GLP Deficiency Data - gov.uk · GLP Deficiency Data 2017 / 2018 Inspection Year Analysis (01 Apr...
Transcript of GLP Deficiency Data - gov.uk · GLP Deficiency Data 2017 / 2018 Inspection Year Analysis (01 Apr...
GLP Deficiency Data2017 / 2018 Inspection Year Analysis(01 Apr 2017 – 31 March 2018)
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Breakdown of GLP findings in 2017/18
16 critical findings were raised in the 2017/18 inspection year, broken down as follows:○ 1 was raised under the heading of ‘Computerised Systems’○ 1 was raised under the heading of ‘Organisation & Personnel’○ 5 were raised under the heading of ‘Quality Assurance’ ○ 9 were raised under the heading of ‘Study Conduct’
0 50 100 150 200 250 300 350 400 450
Deficiency
Major
Critical
Deficiency Major CriticalSeries1 469 65 16
Incidence of Deficiency
3
65 Inspection Majors in 2017/18
23
1
6
14
0
39
0
5
10
15
20
25
30
35
40
Archives Computerisedsystems
Facilities Organisation &Personnel
Quality Assurance SOP's Study Conduct
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% Breakdown of GLP Major Findings in 2017/18
Note: there were no major findings attributed to categories: SOPs
Archives3% Computerised systems
5%
Organisation & Personnel9%
Quality Assurance22%
Facilities 2%
Study Conduct, 60%
Archives
ComputerisedsystemsOrganisation &PersonnelQuality Assurance
SOP's
Study Conduct
5
Breakdown of 39 Study Conduct Majors in 2017/18
0 1 2 3 4 5 6
Acquired data not secure
Missing data
(Data Integrity) Other
Printouts insufficient to classify as raw data
incomplete review of data (i.e. not looking at audit trails)
Inappropriate access rights / No user permissions
(Data Integrity Controls) Other
Issues with method validation performance or documentation
Errors, omissions or discrepancies in the report
Compliance statement
QA statement
Errors, discrepancies in study data
Unable to reconstruct study activities / insufficient details recorded
Study plan
SD / PI not discharging duties
Amendments
Deviations
Multi-site aspects
(Study Management & Conduct) Other
6
Breakdown of 14 Quality Assurance Majors in 2017/18
0 1 2 3 4 5
Risk based QA issues / Management of QA programme
Process based audit programme
Study based / critical phase audit programme
Failure to comply with own procedures
Delay / failure to undertake corrective & preventative actions
Issues related to the inspection of QA
Quality Assurance (Other)
7
Breakdown of 12 additional Majors in 2017/18
0 1 2 3
Delays in Archiving
Inadequate or no validation
Equipment related - calibration
Conflict of Interest
(Organisation, Personnel, Delegation & Responsibilities) Other
Training (specific)
Training (GXP)
8
469 Inspection Deficiencies in 2017/18
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% Breakdown of GLP Deficiency Findings in 2017/18
Total: 469 Deficiencies
Archives9% Computerised systems
3%
Facilities10%
Organisation & Personnel
13%
Quality Assurance12%SOP's
12%
Study Conduct41%
Archives
ComputerisedsystemsFacilities
Organisation &PersonnelQuality Assurance
SOP's
Study Conduct
10
2017/18 Archiving Deficiencies
Total: 42 Deficiencies
0 2 4 6 8 10 12
Facilities
Procedures for archiving
Procedures for loans including extensive loan periods
Unable to locate archived records
Delays in archiving
Electronic archiving
Archiving (other)
11
2017/18 Computerised Systems Deficiencies
Total: 15 Deficiencies
0 1 2 3 4 5 6
Inadequate or no validation
Documentation – policies / SOPs / records
Documentation (reports) – delays in reports, report approvals
Change control
12
2017/18 Facilities Deficiencies
Total: 47 Deficiencies
‐1 1 3 5 7 9 11 13 15
General housekeeping
Equipment related – calibration
Equipment related – maintenance
Equipment related – other
Equipment related – fridge / freezer storage and monitoring
Doc control/storage ‐ methods,validation or calibration docs
Labelling / identification of samples / reagents /expired reagents etc
Facilities (other)
13
2017/18 Organisation & Personnel Deficiencies
Total: 63 Deficiencies
0 2 4 6 8 10 12 14
Organisation reporting lines
Job descriptions
Conflict of interest
Master Schedule
Organisation, Personnel, Delegation & Responsibilities (other)
Training (specific)
Training (GXP)
Documentation of training
14
2017/18 Quality Assurance Deficiencies
Total: 54 Deficiencies
0 2 4 6 8 10 12 14
Process based audit programme
Study based / critical phase audit programme
Facility based audit programme
Failure to comply with own procedures
Delay / failure to undertake corrective & preventative actions
QA related multisite study issues
Delays in reporting audits/inspections
Issues related to the inspection of QA
Quality Assurance (other)
15
2017/18 SOP Deficiencies
Total: 55 Deficiencies
0 5 10 15 20 25 30
SOP administration and control
SOP review
SOP content
Overdue SOP reviews
SOPs (other)
16
2017/18 Study Conduct Deficiencies
Total: 193 Deficiencies 0 5 10 15 20
Lack of SLA / contract
Contracts & Agreements (other)
Time stamp not secure
Data Integrity (other)
Incomplete review of data (i.e. not looking at audit trails)
Use of shared passwords / logins
Data Integrity Controls (other)
Failure to assess validation status of method
Errors, omissions or discrepancies in the report
QA statement
Reporting (other)
Problems with supporting records
Unable to attribute data to an individual
Source / Raw Data (other)
SD / PI not discharging duties
Deviations
Study Management & Conduct (other)
Test item expiry
Test item storage
Reference Item Issues
Record Keeping / Essential Documents (other)
Trend analysisInspection Year 2014/15 to Inspection Year 2017/18
18
Number of GLP Inspections 2014/15 – 2017/18
0
5
10
15
20
25
30
35
40
45
50
55
60
65
2014/2015 2015/2016 2016/2017 2017/2018
19
Trend Analysis of Critical Deficiencies 2014/15 - 2017/18
0
1
2
3
4
5
6
7
8
9
10
2014/15 2015/16 2016/17 2017/18
Archives Computerised Systems Facilities Organisation & Personnel Quality Assurance SOPs Study Conduct
20
Trend Analysis of Major Deficiencies 2014/15 - 2017/18
0
5
10
15
20
25
30
35
40
2014/15 2015/16 2016/17 2017/18
Num
ber R
aise
dArchives
ComputerisedSystemsFacilities
Organisation &PersonnelQuality Assurance
SOPs
Study Conduct
21
Trend Analysis of Deficiencies 2014/15 - 2017/18
-40
10
60
110
160
210
260
310
2014/15 2015/16 2016/17
Num
ber R
aise
d
ArchivesComputerised SystemsFacilities
Organisation & PersonnelQuality Assurance
SOPsStudy Conduct
22
Trend Analysis of All Deficiencies 2014/15 - 2017/18
0
100
200
300
400
500
600
700
800
2014/15 2015/16 2016/17 2017/18
Num
ber o
f Def
icie
ncie
s
Year
DeficiencyMajor
CriticalTotal
23
Trend Analysis of Major and Critical Deficiencies 2014/15 – 2017/18
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