Records
If you did not document it, you did not do it…
What is Good Documentation Practices?
A detailed written instructions to achieve uniformity of the performance of a specific function.
What is a SOP?
Good Manufacturing Practices
What is GMP?
Safety, Identity, Strength, Purity, and Quality of the product
What is SISPQ
The electronic information is complete, consistent and accurate throughout the its life cycle.
What is Data Integrity?
Documented evidence(s) that a employee that has completed the necessary training.
What is a training record?
An atypical, abnormal, or unplanned incident or event that is a departure from an approved standard with potential to impact quality.
What is a Deviation?
Responsible for authorizing all master documents and SOP
Who is Quality Assurance?
Source information accessible and preserved in its original form
What is Original?
It is a requirement for an employee to report any communicable illness, disease, or injury that may affect product quality.
What is personal hygiene?
A written procedure and process that describes the actions to be taken if a change is proposed
What is a Change Control?
The documented act of demonstrating that any procedure, process, equipment, material, activity, or system will consistently lead to the expected results
What is Validation
The GMP reference under Health Canada GUI-001 for record keeping and good documentation practices.
What GMP reference C.02.020-C.02.024?
This individual must have university degree or equivalent and relevant practical experience.
Who is the head of quality department or manufacturing department?
The presence of a foreign material that makes a product, raw material, packaging component or bulk material unacceptable for use
What is Contamination?
Health Canada guidelines that aligns with other international GMP standards such as ICH, WHO, PIC/S, and etc
What is GUI-0001?