C
chum84
The business I'm doing a project for currently reconstitutes drugs and sells them off. This reconstitution essentially creates a drug of a specific concentration and a specific volume using a more concentrated form of the drug (powerdered or aqueous) and a base solution (saline or glucose). Essentially its making a more diluted form of a drug from its concentrated form. The dosage is based on measurements gathered from a patient.
The actual reconstitution process occurs within a CDSC Laminar Flow cabinet - that is, a sterile cabinet. Testing of the product will be destructive.
Im thinking of excluding Part of Section 7.6: Control of Monitoring and Measuring Devices. I'm also unsure how to provide evidence/records of that the realisation process is meeting customer requirements. Heres my thinking/reasoning
EXCLUSION FROM 7.6
All work done is by employees manually. The process consists of drawing liquid using a syringe (concentrate) and then drawing another liquid to dilute it to its specific concentration (base solution). It is absolutely ridiculous to measure each sample of liquid taken out each time - taking it out of a sterile cabinet is not possible for electronic measuring and its absolutely inappropriate to use an electronic syringe/measuring and drawing device (if there is one) because you cannot assure its sterility (try autoclaving an electronic device haha!). The syringes are pre-calibrated to 1ml increments and come sterile. Having said that 1ml increments are quite large but it is totally acceptable to guesstimate inbetween measurements - its widely accepted by all doctors, organisations etc..., and doesnt have much bearing on a patient that you gave them 10.4 mls instead of 10.5 or 10.6. The valildation that the amount drawn up is done by the employee visually. Validation that the employee is competant to do this process is assessed every year by an accredited organisation.
Having said all that , i have no idea how to provide evidence that the product realisation process is conforming to customer requirements - even if i did make a check list of every step of the process, you couldnt take that checklist inside the cabinet (unsterile) and its just plain stupid to stop what you are doing after drawing say 5.5ml, then taking your hands outside the cabinet to write down you drew 5.5ml and ticking and signing it. Also unfeasable to get an assistant to look over your shoulder and verify what you are doing. I dont think i can provide evidence of conformity during manufacture - conformity in this case means following a manufacturing sheet that has been checked by an employee and verified and signed by a registered pharmacist. Evidence of conformity will be shown through any cases of people getting sick after administration of the drug, but that hasnt happened and wont.
I've got a series of checks and processes to fulfill the requirement for 7.5.2: Validation of processes for production and service provision.
Do you think i can exclude myself from PART of 7.6 Calibration of Measuring and Monitoring Devices clauses a-e, but not the other paragraphs?. How do i go about providing evidence of conformity during manufacture?
The actual reconstitution process occurs within a CDSC Laminar Flow cabinet - that is, a sterile cabinet. Testing of the product will be destructive.
Im thinking of excluding Part of Section 7.6: Control of Monitoring and Measuring Devices. I'm also unsure how to provide evidence/records of that the realisation process is meeting customer requirements. Heres my thinking/reasoning
EXCLUSION FROM 7.6
All work done is by employees manually. The process consists of drawing liquid using a syringe (concentrate) and then drawing another liquid to dilute it to its specific concentration (base solution). It is absolutely ridiculous to measure each sample of liquid taken out each time - taking it out of a sterile cabinet is not possible for electronic measuring and its absolutely inappropriate to use an electronic syringe/measuring and drawing device (if there is one) because you cannot assure its sterility (try autoclaving an electronic device haha!). The syringes are pre-calibrated to 1ml increments and come sterile. Having said that 1ml increments are quite large but it is totally acceptable to guesstimate inbetween measurements - its widely accepted by all doctors, organisations etc..., and doesnt have much bearing on a patient that you gave them 10.4 mls instead of 10.5 or 10.6. The valildation that the amount drawn up is done by the employee visually. Validation that the employee is competant to do this process is assessed every year by an accredited organisation.
Having said all that , i have no idea how to provide evidence that the product realisation process is conforming to customer requirements - even if i did make a check list of every step of the process, you couldnt take that checklist inside the cabinet (unsterile) and its just plain stupid to stop what you are doing after drawing say 5.5ml, then taking your hands outside the cabinet to write down you drew 5.5ml and ticking and signing it. Also unfeasable to get an assistant to look over your shoulder and verify what you are doing. I dont think i can provide evidence of conformity during manufacture - conformity in this case means following a manufacturing sheet that has been checked by an employee and verified and signed by a registered pharmacist. Evidence of conformity will be shown through any cases of people getting sick after administration of the drug, but that hasnt happened and wont.
I've got a series of checks and processes to fulfill the requirement for 7.5.2: Validation of processes for production and service provision.
Do you think i can exclude myself from PART of 7.6 Calibration of Measuring and Monitoring Devices clauses a-e, but not the other paragraphs?. How do i go about providing evidence of conformity during manufacture?