Monitoring is conducted at least monthly? Yes No N/A Draft 247 CMR 17.24 (8)(b) Best Practice Item# Requirements Yes No N/A Additional Information Frequency of Monitoring (continued) Does the pharmacy ensure that environmental monitoring samples are collected from ISO Class 5, then ISO Class 7, 121 and then ISO Class 8? Draft 247 CMR 17.24 (9) General Does the pharmacy ensure that personnel performing environmental monitoring are qualified and have demonstrated competency and proficiency in all the following sampling techniques? media selection, Yes No Yes media preparation, No Yes No sample collection, Yes No Yes 122 incubation protocols, No Yes No Yes identification of positive results, No Yes No proper handling of samples for contracted lab distribution, and proper disposal of sampling plates Proper selection and use of equipment Draft 247 CMR 17.24 (10-11) If the pharmacy has qualified internal personnel collect environmental monitoring samples, do they validate sampling 123 procedures at least once every six months through a qualified third-party vendor? Draft 247 CMR 17.24 (21) Best Practice Is the equipment used for environmental monitoring maintained and calibrated for use at annually or more 124 frequently in accordance with manufacturer’s specifications? Draft 247 CMR 17.24 (12) Documentation Required Does the pharmacy ensure environmental monitoring samples are incubated at the appropriate temperature and 125 length of time? Draft 247 CMR 17.24 (17) Does the environmental monitoring for viable organisms include negative controls? 126 Draft 247 CMR 17.24 (18) Does the pharmacy ensure that all Staphylococcus organisms are identified as coagulase positive or negative? 127 Draft 247 CMR 17.24 (19) Does the pharmacy utilize a method for collection of viable air and surface samples? 128 Draft 247 CMR 17.24 (20) Best Practice Does the pharmacy obtain a Promotion Certificate” for environmental monitoring plates to validate that the “Growth 129 media can support microbial growth? 247 CMR 17.24 (22) Documentation Required Does the pharmacy utilize plates intended for environmental monitoring? 130 Draft 247 CMR 17.24 (23) Item# Requirements Yes No N/A Additional Information
Monitoring is conducted at least monthly? Draft 247 CMR 17.24 (8)(b) Best Practice Yes No N/A Item# Requirements Yes No N/A Additional Information Frequency of Monitoring (continued) 121 Does the pharmacy ensure that environmental monitoring samples are collected from ISO Class 5, then ISO Class 7, and then ISO Class 8? Draft 247 CMR 17.24 (9) General 122 Does the pharmacy ensure that personnel performing environmental monitoring are qualified and have demonstrated competency and proficiency in all the following sampling techniques? media selection, media preparation, sample collection, incubation protocols, identification of positive results, proper handling of samples for contracted lab distribution, and proper disposal of sampling plates Proper selection and use of equipment Draft 247 CMR 17.24 (10-11) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No 123 If the pharmacy has qualified internal personnel collect environmental monitoring samples, do they validate sampling procedures at least once every six months through a qualified third-party vendor? Draft 247 CMR 17.24 (21) Best Practice 124 Is the equipment used for environmental monitoring maintained and calibrated for use at annually or more frequently in accordance with manufacturer’s specifications? Draft 247 CMR 17.24 (12) Documentation Required 125 Does the pharmacy ensure environmental monitoring samples are incubated at the appropriate temperature and length of time? Draft 247 CMR 17.24 (17) 126 Does the environmental monitoring for viable organisms include negative controls? Draft 247 CMR 17.24 (18) 127 Does the pharmacy ensure that all Staphylococcus organisms are identified as coagulase positive or negative? Draft 247 CMR 17.24 (19) 128 Does the pharmacy utilize a method for collection of viable air and surface samples? Draft 247 CMR 17.24 (20) Best Practice 129 Does the pharmacy obtain a “Growth Promotion Certificate” for environmental monitoring plates to validate that the media can support microbial growth? 247 CMR 17.24 (22) Documentation Required 130 Does the pharmacy utilize plates intended for environmental monitoring? Draft 247 CMR 17.24 (23) Item# Requirements Yes No N/A Additional Information
sterile-compounding-inspection.docx