What does pedigree mean in pharmacy?
What does pedigree mean in pharmacy?
According to the US Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act, “a drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties …
What is track and trace in pharma?
Track and trace for pharmaceuticals lets you to pinpoint any item’s current and past locations in your supply chain. It’s a powerful tool that no pharma company can do without, especially as regulations mandate track and trace capabilities and specific requirements for recording and sharing supply chain data.
What is SAP in pharma?
SAP (SYSTEMS, APPLICATIONS, PRODUCTS IN DATA PROCESSING) IN PHARMACEUTICAL INDUSTRY. SAP systems are designed to solve the fragmentation of information in large business organizations and integrate the processes within a company to help managers in making efficient decisions.
What GMP means?
Good manufacturing practice
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
What is the meaning of Serialisation?
: to broadcast or publish (something, such as a story) in separate parts over a period of time. See the full definition for serialize in the English Language Learners Dictionary.
What is the meaning of ePedigree?
Epedigree. An epedigree (sometimes referred to as e-pedigree or electronic pedigree) is an electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form.
What are the requirements for epedigree?
As of 2008, most states have enacted some sort of pedigree requirement and many have also required epedigree. However, the existing epedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as pdf, text files or spreadsheets.
What is the difference between a pedigree and an epedigree?
“A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.” An epedigree is simply an electronic document which satisfies a pedigree requirement.
What is the legal definition of a mandate?
Kids Definition of mandate. 1 : an order from a higher court to a lower court. 2 : a command or instruction from an authority. 3 : the instruction given by voters to their elected representatives.
