At a Leading Minds Seminar, an industry thought leader and practitioner led an Community Forum Discussion with the group to share experiences with how to deal with auditor’s questions on CRT product handling.
Regulators want to know – do your processes match your policy? Are your policies and practices streamlined across your sites as a global organization?
The discussion group agreed most companies fall into one ‘camp’, as outlined by EFPIA,
1) Those who use stability data during shipping
2) Those who use a stability budget if something goes wrong with the product and have to determine the impact to the product.
Depending on where you ship there are different definitions of Controlled Temperature products. In the US, the USP defines CRT as 20-25C°; whereas in Europe it can be <30C° for the same product with same stability data. How do you ship universally then and assign label claim information? Bottom line, use the data to decide what’s right for your product.
Point is: we as an industry need to be using the same terms in the same way. The opportunity is to create standards for labeling and the storage temperature requirements.
The discussion group came up with a list questions they’ve been asked by regulators how they are handling and shipping CRT products. These are some of the auditor’s ‘challenges’ and the group’s answers to them.
«Show me data that supports those shipping ranges.» You could show them:
«How are you maintaining this storage requirement during shipping? Country X over here has a package insert says "Do not freeze". But your labels from HQ don’t indicate this.»
«Your distribution site practices seem sufficient, but can I see your corporate policy on temperature controlled shipping?»
«What are your allowable shipping ranges and how can you prove it?»
«Show me your shipping qualification»
Point is: Have data to support auditor’s inquires. The opportunity is to show that we are treating CRT products similarly to products stored at refrigerated temperatures.
Ok well the discussion group didn’t quite say regulators called anyone lazy. But the question was asked «are we getting too wide with our shipping allowances?».
Regulators also don’t understand why some shipping ranges are so wide – with a stability budget allowing temperatures of -20 °C..+ 40 °C, are we really exposing our products to +40 °C for a week, continuously? No of course not. But the opportunity remains, if we have a stability budget allowing +40 °C for a week, how are we managing shipments to continuously improve towards shipping within a narrower range?
Historical estimates suggest that 38% of General Cargo shipments experience some time between +30 °C..+40 °C. What are some options for more controlled temperatures during shipping?
What questions have you been asked by regulators on CRT shipping practices? Please join the discussion – and provide examples in comments section below to share with colleagues.
ELPRO is big on education. Join us at an upcoming seminar soon. Attendance is complimentary for pharmaceutical manufacturers.
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