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PH3704- Pharmaceutical technology > QA- lec 8 > Flashcards

QA- lec 8 Flashcards

1
Q

What is an audit

A
  • A key tool in maintaining standards and quality improvements
  • A part of the overall QA system
  • Allows determination of compliance with
    • cGXP
    • Legal requirements
    • License commitments
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2
Q

Audit versus research

A
  • Some characteristics of the audit are similar to research, but the audit is not research
  • Research
    • Creates and tests a new hypotheses
  • Audit
    • Reviews standards to improve the quality of care
    • E.g. only giving certain anti-biotics for certain conditions- then checking those antibiotics are working well
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3
Q

The beginnings of Audit (1)

A
  • Government white paper
  • Working for patients 1989
  • An effective programme of the audit will help to provide, the necessary re-assurance to doctors, patients and managers that the best quality of service is being achieved within the recourses available
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4
Q

The beginning of Audit (2)

A
  • Moving towards Audit 1993
    • An education package for pharmacists
  • Pharmaceutical quality standards
    • Hospital self-assessment standards
  • Health Service Executive Letter
    • EL (96)95 and EL(97)52
    • Audit report form and checklist
    • Audit as the driving force to quality improvement
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5
Q

Pharmacy contract

A
  • Each community pharmacy needs to participate in at least 2 audits per year
  • Pharmaceutical journal 13 August
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6
Q

Audit

A
  • The audit is about taking notes of what we do, learning from it and changing if necessary
  • The audit should be a continuing process
  • Driving force to quality improvement
  • Started off as manufacturing
  • Moving to improve care/outcomes of patients
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7
Q

The Audit Cycle

A
  • Audit Planning and Design => Set standards
  • => Collect data
  • => Evaluate the performance =>
  • => Make changes
  • => Monitor the effects of change
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8
Q

Cycle audit planning and design

A
  • How to start
  • Topic
  • Audit design
  • How to finish- feedback about improvements and acheivments
    *
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9
Q

What topic to audit

A
  • High risk- Aseptic production
  • High-volume- Over labelling
  • Local issues- Needle exchange
  • Targets- repeat Rx’s
  • Area’s of concern- unique to place
  • Area’s using large resource- Chemotherapy
  • Pharmacy contract-
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10
Q

Topic examples- clinical Audit

A
  • New audit toolkits
    • Smoking cessation
  • Archive templates
    • Patient counselling audit
    • Repeat prescribing
    • Audit Protocol for advice on asthma device technique
  • Look as RPS site for more
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11
Q

Topic examples- Production Audit

A
  • Production processes
    • Documentation
    • Training
    • Environment
  • Orange guide chapters
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12
Q

Cycle: Set standards

A
  • Standards should be SMART
  • Specific
  • Measurable
  • Acheivable
  • Realistic
  • Timed
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13
Q

Stadards should also be

A
  • Driving force for improvement in standards of service and outcomes for patients
    • Best practise
    • Benchmark
  • Desirable
  • Agreed
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14
Q

Advice on asthma technique (MDI)

A
  • 60% wash the device according to manufacturers instructions
  • 90% Do not regularly test the device
  • 75% rinse their mouth after using an inhalation device for an inhaled steroid
  • 90% able to demonstrate how to use the device correctly
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15
Q

Repeat dispensing audit

A
  • Criteria and standards should reflect national and local targets and accepted by the team
  • These standards should then be agreed by the team
  • Agree suitable means of collecting this data
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16
Q

Repeat dispensing audit

A
  • This is a large topic- split into small sections and audit these areas
  • Functional
    • Who does what, when, how, time, checks
  • Administration
    • Documentation
  • Clinical
    • ADR reports, drug interactions, medication reviews, compliance, missing or ambiguous directions
  • Make sure you stick to smart targets
  • Requests for repeat prescriptions will be processed promptly
  • 90% of requests for repeat Rx’s will be processed within 24 hours of request
17
Q

Collect data

What is actually happening

A
  • Collect only the data required
    • Dont get carried away and collect to much data
    • Concentrate on answering the audit questions
  • Keep data collection as simple as possible
  • Make sure the time and place are suitable for participants
  • Allow time for questions and discussion
18
Q

Evaluate performance

A
  • Compare what should be and what is happening
  • Was the information complete and accurate
    • Was it all collected during busy periods
    • Did anything exceptional happen during the audit: Staff sickness; locum cover
19
Q

Make changes

A
  • Consider if standards have been met
  • Identify cause(s) of non-compliance
  • Agree on changes to be made
  • Ownership of the audit is vital
    • If practice change is required, participants must be able to see why otherwise committed to the changes will not occur
20
Q

Monitor effect of changes

A
  • This where the cycle continues
  • Evaluate the success of change
  • Re-measure the performance against standards
  • The audit cycle starts again
21
Q

Why Audit

A
  • Maintain standards
  • Benchmarking
  • Measurement of improvement
  • Sanity check
  • Identity weakness and strengths
  • Build confidence in QA systems
  • Assess risk to patients
22
Q

Why audit

A
  • Because it is required by GXP
  • Shows the regulators you meet appropriate standards
  • Improve standards of service (where appropriate)
  • Improve outcome for patients
  • Self-inspections should be conducted to monitor the implementation of GMP
  • Pharmacy contract
23
Q

Audit types summary

A
  • Third party
  • Second party
  • First party
  • Horizontal
  • Vertical
24
Q

Third party

Audit types

A
  • Undertaken by staff not managerially accountable within the corporate structure independent of any service provider to the unit
  • A regulatory Audit
  • For manufactures= MHRA
  • For pharmacies= GPHC
  • Can be commissioned by a company for a third party to audit a supplier or subcontractors
25
Q

Second party audit

Audit types

A
  • When a company perfoms an audit of a supplier to ensure that they are meeting the requirements specified in the contract
26
Q

First party Audit

Audit types

A
  • Internal self-inspection
  • Conducted in an independent and detailed way by designated competent persons from within the company
  • Monitors the implementation and compliance with GMP principles and to propose necessary corrective measures
27
Q

Audit approach

A
  • There are 2 general approaches to audit
  • Horizontal audit
    • Follow a process through- e.g. from raw material receipt, through production to finished product release
    • A good way to get a feel for the site and its problems
  • Vertical Audit
    • Focus deeper into a specific area or topic for example adverse incident, complaints recalls
    • Can be time-consuming
    • You need to know when to stop

PH3704- Pharmaceutical technology (22 decks)

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