Good Laboratory Practice (GLP) Philip Cunningham St Vincent s s Hospital Sydney

Transcription

1 Good Laboratory Practice (GLP) Philip Cunningham St Vincent s s Hospital Sydney

2 Pharmaceutical clinical trials may require research or non-routine routine laboratory test results for study endpoints Why? To provide a framework to quality assure laboratory activities

3 Quality management Technical requirements The audit (review) process

4 Accreditation standards ISO 9001:2000 (Quality Management Systems ISO (Calibration and testing medical testing) OECD GLP (Pharmaceutical manufacture)

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6 Elements that lead to improvements in the established policies and procedures Quality System Improvement Preventative action Corrective action Quality system establishment Organisation and management Quality system (includes documentation) Quality System Elements designed to ensure successful operations (technical elements) Quality Control System Document control Request, tender and contract review Sub-contracting of tests and calibrations Purchasing of services & supplies Elements that review and Generate opportunities For improvement Quality System Review Service to client Complaints Non-conformance control Internal audits Management review

7 Audit Evaluate competence of laboratory to provide the scope tests/services required Documented quality system Conformance to standard or QS Recommend improvements Constructive health check

8 Audit Evidence based Documentation Eyes, ears, nose, touch Must be verifiable

9 Types of Audits Advisory visit Initial assessment Reassessment scheduled surveillance visit Variation visit protocol change Follow-up assessment

10 Before the day Document review Audit what to expect On the day Team briefing lead auditor and team Opening meeting all staff Audit of technical competence of facility Audit of Quality management system Final team meeting Closing meeting

11 Staff training and competence Documented evidence of training Qualified Sufficient numbers of staff Adequate supervision and relief arrangements Understanding Authority signatory approval Organisational chart

12 Testing environment Relevant monitoring equipment Potential for contamination, interference is minimised Adequate lighting, ventilation Laboratory areas are fit for purpose Safety Security access, storage areas, archives Storage of consumables

13 Management of equipment Appropriate for purpose Operating correctly and maintained in good working order - calibrated Operating procedures Staff competence Safeguards against accidental adjustment Damaged equipment is isolated from use Significant equipment is maintained under schedule records kept

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20 Calibration and measurement traceability Critical equipment Initial calibration, recalibrations and performance checks are appropriate Performed by trained staff Appropriately documented Recorded accurately accepted/rejected Frequency - scheduled Traceability to national/international reference standards

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22 Method documentation & validation All methods are documented clearly in sufficient detail, suitable for new staff member Readily available Used by staff Document controlled Non-standard test methods acceptable to sponsor/client Records of validation are adequate Computerised systems validated

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24 Document control Formal mechanism to review, update, distribute and recall critical documents Only current versions are used Extracts from methods are controlled (eg( eg. flowchart) No unauthorised amendments or notes No obsolete methods in use Authorised

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27 Sampling and handling of test items Documented procedures available to staff at sampling locations Staff competent Sample identification is unique (2 forms) Identification is legible and permanent ID linked to records Criteria for unsuitability rejection System in place for receipt, registration, preparation and disposal Checks to prevent deterioration

28 Monitoring validity/reliability of results Participation in external quality assurance program (QAP) performance reviewed Corrective actions are carried out Internal monitoring Internal controls are appropriate Results reviewed Statistical analysis appropriate Corrective actions are taken

29 Records and reports Traceability of all steps collection to test results Data retention (15 years) - secure Legible Corrections are authorised and indicated Evidence of checking calculations and data transfers Variations to methods are clearly indicated Integrity and confidentiality maintained

30 Internal audits Schedule exists covers all components of QMS, tests, staff, documentation timeframes are appropriate Schedule adhered to Records of auditor training and independence of auditors retained Internal audit reports Corrective actions and timeframes

31 Management review Reviews scheduled at least annually Senior management involved Effective communication at all levels Records of discussions, meetings, outcomes, implementation plans Attendance at meetings recorded Absentees informed

32 Complaints, corrective and preventative action Records are kept of all complaints, non- adherence to policy, suggestions for improvement Responsibility defined for action root-cause of problems determined Timeframes of action appropriate Effectiveness of action determined

33 Audit report Compliance Observation Minor non-conformance (condition) Major non-conformance Time frame to complete corrective actions Written response