Lecture 2: Quality Systems In NZ Hospital Pharmacy Flashcards
What are the quality systems?
Quality control
Quality improvement
Quality assurance
Good manufacturing practice
What is quality?
Always the result of : High level intention Sincere effort Intelligent direction Skillful execution
Quality is fitness for purpose
What is quality control?
The detection of defects.
Divided into actions and outcomes
What are the actions of quality control?
Sampling
Testing to specifications
Documentation of standard procedures
Compliance
What are the outcomes of quality control?
Starting materials Packaging materials Manufacturing environment Finished product pharmaceuticals Safe and fit for purpose
What is quality improvement?
The improvement of systems.
The purposeful change of a process to improve the reliability of achieving an outcome
What is the procedure of quality improvement?
Quality control detects a problem: the product is not fit for purpose.
Quality improvement corrects the problem using either a change in process and/or a change in materials to make the product fit for purpose again
What is quality assurance?
The prevention of defects
This is a wide ranging concept covering all matters which individually or collectively influence the quality of a product.
I.e. Good manufacturing practice
What does good manufacturing practice consist of?
GMP, cGMP, GLP, GPP
This is the part of quality assurance which ensures products are consistently produced and controlled to the quality standards appropriate to their intended use
What do quality systems focus on?
The product/service quality AND the means to achieve it,
It uses quality assurance and control of reprocesses as well as product testing to achieve a more consistent quality.
Why should quality be maintained?
Legal obligation Patient safety Consistent performance Operator safety Reputation Cost effectiveness
What is the history of quality systems in NZ?
the NZ GMP was updated in the early 1990s
-adapted from the PIC/S
(-evolved over the previous 50 years from international standard organisation)
What are the relevant parts of the NZ code of GMP for manufacture and distribution of therpeutic goods?
part 1: manufacture of pharmaceutical products (1993)
part2: manufacture of blood and blood products (1993)
part 3: compounding and dispensing (1993) part 3 annex 1: compounding of sterile pharmaceutical products (1995)
Part 4: wholesaling of medicines and medical devices
part5: uniform recall procedure for meidcines and medical devices (1995)
What causes compounding audits in NZ hospitals to fail?
- no controls
- no expiry
- no batch numbers
- insufficient documentation
this called for new standards
What is the NZ standard 8134.7:2010?
- forms part of the NZS 8134
- health and disabiltiy services standards
published on 1/04/2010
- supersedes previous codes of GMP
- incorporates PSNZ document “quality standards for pharmacy in NZ”