GLP Deficiency Data - gov.uk · GLP Deficiency Data 2017 / 2018 Inspection Year Analysis (01 Apr 2017 –31 March 2018) 2 Breakdown of GLP findings in 2017/18 16 critical findings

GLP Deficiency Data2017 / 2018 Inspection Year Analysis(01 Apr 2017 – 31 March 2018)

2

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

4

% 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

9

% 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


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


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


‐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


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


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


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

24

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