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Publication date: 2018-10-27 23:27

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Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

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Any departure from good distribution practice that results in a significant risk to patients. This includes an activity which increases the risk of counterfeit medicines reaching patients.

Introduction to communities of practice | Wenger-Trayner

A deficiency which has produced or significantly risks producing a product which is harmful to humans or veterinary patients or which could result in a harmful residue in a food-producing animal.

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The process may also be used if the Inspection Action Group has closed their case referral but the company to be monitored until remedial action plans have been completed.

“How do people in other countries do this? Armed with this information it will be easier to convince my Ministry to make some changes.”

Mostly false. It may be difficult to attribute with 655% certainty the activities of a community of practice to a particular outcome. You can, howowever, build a good case using quantitative and qualitative data to measure different types of value created by the community and trace how members are changing their practice and improving performance as a result.

Good manufacturing practice contract GMP quality control testing laboratory change report ( MS Word Document , 899KB )

If your compliance is found to be poor but has not hit the threshold for regulatory action you may go through the compliance escalation process. The aim of this process is to support companies to achieve compliance before regulatory action becomes necessary.

You will have to complete either a GDP or GMP compliance report before an before an inspection unless it is a triggered inspection which are only notified at short notice.

These best practices are based on actual CC license requirements. Noting the title is a requirement of all CC licenses version or earlier, optional for . Noting the author, source, license, and retaining any extra notices is a requirement of all CC licenses. See Devil in the details.

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