GMP DOCS Flashcards
What are the key requirements for completing GMP documentation correctly?
- A well designed and structured to prevent errors, where it is Clear, readable and inerasable
- avoid handwritten document , but if required allow for sufficient space for entries which are made at the time of action-›
- All significant actions recorded – traceable
- Changes to entries:
o – signed, dated and reason given
o – original entry should still be readable - › document must be regularly reviewed and kept up to date, only current documentation should be available.
- Approved, signed, dated by appropriate competent and authorized persons.
What are the main aims of the GMP documentation system?
to define specifications for all materials (raw materials, packaging and labelling materials, in process product and final products)
* › To define methods of manufacture and control
* › To ensure all personnel know exactly what to do and how to do it
* › To ensure all necessary information is available for decision making
* › To provide information- routinely and during investigations
* › As evidence of what was done
Explain the different types of GMP documents normally used in a pharmaceutical company. List the typical documents used in a GMP facility?
1) Site master file – GMP related activities of the manufacturer.
2) Specifications - requirements for what product/materials must conform to
3) SOP – give direction for performing certain operations
4) Technical agreement – agreement between contract givers and acceptors for outsourced activities
5) Records – evidence of various actions taken to demonstrate compliance with instruction
6) Certificate of analysis – summary of testing results on sample of product showing compliance to regulatory requirement or industry standard.
7) Logbook - activities related to use of equipment
Why is control of labels a GMP requirement?
- GMP rules require that products rules be correctly identified with the correct name, ingredients, strength, and batch information, which is critical to patient health.
- Prevents mix-up and cross-contamination.
Discuss the typical control and approval process for documentation in a GMP compliant facility.
control documentation overseen by QA, and may be subdivision of documentation department depends on size of company.
- QA last signature on all docs.
- Head of department signatures on most records signature appear on first page of documentation.
- Effective date stamped on each page
New [documents] should be [approved] and [dated] before being [issued]. [Effective] date should be [far] enough away to allow [training].
Old version
- stamped as superseded/ sign approvals to people who agreed on revision
- Don’t discard and add to file with QA/doc control.
No longer needed – stamped as obsolete and all copies removed from folder.
Discuss the typical control and approval process for documentation in a GMP compliant facility.
control documentation overseen by QA, and may be subdivision of documentation department depends on size of company.
- QA last signature on all docs.
- Head of department signatures on most records signature appear on first page of documentation.
- Effective date stamped on each page
New [documents] should be [approved] and [dated] before being [issued]. [Effective] date should be [far] enough away to allow [training].
Old version
- stamped as superseded/ sign approvals to people who agreed on revision
- Don’t discard and add to file with QA/doc control.
No longer needed – stamped as obsolete and all copies removed from folder.
What is cGMP
- Good manufacturing practice c is for current as the requirement changes and gets updated frequently. It is a legal requirement.
- Minimise risk in manufacturing process by using sound quality principles the manufacturer undertakes to ensure product have identity, strength, purity and quality that they must and claim to contain.
- quality and safety and efficacy of the product meet regulatory requirements.
importance of CGMP
Importance : because without it there is :
- high risk contaminated products
- medicine do not work, too strong, too weak or unstable
- incorrectly labelled medicine
- defective unit could kill a patient
- helps the consumer to trust the product and trust the manufacturer of the product
- provide high assurance that all medicine released legally on market are safe, pure effective, labelled and free from contamination.
importance of CGMP
Importance : because without it there is :
- high risk contaminated products
- medicine do not work, too strong, too weak or unstable
- incorrectly labelled medicine
- defective unit could kill a patient
- helps the consumer to trust the product and trust the manufacturer of the product
- provide high assurance that all medicine released legally on market are safe, pure effective, labelled and free from contamination.
