good manufacturing practice Flashcards
1
Q
what is production?
A
- Part of Manufacture, focuses only on:
- Producing the actual medicine
- Collecting materials
- Making medicine
- Testing
- Packaging
2
Q
what is quality
A
Pharmaceutical quality is the foundation that allows patients to have confidence in the safety and efficacy of medicinal products.
3
Q
Quality control vs Quality Assurance
A
Quality control (QC):
Testing of products
* Tests in place
* IPQC testing
* Finished product testing
* Part of QA
Quality Assurance (QA)
* Systems in place
* Independent of testing
* Risk assessment
* QA= GMP
4
Q
GMP Definition
A
- Good manufacturing practice (GMP) is a system for ensuring that
products are consistently produced and controlled according to quality
standards. It is designed to minimize the risks involved in
any pharmaceutical production that cannot be eliminated through testing
the final product. - Involve both QA & QC
5
Q
Who sets these standards?
A
- Regulatory agencies: EMA, MHRA, FDA, ICH, PICS
6
Q
principles of gmp
A
- clearly defined and controlled process
- employee training of procedures
- investigate customer complaints
- corrective and preventive action
- well documented procedures
7
Q
Importance of GMP
standards
A
The main purpose is to prevent any
harm from occurring to the patient.
8
Q
Stages of audit
A
Pre – audit work
At the audit
Post – audit work
9
Q
manufacturing process
A
- dispensing
- addition of ingredients
- mixing
- homogenisation
- filling & capping
- labelling & packaging
10
Q
A
11
Q
A
