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Glossary

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February 27, 2012
An umbrella contract between two companies which defines the terms of business, under which work-orders can be incorporated. Enables more agile execution. Must be integrated with the Quality Agreement and often includes Quality Agreement terms and de…  Read More »

February 27, 2012
Transgenic animals or plants are organisms living with an altered gene or genes as a result of genetic engineering.…  Read More »

February 27, 2012
The process by which information is transferred from DNA by RNA specifying the amino acid sequence in a protein.…  Read More »

February 27, 2012
A general term for a number of essential substances the human body cannot synthesize itself.…  Read More »

February 27, 2012
A cell bank made form a single vial of the master cell bank.…  Read More »

February 27, 2012
The agency of the United Nations founded in 1947 for the purpose of promoting health.…  Read More »

February 27, 2012
Therapeutic Goods Administration. Australia’s drug regulatory body.…  Read More »

February 27, 2012
An FDA post-audit letter notifying the manufacture of adverse inspections findings requiring a reply with defined plans for remediation.…  Read More »

February 27, 2012
See Summary Basis of Approval.…  Read More »

February 27, 2012
See Target Product Profile.…  Read More »

February 27, 2012
A method of detecting and visualizing radioactivity concentration in an intact test subject.…  Read More »

February 27, 2012
See Drug Substance.…  Read More »

February 27, 2012
A cosmetic product claimed to have medicinal or drug-like benefits.…  Read More »

February 27, 2012
Alternate term for API.…  Read More »

February 27, 2012
A chemical produced in high volumes with low value and used for a broad spectrum of applications.…  Read More »

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