Glossary
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February 27, 2012
According to FDA:
1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single enti…
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February 27, 2012
A two-fold program to [1] develop a pharmaceutical, biologic or medical device to meet predefined product quality, safety and efficacy specifications; and [2] design the manufacturing processes and controls around that pharmaceutical, biologic or med…
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February 27, 2012
Process to be defined in the MSA or Supply Agreement where by changes to the Work Order will be initiatied, agreed and approved.…
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February 27, 2012
To introduce a product back into the process and repeat steps that are part of the established manufacturing process. Continuation of a process step after an in-process control test shows the process to be incomplete is not considered reprocessing. F…
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February 27, 2012
The process by which genetic information contained in DNA is transcribed or copied into a molecule of RNA.…
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February 27, 2012
A process for transferring recombinant genetic information into a recipient cell or host organism.…
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February 27, 2012
A population of organisms produced from a single parent cell where the derived cells are genetically identical.…
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February 27, 2012
A triplet of nucleotides in the DNA or RNA molecules that code for one of the 20 amino acids in proteins or as a signal to stop or start protein production.…
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February 27, 2012
Chemical packages of hereditary information, made up of long coiled chains of DNA. Humans have 22 different pairs of chromosomes plus either two x-chromosomes or one x and one y-chromosomes depending on the gender.…
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February 27, 2012
A biotechnologically produced substance such as proteins, nucleic acids and other naturally occurring compounds derived from living cells for pharmaceutical applications.…
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