PH 116.1 - Pharmaceutical Manufacturing (Lab)

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By: Juan Carlos Cornelio
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Decks in this class (13)

PRELIM 01 - PIC/S Part 1
Meaning of pic s 1,
Meaning of gmp 2,
Is a wide ranging concept which c...
30  cards
PRELIM 02 - Annex 1 Glossary (Manufacture of Sterile Medicinal Products)
An enclosed space with interlocke...,
An established relevant measure t...,
An established relevant measure g...
77  cards
PRELIM 03 - Annex 2A and 2B Glossary (Manufacture of Advanced Therapy Medicinal Products for Human Use)
Is defined in the relevant cta or...,
A chemical or biological substanc...,
Meaning of atmp 3
61  cards
PRELIM 04 - Annex 3 Glossary (Manufacture of Radiopharmaceuticals)
Handling and radiolabeling of kit...,
Production quality control and re...,
Shielded workstations for manufac...
4  cards
PRELIM 05 - Annex 6 Glossary (Manufacture of Medicinal Gases)
Any gas intended to be an active ...,
Separation of atmospheric air int...,
Gas which when packaged under pre...
24  cards
PRELIM 06 - Annex 11 Glossary (Computerized Systems)
Software installed on a defined p...,
A computerized system individuall...,
Software commercially available w...
8  cards
PRELIM 07 - Annex 13 Glossary (Manufacture of Investigational Medicinal Products)
A procedure in which one or more ...,
Usually refers to the subjects be...,
Usually refers to the subjects in...
20  cards
PRELIM 08 - Annex 15 Glossary (Qualification and Validation)
A science and risk based validati...,
A formal system by which qualifie...,
Is documented evidence that an ap...
27  cards
PRELIM 09 - Annex 16 Glossary (Authorized Person and Batch Release)
The certification in a document b...,
A signed statement by an authoriz...,
Is an entity which comprises all ...
5  cards
PRELIM 10 - Annex 17 Glossary (Real Time Release & Parametric Release)
A planned set of controls derived...,
A process parameter whose variabi...,
A physical chemical biological or...
6  cards
PRELIM 11 - Annex 20 Glossary (Quality Risk Management)
Persons with the competence and a...,
The ability to discover or determ...,
Damage to health including the da...
23  cards
PRELIM 12 - Glossary (Miscellaneous)
Established criteria giving early...,
A defined quantity of starting ma...,
A distinctive combination of numb...
47  cards
PRELIM 13 - Introduction to Manufacturing Pharmacy
The complete set of activities to...,
Current good manufacturing practi...,
Its objective is to prescribe sta...
54  cards

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PH 116.1 - Pharmaceutical Manufacturing (Lab)

  • Class purpose General learning

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