GMP, GDP & GLP

Question 1

What are some requirements for GMP testing?

Answer 1

• Tests must be performed in accordance with documented, approved test methods.
• Tests must be validated or qualified, as applicable.
• The number/amount of sample(s) designated for testing should be sufficient to perform.
• OOS and questionable results must be investigated.
• The Quality Unit should review and approve all GMP test reports.

Question 2

Is all lab testing during the life cycle of DP regulated under GLPs?

Answer 2

No,
safety and safety/functional studies should be performed under GLPs,
while release testing of marketed products should be performed under GMPs.

Question 3

Why are document standards important in a GMP environment?

Answer 3

To ensure product quality and product safety, and poor documentation can potentially reduce patient safety.
Documentation provides both information on when, where, who, why and how to complete tasks, and evidence proving that the tasks have been completed as they should be.

Question 4

What are some different types of documents and records in a GMP environment?

Answer 4

Batch Record Forms,
Specifications,
Policies,
Protocols,
Standard Operating Procedures (SOPs),
Work Instructions (WIs),
Test Methods,

Question 5

6. What are some general GDP requirements for written documentation?

Answer 5

Documentation should be clearly written, accurate, and ensure no errors and consistency.
* Traceability between two or more documents/records should be ensured using formal document numbers or record identification.
* Indelible ink should be used for long-term legibility (no pencil).
* Legible handwritten entries should be made at the time the tasks are performed, signed, and dated.
* Documents and records should be reviewed by someone who did not perform the task, and staff signatures should be unique and recorded in a site signature register.
* Electronic signatures should meet the same general documentation requirements.