BATCH ANALYTICAL REPORT

BATCH ANALYTICAL REPORT

AND
DATA INTEGRITY IMPROVEMENT

Jakarta 05 JUNE 2018

Speaker:
HERU PURNOMO
BATCH ANALYTICAL REPORT
Common Data Recording Deficiencies

• Non Contemporaneous data recording

• Post it usage

• Missing printout

• Lack of second verification/witness

• Focus on end data not the process sequence especially for dilution steps

• Improper review process (what and how to review by whom)

• Instrument traceability

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BATCH ANALYTICAL REPORT
Improper Practices in QC Lab

• Improper Testing Method reference (non updated version)

• Misalignment between registered method – validated method – actual use

(validated parameter did not use in actual routine/wrong column used)

• Senior info is more valid than written procedure/testing method

• Good QC result is the most appreciated

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BATCH ANALYTICAL REPORT
Common Audit Finding in QC Lab

Procedures do not accurately reflect current laboratory practice or contain

sufficient detail specific to the laboratory practice.
Procedure lack adequate information to perform the test method or lack sufficient
detail for a similarly trained individual to duplicate the task.
Procedures do not follow the current version of the published methods.
LOD and LOQ verification procedures have not been addressed in Quality System
documentation or verification practices implemented.
SOPs do not contain or reference all of the steps in the preparation of samples
and standards.
Method modifications and deviations from the standard method are not clearly
documented in the SOPs.
Changes to the method are not clearly described. Findings include undocumented
volume adjustments to standard and reagent preparations.

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BATCH ANALYTICAL REPORT
FDA Warning Letter 2017 – Data Integrity
https://www.pharmaceuticalo
nline.com/doc/an-analysis-
of-fda-warning-letters-on-
data-integrity-0003

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BATCH ANALYTICAL REPORT
For our thought

If product is manufactured according to

manufacturing/packaging instruction, why QC testing
is not performed in the same way?

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BATCH ANALYTICAL REPORT
Overview ALCOA++ Principle

Aspect Regulation Expectation

Attributable Who performed an action and when Unique IDs, Audit Trails

Legible Can the data file / written entries be Legible and meaningful data
read throughout the life cycle?
Contemporaneous and Documented at the time of the Time stamped; easy access to
Complete activity systems
All data/information complete No missing data/information
Original Original record or a certified copy Back up and archive systems
capture all data & meta data
Accurate No errors or editing without Procedures exist to control any
documented amendments amendments or re-processing
of data

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BATCH ANALYTICAL REPORT
Overview ALCOA++ Principle

Aspect Regulation Expectation

Secured & Controlled • Prohibit unauthorized access • Individual login IDs &
• Actions attributable to specific passwords
individual • Access level aligned to job
• Protected from accidental or role
deliberate changes • System access
management procedure
• Physical security controls
• Firewalls & controlled
remote access
• Documented control of
electronic signatures

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 BATCH ANALYTICAL REPORT
Overview ALCOA++ Principle

Aspect Regulation Expectation

Data Review • Second-person review of all • All GxP data identified

critical data • Critical data review procedure
• Data checked for accuracy • Audit trail review procedure
• Review of all data • Evidence of each review
• Routine • Data summaries verified against raw data
• Periodic
Data Retention • Original or true copies • Documented & validated archival &
• Integrity preserved (Maintained restoration process
from modification) • Backup copies verified as true copies
• Validated retention process • Data content preserved, including
• Readily available • Metadata
• Readable format • Audit Trails
• Configuration files
• Security & access controls
• Retention & disposal procedure

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Overview ALCOA++ Principle

Aspect Regulation Expectation

Validated System • User requirements & • Risk assessment in place

configuration defined • Data integrity principles included in design &
• Computer Inventory List tests
• Systems validated for intended • Operational procedures ensure data integrity
use maintained
• Change & configuration • Periodic reviews in validation schedules
management
• Operational & maintenance
procedures
• Periodic review

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

Batch Analytical Report will provide more detail instruction, and define critical
steps/parameter to check.

