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By
Deepak Mishra
Scope
What is Data Integrity…???
Regulatory Requirements for Data integrity
Recent Regulatory Changes
Comman Data integrit...
What is Data Integrity…???
Generating, transforming, maintaining & assuring the
accuracy, completeness & consistency of th...
GMP Regulatory Requirements for Data
Integrity (21 CFR 211 Regulations 3) (Contd.)
Instrument must be qualified & fit for ...
GMP Regulatory Requirements for Data
Integrity (21 CFR 211 Regulations 3) (Contd.)
Methods must be verified under actual c...
Recent Regulatory Changes (Contd.)
Three Regulatory changes on Data integrity in
regulatory laboratories :
A complete res...
Recent Regulatory Changes
EU Monitoring the records of activities and specifically
mentions hybrid and fully electronic s...
Hybrid System
Hybrid system - an environment consisting of both
Electronic & paper-based Records (frequently
characterized...
Comman Data Integrity Issues (contd.)
Comman Passwords : Not possible to identify who
creates or changes the data/records...
Comman Data Integrity Issues (contd.)
Processing methods : Integration process not
controlled & also no defined procedure ...
Comman Data Integrity Issues
Incomplete Data : Most comman data integrity issue.
Record not complete.
Computer System Cont...
Process Flow Mapping in Data Integrity
Process Flow Mapping – A useful approach to focus on
electronic data for ensuring t...
Process
Flow
How
Actions
performed
How
Actions
recorded
Decisions
about the
action
Extent of
Manual or
Automated
process
R...
Criteria for Data Integrity (contd.)
Widely Used Term “ALCOA”.
First used by Stan Woolen to help him remember
compliance t...
8/15/2014 15
A Attributable Who performed the action & when ? If
record is changed, who did it & why?
Who did it ?
Source ...
Data integrity Citations in warning letters (contd.)
Sun Pharmaceuticals Industries Ltd, Gujarat
(November 2013).
 Failur...
Data integrity Citations in warning letters (contd.)
Wockhardt Limited , Aurangabad (March, 2013).
Presence of torn raw d...
Data integrity Citations in warning letters (contd.)
USV Limited, Mumbai (June 2013)
 Failed to follow and document at th...
Data integrity Citations in warning letters (contd.)
Fresenius Kabi (January 2013, Kalyani)
Unofficial testing of samples...
Data integrity Citations in warning letters (contd.)
Apotex Pharmachem India (January 2014, Bangalore)
Failure to maintai...
Maintaining the Data Integrity
Including Data verification activities in internal audits.
Creating Awareness among the sta...
Summary
Data
Integrity
Compliance
Competitive
Advantage
8/15/2014 22
Always better to have Proactive
approach than Remedia...
8/15/2014 23
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Ensuring data integrity in pharmaceutical environment

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Data Integrity related regulatory requirements, current Data integrity approach of Pharmaceutical industries, ALCOA+ Approach.

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Ensuring data integrity in pharmaceutical environment

