8.10 Do you introduce changes according to a written procedure? Yes No N/A 8.11 Do you inform your customers about changes? Yes No N/A 8.11.1 If yes, how do you inform them? 8.11.2 Do you wait for approval of customers on major changes? Yes No N/A 8.11.3 Would you notify your Customer in writing prior to implementing significant changes in analytical test methods, specifications or Yes No N/A manufacturing procedures/process, use of raw material source form animal, human or vegetable origin? 8.11.4 Would you notify your Customer in writing prior to implementing major Yes No N/A changes in plant, site of production or contract manufacturing? Describe how senior management is informed of quality related 8.12 issues: 8.13 Do you supply a Certificate of Analysis with each batch? Yes No N/A 8.13.1 If ‘YES’, will the Certificate of Analysis include actual analytical results? Yes No N/A 8.14 Will you supply a Certificate of Sterilization with each batch? Yes No N/A Packaging, Labelling and Shipping 9.1 If containers are reused, are they cleaned via validated cleaning procedures Yes No N/A and inspected before use? 9.2 Are container labels reconciled and the number of labels printed, used and Yes No N/A destroyed recorded? 9.3 Is each bag/container labelled with the lot/batch no.? Yes No N/A 9.4 Will each bag/container on a pallet have the lot/batch no. and/or Yes No N/A description clearly visible on it? 9.5 Do you keep records of all shipments to customers, including batch number Yes No N/A and quantity? 9.6 Do you use your own transport for shipping to customers Supplier- Owned Contractor N/A or do you use a contractor? 9.7 If you use a contractor, Do you have an agreed contract between parties Yes No N/A which specifies required shipping conditions for materials? 9.7.1 If yes, have they been evaluated? Yes No N/A 9.8 Is the shipping temperature controlled? Yes No N/A 9.9 Have stability studies for temperature controlled shipments been Yes No N/A performed?
8.10 Do you introduce changes according to a written procedure? Yes No N/A 8.11 Do you inform your customers about changes? Yes No N/A 8.11.1 If yes, how do you inform them? 8.11.2 Do you wait for approval of customers on major changes? Yes No N/A 8.11.3 Would you notify your Customer in writing prior to implementing significant changes in analytical test methods, specifications or manufacturing procedures/process, use of raw material source form animal, human or vegetable origin? Yes No N/A 8.11.4 Would you notify your Customer in writing prior to implementing major changes in plant, site of production or contract manufacturing? Yes No N/A 8.12 Describe how senior management is informed of quality related issues: 8.13 Do you supply a Certificate of Analysis with each batch? Yes No N/A 8.13.1 If ‘YES’, will the Certificate of Analysis include actual analytical results? Yes No N/A 8.14 Will you supply a Certificate of Sterilization with each batch? Yes No N/A Packaging, Labelling and Shipping 9.1 If containers are reused, are they cleaned via validated cleaning procedures and inspected before use? Yes No N/A 9.2 Are container labels reconciled and the number of labels printed, used and destroyed recorded? Yes No N/A 9.3 Is each bag/container labelled with the lot/batch no.? Yes No N/A 9.4 Will each bag/container on a pallet have the lot/batch no. and/or description clearly visible on it? Yes No N/A 9.5 Do you keep records of all shipments to customers, including batch number and quantity? Yes No N/A 9.6 Do you use your own transport for shipping to customers or do you use a contractor? Supplier- Owned Contractor N/A 9.7 If you use a contractor, Do you have an agreed contract between parties which specifies required shipping conditions for materials? Yes No N/A 9.7.1 If yes, have they been evaluated? Yes No N/A 9.8 Is the shipping temperature controlled? Yes No N/A 9.9 Have stability studies for temperature controlled shipments been performed? Yes No N/A