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

As it is specific BAR per batch, it become complete source of information how one
batch is tested according to updated testing method
In common
More detail instruction, minimize unclear instruction practices this
timing seldom to
be recorded

In its Testing Method

only spelled “until
YYY is dissolved”

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

These approaches fulfilled :

- Basic GDP Principle (Write the task to be performed, perform what’s
written, document what’s required)
- Attributable and Legible
- Detail review process is clear
- Contemporaneous
- Task is recorded and reviewed in time

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity
Double check at
Define verification step clearly per tested. the end of test
for Appearance
Check
Double check at step
by step process from
beginning to the end

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

These approaches fulfilled :

- Basic GDP Principle (Write the task to be performed, perform what’s
written, document what’s required)
- Attributable and Legible
- Detail review process is clear
- Contemporaneous
- Task is recorded and reviewed in time
- Quality Risk based approach on second review approach
- Critical test → more verification steps

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity
Has place to paste print out. Should it is round campaigned test, it is easy to refer
to, in one place

1 set of BAR contained tests according to official TS method. Test can spread to
few analysts to perform test. By having proper footnote/headnote and paginating it
helps to ensure all testing and result has been completely performed.
The header (printed every page) contained :
• Related batch
• Product Name/Product Code
• Reference Testing Method

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity
The footer (printed every page) contained :
• Printed time and date
• Page
Footer

Header

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

These approaches fulfilled :

- Basic GDP Principle (Write the task to be performed, perform what’s
written, document what’s required)
- Attributable and Legible
- Detail review process is clear
- Minimize potential missing receipts
- Minimize the usage of post it or other non-official data recording
- Contemporaneous and Complete
- Task is recorded and reviewed in time
- Potential of missing pages is minimized

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

These approaches fulfilled :

- Original
- With printed date and time → any reprocess, reprint form can be detected
- Accurate
- With defined review step any potential deficiencies on data can be immediately
detected
- Data Review
- Clear on data review process → review know what and how to review by whom
- Data Retention
- Transparent detail data and it is filed together with each batch record

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BATCH ANALYTICAL REPORT
How Batch Analytical Report can Improve Data Integrity

These approaches fulfilled :

- Validated System
- Batch analytical report is developed based on validated and registered method

- Quality Risk based approach on second review approach

- Critical test → more verification steps

Overall increase reliability and confident level of data

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BATCH ANALYTICAL REPORT
Remember

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BATCH ANALYTICAL REPORT
How the expectation on data has evolved

Data itself Creation Creation

Destruction Processing
Destruction Review

Retention
Review
& Retrieval
Retention &
Reporting
Retrieval
Reporting

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BATCH ANALYTICAL REPORT
How the expectation on data has evolved

Now is focus on data and data lifecycle

Data*) :
all original records and certified true copies of original records, including source data and
metadata and all subsequent transformations and reports of this data, recorded at the time of
the GxP activity and allow full and complete reconstruction and evaluation of the GxP activity.
Accurately recorded by permanent means at the time of the activity.
May be contained in paper records (such as worksheets and logbooks), electronic records
and audit trails, photographs, microfilm or microfiche, audio- or video-files or any other media
whereby information related to GxP activities is recorded.
*) WHO - GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES
Data lifecycle
All phases of the life of the data (including raw data) from initial generation and recording
through processing (including transformation or migration), use, data retention, archive /
retrieval and destruction”

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BATCH ANALYTICAL REPORT
How the expectation on data has evolved

Data alone is no longer sufficient

Focus change to what behind the data on its data life cycle
• All phases of the life of the data (including raw data) from initial generation and
recording through processing (including transformation or migration), use, data
retention, archive / retrieval and destruction”
• Current focus on data processing (latest PIC/S)
• HPLC printout is no longer accepted as raw data
• What it is inside the HPLC data is the raw data

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 ADDITIONAL KEY ASPECTS
Human Factor and Culture

TGA - Australia
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 QUALITY CULTURE

Strong system of internal controls to ensure data integrity

Managing human behavior
> Personal
> Organization

Included in company core’s value, code of ethics and proper conduct to assure the
reliability and completeness of data.
All employees should be trained on the code of ethics and conduct, and it should be
prominently displayed throughout the worksite
Transparent and open reporting of deviations, errors, omissions and aberrant
results at all levels of the organization, irrespective of hierarchy
Reporting mechanism independent of management hierarchy
Top down enforcement
Walk the talk

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BATCH ANALYTICAL REPORT
Summary

QC is critical area →provide data for batch disposition

Reliable, accuracies, precision, validity of data is important

Robust system and procedure are critical keys to increase confident

level of data

Finally, all system and procedure must be tied in together with

people and culture

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