures documented? Company: Type of Document:Questionnaire Pharma ResourcesPage 8No. GENERAL YES NO COMMENTS73. Are materials properly labelled to preclude error in issuance? 74. Are there procedures for the control and issuance of material? 75. Are materials stored and handled in a manner designed to prevent damage, mix- up, contamination, and other adverse effects? 76. When computers are used as a part of an automated production or QA system, are all program changes made through a formal approval procedure? 77. Are such changes documented according to a written procedure? 78. Is there an individual designated to proof read labels and other labelling for accuracy and identity prior to use? 79. Is each labelling or packing operation separated physically or partially in a manner designed to prevent mix-ups? 80. Prior to implementation of a labelling and packing operation is there an inspection of the operation area to assure that all labels from a prior operation are removed? 81. Are any items found during such an inspection destroyed, disposed of or returned to storage prior to start-up of the new or different packing or labelling operation? 82. Are labels stored and maintained in a manner that provides identification and prevents mix-ups? 83. Is there a system for assuring that only current labels are retained and obsolete labels destroyed? 84. Is there a finished product inspection after in process? Company: Type of Document:Questionnaire Pharma ResourcesPage 9No. GENERAL YES NO COMMENTS85. Is there a current product material specification? 86. Is there an analytical laboratory or physical testing laboratory available to do the testing? Is the laboratory of proper design, with appropriate test instruments and managed by technically qualified staff? 87. Are the laboratories (Microbiology & Chemistry) located at the manufacturing site?88. Is any testing performed by a contract lab?If yes, have the contract lab been audited?89. Is there a reagent control program? (i.e. date reagent received, date opened, date expired90. Do you have a system in place to handle with Out Of Specifications results?91. Are tests performed to ensure that all requirements of the specification are met? 92. Is there a reference standard program?Is there a reference standard available for the API under consideration?93. Is the inventory and certificates of reference standards maintained? If yes, can Certificates for each reference standard be supplied?94. Have you clearly defined the impurity profile of your API?Do you know at which stage each impurity could be formed? Are impurities available?95. Is there an approved SOP outlining the stability testing program?96. Does the stability program follow ICH Guidelines?97. How are the stability samples stored? (i.e. what type of container)Company: Type of Document:Questionnaire Pharma ResourcesPage 10No. GENERAL YES NO COMMENTS98. Are the stability chambers controlled and monitored temperature and relative humidity?99. Have the stability chambers been profiled for temperature and humidity distribution?(i.e. have hot and cold spots been identified?100. Are non-compendial laboratory tests for testing the API (i.e. impurities, solvents and Assay validated?If yes, are you aware that such validations programs, protocols meets the corresponding ICH Guidelines?101. Are there written acceptance/rejection criteria and procedures describing testing and sampling? 102. Are samples for each lot retained?If yes what is sample size based upon?103. Is finished product identified as approved for shipping? 104. Is final inspection and/or testing performed either by or under surveillance of QA/QC? 105. Does the QA/QC unit have final authority to accept or reject finished material? 106. Are records of inspection and test data maintained? If so, how long? 107. Prior to release, are all acceptance records cross-checked by a designated individual(s)? 108. Do records include or refer to the location of manufacturing, the dates of manufacturing, the quantity for shipment, and control number used? 109. Is final product held in quarantine or otherwise adequately controlled until it is officially released for sale? 110. Is the facility capable of storing final product under conditions of temperature, humidity, etc., Company: Type of Document:Questionnaire Pharma ResourcesPage 11No. GENERAL YES NO COMMENTSconsistent with the label “requirements”? 111. Do written procedures provide for: a. Rejection Forms? b. Identification of discrepant material? c. Segregation of non-conforming material from normal production? d. Corrective action? e. Control of waste? 112. Are defective and “incomplete“ materials identified, segregated, and documented as to inspection status? 113. Are management reports on non-conforming material published and acted upon? 114. Are there written procedures for reprocessing? 115. Do these procedures describe the reprocessing equipment and include any special QA methods or tests? 116. Are products to be reprocessed, identified, and segregated from other products? 117. Are prior QA checks repeated on processing products if reprocessing could adv