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”
What are the contents of the NZ standard 8134.7?
- consumer rights
- organisational management
- continuum of service delivery
- safe and appropriate environment
- dispensing, compounding, repackaging and batch preparation
- aseptic dispensing of sterile products in community pharmacies
- aseptic dispensing of sterile products in hospital pharmacies
What is the relationship between risk and location for the preparation of sterile products in hospitals?
the risks is highest when sterile products are prepared on the wards
What does the delivery of optimal pharmacy service depend on?
both the competence of the pharamcist providing the service
and the quality of the system through which that service is delivered
What does the content of 7.: aseptic dispensing of sterile products in hospital pharmacies mean?
this was adopted from the PIC/S PE 010-3
-guide to good practices for the prep of medicinal products in healthcare establishments
What are the contents of PE 010-3?
quality assurance system personnel work contracted out quality control documentation complaints and product recalls premises and equipment production self audits
What are the 2 annexes of PE 010-3?
annex 1: guidelines on standards for the sterile preparation of medicinal products
annex 2: guidelines on the standards required for the preparation of non-sterile liquids, creams and ointments
What does annex 1 invovle?
personnel,
documentation
premises and equipment (clothing and cleaning)
sterile processes (prep of terminally sterilised products, sterilisation by moist heat, aseptic processing)
quality control (monitoring, classification at rest, environment monitoring in operation, test limits for monitoring)
What are the requirements of personnel?
- relevant knowledge and experience in perparation of sterile products and microbiology
- appropriately trained and competencies assessed
- fully aware of consequences of any deviation from validated processes
- regular assessments
- knowledge of clean room technology
What are the requirements of premises and equipment?
- dedicated clear areas
- four classifications (A, B, C, D)
- airlocks
- hand washing facilities
- SOPs
- handling environments
- handling and filling performed in grade A environment in a laminar air flow cabinet
- Room to have a positive pressure (10-15Pa) and be grade B
- negative pressure used for hazardous pharmaceuticals (grade D)
- facilities to be dedicated and monitored
What are the different premises classifications?
A: <1 micro contamination per air sample
B: 10 micro contamination per air sample
C: 100 micro contamination per air sample
D: 200 micro contamination per air sample
What are the requirements for clothing?
- appropriate
- no outdoor clothing
- reatled to specific grades (D: hair, arms and shoes, A/B: head totally enclosed, facemask worn, footwear, suit with cuffs.)
- edicated to clean area
- visual inspections and monitoring
What are the requirements for cleaning?
- regularly cleaned
- personnel trained and assessed
- dedicated equipment and specific agents used
- effectiveness of cleaning demonstrated
What are the requirements for monitoring?
- performed to obtain evidence that process, operators and facility are operating under control
- tests carried out on commissioning of clean area, following changes or maintenance, routinely
-two types of monitoring: physical and microbiological
What is physical monitoring?
- set inhouse standards and action limits
- monitor trends
- results documented and retained
e. g. pressure differentials between rooms and within the work station are monitored daily before start of work
particle counts monitored quarterly
What is microbiolgoical monitoring?
-plays vital role in confirming that product is unlikely to be contaminated
-many products used before results are known
(the first indication is pyrexia or septicaemia in patient
frequent monitoring and reporting of results is important)
e.g. settle plates, glove prints in the direct work zone are monitored every working session and at end of each session, in the background they are monitored weekly and at the end of each session.
surface samples in the direct working zone are monitored weekly, and monitored monthly if they are in the background.
What are the different types of audits?
internal or self audit by a responsible person
external audit by a regulatory authority such as medsafe
audits examine all aspects of quality systems to ensure conformity with regulations or SOPs
Who maintains quality systems?
the quality control person or unit.
What are the responsibilities of the QC unit or person?
- prepare, issue and update SOPs
- prepare, issue and update master batch recrods
- ensure validation and maintenance of department equipment
- approval/rejection of starting materials
- ensures training and validation of staff
- evaluation of batch records/trends
- drafts reports where necessary
What are the results of audits?
- okay if all systems working well
- documentation, trend results, validation and training all contribute to audits
- out of specifications ‘incidents’ may happen - to be filled out on an incident form
What happens if incidents occur?
in reality, this occurs in varying degrees
- there is unlikely to be a designated QC person
- no QC labs or testing
but there will be hospital audits
- SOP, master batch sheets, records must be kept
- trends are analysed to determine who is responsible
