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Crucigrama Sopa de Letras Hoja de Trabajo
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GMP Breakout

Horizontales
Whether it is done with pen and paper or electronically, the person who completes the work must be the one to _____________ the work.
Records must be _________ and consistent with Company SOPs and the GMPs.
Documentation must be legible & ______________.
Access control process is mandatory for control & _________ on who is doing what.
Guidance/checklist that reflects the FDA’s requirements regarding CGMP records.
Complete the definition of ALCOA? Attributable, __________, Contemporaneous, Original, Accurate, Complete
Study evidence/results should be __________ as they are observed.
Verticales
__________ procedures including any changes, shall be drafted, reviewed and approved by the appropriate organizational units of the author and by the quality unit.
If it wasn’t ___________, it wasn’t done.
FDA expects that data be ___________ & accurate.
Investigators and institutions should maintain adequate, accurate and ________ source documents.
What is one of the most important regulations we must follow in our business?