  1. 1. By Deepak Mishra
  2. 2. Scope What is Data Integrity…??? Regulatory Requirements for Data integrity Recent Regulatory Changes Comman Data integrity Issues Process flow mapping in Data integrity Criteria for Data integrity Data Integrity Citations in Warning Letters 8/15/2014 2
  3. 3. What is Data Integrity…??? Generating, transforming, maintaining & assuring the accuracy, completeness & consistency of the data over its entire life cycle in compliance with applicable regulatory requirements. ICH Q10 Pharmaceutical Quality System defines the associated life cycle processes. 8/15/2014 3
  4. 4. GMP Regulatory Requirements for Data Integrity (21 CFR 211 Regulations 3) (Contd.) Instrument must be qualified & fit for the purpose (§211.160(b) ,§211.63). Software must be validated (§211.63). Any calculation must be verified (§211.68(b)). Data generated in an analysis must be backed up (§211.68(b)). Reagents & Reference solutions to be prepared with appropriate records (§211.194(c)). 8/15/2014 4
  5. 5. GMP Regulatory Requirements for Data Integrity (21 CFR 211 Regulations 3) (Contd.) Methods must be verified under actual condition of use (§211.194(a)(2)). Test data must be accurate & complete & follow procedures (§211.194(a)). Data & reportable value must be checked by second individual to ensure accuracy, completeness & conformance with procedures (§211.194(a)(8)). Methods used must be documented & approved (§211.160(a)). 8/15/2014 5
  6. 6. Recent Regulatory Changes (Contd.) Three Regulatory changes on Data integrity in regulatory laboratories : A complete response from a company to all 483 observations within 15 business days. Conducting Part 11 audits alongside normal GMP inspections of companies. 21 CFR Part 11 is the guidance on “ Electronic Records; Electronic Signatures – Scope & Applications”. 8/15/2014 6
  7. 7. Recent Regulatory Changes EU Monitoring the records of activities and specifically mentions hybrid and fully electronic systems. New EU GMP regulations for computerized systems (Annex 11) and documentation (Chapter 4) released in January 2011 and become effective on June 30, 2011. 8/15/2014 7
  8. 8. Hybrid System Hybrid system - an environment consisting of both Electronic & paper-based Records (frequently characterized by handwritten signatures Executed on paper). An example of hybrid system is the one in which the system user generates an electronic record using a computer based system & then is required to sign that record as per GMP,GLP OR GCP REQUIREMENTS. 8/15/2014 8
  9. 9. Comman Data Integrity Issues (contd.) Comman Passwords : Not possible to identify who creates or changes the data/records when analysts share passwords. User Privileges : No defined or segregated user levels for modifications of methods/sequences and integration. 8/15/2014 9
  10. 10. Comman Data Integrity Issues (contd.) Processing methods : Integration process not controlled & also no defined procedure of Integration. Regulatory bodies more concerned over the re- integration of chromatograms. Audit Trails : Audit trail functionality turned off within the system. As a result, impossible to trace who/when modified the data & why. 8/15/2014 10
  11. 11. Comman Data Integrity Issues Incomplete Data : Most comman data integrity issue. Record not complete. Computer System Control : No adequate control over data & unauthorized access to modify, delete or not saving electronic files and hence, may not be original, accurate or complete. 8/15/2014 11
  12. 12. Process Flow Mapping in Data Integrity Process Flow Mapping – A useful approach to focus on electronic data for ensuring the Data integrity. Map the workflow within the Laboratory, to identify & list all the steps performed for each Analytical Technique (from sample receipt to approval of results) & each laboratory operations. 8/15/2014 12
  13. 13. Process Flow How Actions performed How Actions recorded Decisions about the action Extent of Manual or Automated process Risk associated What Actions Performed 8/15/2014 13
  14. 14. Criteria for Data Integrity (contd.) Widely Used Term “ALCOA”. First used by Stan Woolen to help him remember compliance terms relevant to Data Quality. Sometimes referred as “ALCOA+” because they involve additional terms based on European Medicines Agency’s (EMA) concept on Electronic Data. 8/15/2014 14
  15. 15. 8/15/2014 15 A Attributable Who performed the action & when ? If record is changed, who did it & why? Who did it ? Source Data L Legible Data must be recorded permanently in durable medium and be readable Can you read it ? Permanent recorded C Contemporaneous Data should be recorded at the time work performed Was it done in real time..? O Original Is the information an original record or certified true copy..?? Is it original or true copy..? A Accurate No error or editing performed without documented amendments Is it accurate ? Complete All data including repeat or reanalysis performed on the sample 21 CFR 211.194 Consistent Consistent application on data time stamps in expected sequence Date /time stamps Enduring Recorded on controlled worksheets, laboratory notebooks or media . Medium used to record data Available Available/accessible for review/audit for the lifetime of the record For the lifetime of the record
  16. 16. Data integrity Citations in warning letters (contd.) Sun Pharmaceuticals Industries Ltd, Gujarat (November 2013).  Failure to include complete Data necessary to document he analysis.  Failure to assign or identify raw materials with a distinctive code, batch & to identify the disposition of materials.  Calibration records found torn.  CAPA records found to be torn used to assign the extended due date of ongoing CAPA.  Numerous raw data files on HPLC & GC instruments found to be deleted on computers used to operate the instruments.  Testing of samples no. of times for passing the batches of product. 8/15/2014 16
  17. 17. Data integrity Citations in warning letters (contd.) Wockhardt Limited , Aurangabad (March, 2013). Presence of torn raw data records of calibration, stability protocols in waste area. Incomplete HPLC & GC data. Facility of deletion of Raw Data files from hard drive. No record & justification of any deviations from required Quality control mechanisms. Incomplete training record of Personnel. 8/15/2014 17
  18. 18. Data integrity Citations in warning letters (contd.) USV Limited, Mumbai (June 2013)  Failed to follow and document at the time of performance required laboratory control mechanism (21 CFR §211.160(a)). Sample weight prints found in backdated.  Failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in controlled records & other documents.  Disabled Audit Trails on GC, HPLC & other software operated instruments .  Shared Login Ids between QC personnel of instruments like GC, HPLC.  Lacks assurance for the periodic backup of the data & failure to ensure that audit trails will not be disrupted in future. 8/15/2014 18
  19. 19. Data integrity Citations in warning letters (contd.) Fresenius Kabi (January 2013, Kalyani) Unofficial testing of samples as Trail, demo etc & not reporting those results. No investigation for OOS samples observed & also no adequate procedure of investigation . Facility of Unauthorized changes or deletion on controlled electronic records. Analysis of samples with “Testing into Compliance” approach. 8/15/2014 19
  20. 20. Data integrity Citations in warning letters (contd.) Apotex Pharmachem India (January 2014, Bangalore) Failure to maintain the complete data from all laboratory tests. Testing of samples with “Testing into complaince” approach. Failure to document & investigate OOS results. Failure to include adequate documentation during complaint investigations. Failure to record the analytical activities at the time they were performed. 8/15/2014 20
  21. 21. Maintaining the Data Integrity Including Data verification activities in internal audits. Creating Awareness among the staff about the data integrity importance. Train internal auditors what & how to check the data integrity deficiencies. Incorporating data integrity assessments into their Quality Assurance Programs. 8/15/2014 21
  22. 22. Summary Data Integrity Compliance Competitive Advantage 8/15/2014 22 Always better to have Proactive approach than Remedial Approach
  23. 23. 8/15/2014 23

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