GMP Basics
This acronym refers to the current Good Manufacturing Practices followed in industry
What is cGMP
The golden rule of GMPs explains why documentation is important.
What is "If it isn't documented, it didn't happen".
This Quality System Enhancement was implemented in August 2025
What is Veeva Deviations?
This term refers to the system and the department that ensures quality standards are met, often involves release
What is Quality Assurance (QA)
The "L" in ALCOA stands for this to ensure documentation is understandable and clear.
What is Legible?
Date is to be written in this format to ensure clarity.
What is Alphanumerical
Training on GMP procedures, ensuring employees know their roles
GMP Training (Training)
This action is avoided to ensure that documents are completed in real time
What is back dating
To avoid Major and Critical observation in future audits we must create a site that is this.
What is Audit Ready
Designing and development of a product to ensure consistent quality from the time of development to commercial
What Quality Design (QbD)
This must never be done to effective documents
What is hand written comments or changes
The 2025 Self Inspection yielded repeated Minor Findings in this particular area.
What is Procedural Updates
This action provides documented proof that a process, system or equipment performs as intended
What is Validation?
This ALCOA principle discusses the assurance that recorded data does not lose readability or acessibility
Documentation errors must be avoided as the can primarily lead to this critical issue.