quality control Flashcards
what is the role of the pharmacist in a pharmaceutical industry?
-quality check
-research and development
-medical information
-clinical trails
regulatory affairs
why is pharmaceutical industry highly regulated?
- safety of patients
- has active pharmacological ingredients present
- can interact with fundamental physiological functions
- consequences can be severe
what is the tool used for risk assessment
FMEA -failure mode and effect analysis
- likehood
detectability
severity
who regulates the risks?
MHRA
- Regulatory bodies of the MHRA
what is quality control
aggregate of activities which are done to show an adequate quality of manufactured products
what test should be done as per BP- to check quality
UV-vis assay Propranolol (uniformity of content) Friability Disintegration Hardness (in-house) Uniformity of weight
QC in pharmaceutical industry
Raw Material Testing
API
Excipient
Packaging
In Process Testing (IPCs)
To determine if manufacturing step is complete
Finished Product Testing
To confirm specifications are met
what are the limitations of QC
- batch sampling size - only a small portion of sample can be tested
- impurities - cant test for every impurities
what is quality assurance
Total sum of the organised arrangements made with the objective of ensuring that products are of the quality required for their intended use
the maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.
what is cGMP
good manufacturing practice
- consistently produced and controlled according to quality standards
- minimise the risks involved in production
- cannot be eliminated through testing the final product
what are the requirements of GMP?
-quality management
-personnel
premises and equipment
-documentation
-production
-quality control
-compliant product recall
-self inspection
what is cGLP
good lab practice
reliable generation and verification of data and establish in confidence
what is the requirements for GLP
follow SOP
documentation and review
