08/28/2021

Data Integrity in Microbiology

Laboratory

Presented By:-Robit Siddiki

Executive
Quality Assurance
1 Tirupati life sciences pvt. Ltd.

Robit Siddiki, Tirupati Lifesciences Pvt. Ltd .

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Agenda

Useful Sources of Information

Define “DATA”
ALCOA+++ Principles
Regulatory Expectations
Data Integrity Risks
Tools for Assessing Risk

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Useful Sources of Information

 Food and Drug Administration (FDA)

– Data integrity and Compliance with cGMP Guidance for Industry,
April 2016
 Europeans Medicines Agency
– Data Integrity (Aug2016) Draft
 Medicines & Health Products Regulatory Agency
– MHRA GxP Data Integrity Definitions and guidance for Industry
(Jul2016) Draft
 Parenteral Drug Association (PDA)
– Elements of a Code of Conduct for Data Integrity

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o World Health organization (WHO) Annex 5

– Guidance on good data and record management practices

o PDA Book Assuring Data Integrity for the Life Sciences

o Pharmaceutical Inspection Convention (PIC/S) Draft

guidance 2016

o Good Practices for Data Management in Regulated

GMP/GDP Environments.

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Recent Publications
– Data Integrity Issues in Microbial Testing
• Cheryl Platco and Anthony Cundell, authors
• American Pharmaceutical Review, Sep/Oct2017

– Microbiological Test Data-Assuring Data Integrity

• Edward Charles Tidswell & Tim Sandle, authors
• PDA Journal of Science and Technology, 2017

– What is Data Integrity?

• Anil K. Rattan, author
• PDA Journal of Science and Technology, 2017

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What is Data Integrity

 The extent to which ALL DATA ARE COMPLETE,CONSISTENT, AND

ACCURATE.

 The data describe objective and factual status of all data values
throughout the data lifecycle.

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ALCOA principles:
 Attributable: Traceable to a Unique Individual
 Legible: Readable, Traceable Change, Permanent
 Contemporaneous: Activities Recorded at the
Time they occur
 Original: First Capture of the Data
 Accurate: Represents the actual conditions / data /
information

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ALCOA Plus (?)

 ALCOA Plus principles: Data are
– Enduring
–Available
–Accessible
–Complete
–Credible

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Some Definitions

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Why the recent Interest

 Increasingly observed violations in cGMP for data integrity
during inspections
 Resulted in warning letters, import alerts, consent decrees
– Requirement that backup data are exact and complete, secure
from alteration, inadvertent erasures or loss
– Requirement that data be stored to prevent deterioration or loss

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Cont.……

– Requirement that activities be documented at the time of

performance and lab controls are scientifically sound.
– Requirement that records be retained as original, true copies, or
other accurate reproductions of original records
– Requirement for complete information, complete data derived
from all tests, complete record of all data, and complete record of
all tests performed.

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What is the Lack of Data integrity?

 Many of the Pharmaceutical/Nutraceutical industry are
confused by the concept of data integrity.
 Data integrity is comprised of these following broad action to
hide test failure.
 Omission of data
 Error in data recording
 Changing data
 Deleting data
 Destroying data

These action may be both unintentional and intentional, representing GMP

violation that have civil and criminal consequences to the company and seriously
damage the company business.

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Data Integrity directed toward

microbiological testing
 The norm for microbiological testing is the visual
inspection of media for the detection of microbial
growth or the enumeration of microbial count.
 Typically the results are recorded on paper
worksheet or more recently into electronic
notebook.

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Cont.……
 The data, But not always the original microbial culture, are
checked by second person for completeness and the absence
of recording and arithmetical error.
 Contributing factors to reduce data integrity in the
microbiology laboratory are the subjectivity of scoring
microbial growth in broth, analyst to analyst variability in
counting colonies on plates and the ability to perform aseptic
manipulation with the contemporaneous recording of data.

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Cont.……
 Microbiological data has historically been evaluated and
recorded manually by appropriately educated and
experienced microbiologist trained in the art of
contamination detection and colony counting.
 Microbiologist must use experience, expertise and judgement
for test interoperation which may lead to subjective and
variable interpretation and documentation of test results.

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Microbiology Data Integrity Risks

 High Risk
– Analyst records incorrect data
– No second opinion results for subjective interpretation of results
– Analyst performs wrong method or wrong sample preparation
– Missed critical data or incorrect information
– Falsification or lack of authentic data due to uncontrolled lab
worksheets

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Cont.……

 Medium Risk

– Real time data entry difficult

– Incomplete data entries

– Chain of custody for samples not real time.

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Cont.……

 Low Risk

– Improper recording of non-critical data

– Real time entry of non-critical data (lot numbers, etc.)

not performed in timely manner

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Application of ALCOA Principles to

Microbiological data integrity issue

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Basic Risk Management/Assessment Tools

 The Pharmaceutical industry and regulators can assess and
manage the risks by using recognized management tools.
Below is the non-exhaustive list of some of the tools.
 Failure Mode Effects Analysis [FMEA]
 Failure Mode, Effects and Criticality Analysis [FMECA]
 Fault Tree Analysis [FTA]
 Hazard Analysis and Critical Control Points [HACCP]
 Hazard Operability Analysis [HAZOP]
 Preliminary Hazard Analysis [PHA]

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FMEA Severity Rating adapted for

microbiology QC testing
 Product quality not affected or insignificant
 Product quality not affected, unlikely to be noticed.
 Product quality not affected, and does not cause patient harm.
 Product quality may be affected, does not cause patient harm, but may
reduce product quality.
 Product quality may be affected, potential to cause minor patient
annoyance, but may cause
noticeable product quality attribute issues.

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Cont..
Product quality affected, potential to cause minor patient annoyance, complaints may be

filed.

Product quality affected, complaints are likely, patient harm or dissatisfaction may occur.

Product quality compromised, complaints and recalls likely occur, patient safety issues occur

with minor affects due to contamination or spoilage.

Product quality compromised, complaints and recalls occur, patient safety issues occur with

moderate affects due to contamination or spoilage.

Product quality severely compromised, spoilage and contamination visible, and/or patient

affects significant.

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FMEA Risk Assessment continues

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FMEA Risk Assessment continues

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Risk Mitigation

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Cont…

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Robit Siddiki, Tirupati Lifesciences Pvt. Ltd .

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Robit Siddiki, Tirupati Lifesciences Pvt. Ltd .

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Thank You!
Robit Siddiki, Tirupati Lifesciences Pvt. Ltd .