History
Performed to assess GMP compliance of other parties.
What are audits/inspections.
Not performing this test before sample analysis.
What is System Suitability Test.
Analytical Food Laboratories, Inc.
(Oct 10, 2024)
The meaning of two "A" letters in "ALCOA+".
What is "Attributable" and "Accurate".
This is the meaning of the abbreviation GMP.
What is Good Manufacturing Practice.
Not following written procedures for peforming these annual activities on instruments.
What are Maintenance and Qualification.
These are mandatory to link data to ensure full traceability.
What are cross-references.
This is the meaning of the abbreviation FDA.
What is Food and Drug Administration.
Adding these will help to ensure data completeness.
What are page numbers, together with total page number.
Event, in 1937, which triggered the creation of first modern regulations for pharmaceutical manufacturing.
What is sulfanilamide disaster (USA).
A drug company used diethylene glycol (a toxic industrial solvent) to formulate a liquid version of sulfanilamide. A medicine used to treat infections- 100 people died, amongst them many children.
Event in 1960s, that is concidered the most tragic event in the history of pharmaceutical manufacturing.
What is Thalidomide tragedy (Europe).
10,000 cases of infant deformities