Acronyms
Is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Who is the FDA (Food and Drug Administration)?
This is what the 5 principals of Good Documentation Practices are known
What is ALCOA?
A=Attributable
L=Legible
C=Contemporaneous
O=Original
A=Accurate
21 CFR Part 11 covers what part of our data
What is electronic records and electronic signatures?
This must occur on all facilities, equipment, or instruments
What is an IQ (Installation Qualification) and OQ (Operational Qualification)?
Any deficiency noted by the FDA is cited on this.
What is a Form 483?
These contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
What are cGMP (Current Good Manufacturing Practices)?
All documentation must be written with this type of ink.
What is indelible?
A secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record.
What are audit trails?
Determination that a piece of equipment/instrumentation performs according to established criteria under actual operating conditions
What is a PQ (Performance Qualification)?
This was created to protect poisonings, such as the deaths from cyanide place in Tylenol capsules in 1982.
What is Tamper Resistant Packaging?
This is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an unapproved drug or biological product to humans.
What is an IND (Investigational New Drug Application)?
To correct an error, a single line is drawn to avoid doing this to the original data.
What is obliterate or obscure?
Copies of the original data that is stored as photocopies, electronic copies, or other accurate reproductions of the original records.
What is True Copy?
This is a written plan for stating how the validation will be conducted and defining acceptance criteria?
What is a Validation Protocol?
The time period a sponsor must wait before initiating a clinical trial after an IND is submitted.
What is 30 days?
For 200 years, this organization has created the standards to ensure quality and safety for medicines, supplements, and foods.
What is the USP (United States Pharmacopeia)?
As defined in the SOP-GEN-009: Weights are written to the same number of significant figures as defined by the limitations of this.
What is a Weighing Balance?
With the appropriate controls these can be used instead of handwritten signatures or initials in any CGMP required record
What are electronic signatures?
The closeness of test results obtained to the true value
What is Accuracy?
These can never be injected to use to see if the system is suitable for use
What are samples?
They are responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union
What is the EMA (European Medicines Agency)?
GMP records must be entered and filled out at this time.
What is when the activity or data occurs?
This data should also be maintained throughout the record’s retention period to reconstruct the CGMP activity
What is metadata?
This is needed to be requested prior to any validation activity.
What is a change control?
This book by Upton Sinclair about the meat packing industry lead to the creation of the FDA
What is The Jungle?