Compliance in Food Testing and ensuring data integrity ... · 21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing Packing or Holding of Human Food 21 CFR Part 820

Compliance in Food Testing and ensuring data integrity – audit trail and its compliance

Dr. Anoop A. Krishnan

Assistant Director (Technical)

Export Inspection Council

(Export Inspection Agency- Kolkata laboratory)

16-Nov-16 International Workshop and training program on GFLP

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Contents of presentation

Introduction

Compliance in food testing

Data integrity

Audit trail

Requirement

Responsibility

Conclusion

International Workshop and training program on GFLP

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16-Nov-16

Introduction

Role of Testing laboratory

upgrading to meet global demands

adopting latest technology, improvising & developing new methods

to provide accurate and reliable results

To entrust the confidence to regulatory bodies and consumer

Role of Regulatory agencies

Establish, maintain and monitor the compliance & integrity

To ensure to provide confidence to consumers


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Compliance in food testing

Compliance means?

Compliance with!!

Need of Compliance!!


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Data integrity

Definition: Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle.

Data integrity refers to the overall completeness, accuracy and consistency of data. This can be indicated by the absence of alteration between two instances or between two updates of a data record, meaning data is intact and unchanged.


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Data integrity

Principle-ALCOA

Attributable

Legible

Contemporaneous

Original or true copy

Accurate


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Data integrity – not a new concept! Principles from the paper and ink era still apply

Data integrity requires

Data are exact and complete, and secure from alteration, inadvertent erasures or loss

Certain activities be documented at the time of performance

True copies or other accurate reproductions of the original records

Complete information, complete data derived from all tests, complete record of all data and complete records of all tests performed


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Intent of data integrity ensure data is recorded exactly as intended and upon

later retrieval ensure data integrity

ensure the data is the same as it was when it was originally recorded

Any unintended changes to data as the result of a storage, retrieval or processing operation, including malicious intent, unexpected hardware failure, and human error, is failure of data integrity

Changes should be noted, reasoned and non repudiated


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Data Integrity type

Physical data

Electronic data


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Data integrity problem The following are some examples of data integrity problems that have been

previously observed:

Reporting data for samples which are not analyzed ("dry labbing")

Falsifying existing data

Selective use of QC data

Overwriting files

Peak shaving, juicing (peak enhancing), deleting

Off-record spiking of samples to artificially increase potency

Time travel (changing times and dates)

Data that is "too good to be true eg. 100% recovery.

Discrepancies between electronic data and paper raw data.

Dates which do not match (e.g. dates of chromatograms do not match those being claimed as analysis date)

Integration parameters that are not traceable or retrievable. Laboratories are not be able to demonstrate that same results can be obtained when integration parameters are re-entered.

Delaying, denying or hiding data 16-Nov-16

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Data integrity- Regulated Available regulations

21 CFR Part 11 – Electronic Records, Electronic signatures

21 CFR Part 211 - Current Good Manufacturing Practice for Pharmaceutical Products

21 CFR Part 58 - Current Good Laboratory Practice for Pharmaceutical Products

21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing Packing or Holding of Human Food

21 CFR Part 820 – Quality System Regulation for Medical Devices

European Annex 11: Electronic Records;

Though data integrity – audit trail are integral part of ISO/IEC 17025: 2005, there is need to have elaborated guidelines and regulations to implement & maintain the same with respect to Food Testing laboratories


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Audit trail

Definition: Chronological record of system actions that is sufficient to reconstruct, review and examine an operation.

An audit trail is a chronology of the who, what, when, and why of a record.

For example, the audit trail for a HPLC run could include the user name, date/time of the run, the integration parameters used, and details of a reprocessing, if any, including change justification for the reprocessing.

Procedures and practices must be in place within the laboratory to verify the accuracy of manually entered and electronically transferred data collected on automated systems.


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Audit trail

Was the equipment functioning properly? Who performed the work, what was the date, and what specific parameters did they use?

What was there a problem? How was the problem fixed?


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Audit trails- Good practices

When data in the system/record are changed after each initial entry:

An audit trail must exist that indicates the new value entered

The old value, not to be erased or made illegible

A reason for the change

The date of the change

The person who entered the change, ideally the originator

The audit trail should show the changes that have been made to the results and display a record of who made those changes and when those changes where made with appropriate reasons/justification


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Audit trails- Good practices


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Question:

What happens if you make a mistake?

Answer:

Do not obscure original data!! Instead, draw a single strikeout, then add reason code, initials, and date of change. (Preserve the original data).

Why are Audit Trails important?

An audit trail is made to verify that the information contained in a final report is accurate and reflected by the raw data

An audit trail should show the entire history of a sample,

from the time of sampling, sample receipt and booked in, the records of critical activities which affect the results, the details of the test results and the source of the results right through to the details of who signed the lab reports.


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Requirements as per ISO/IEC 17025: 2005


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18 Requirement- Documentation

If you didn’t write it down, it NEVER happened. (As far as an auditor is concerned…)‏

Auditor/ Inspector

Requirement- GLP

GLP principles are a good idea even if you are not required to comply with the regulations.

• Say What You Do (with written standard operating procedures)‏

• Do What You Say (follow the procedures)‏

• Be Able to Prove It (with good record keeping)‏


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Responsibilities- MAN

Who is responsible to maintain & improve

Compliance

Data integrity

Audit trails


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Conclusion – How to ensure

Compliance

By fulfilling the requirements of ISO/IEC 17025: 2005

By continual improvement of effectiveness of quality management system

By monitoring & providing evidence of quality assurance through QC, PT or ILC

By identifying the training needs and training effectiveness

By implementing GOOD LABORATORY PRACTICES

Data integrity – Audit trails

By establishing, implementing & monitoring as per defined procedure

By defining responsibilities & authorization of activities

By providing software/system/procedure to record each activity with necessary details (e.g. Laboratory Information Management System or validated software)

16-Nov-16

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MAKE SURE THIS HOT TOPIC DOESN’T BURN YOU

Conclusion – How to ensure

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Thank you for your kind attention!

any questions?


23 Email: [email protected]

www.eicindia.gov.in

mailto:[email protected]



Documents

Compliance in Food Testing and ensuring data integrity ... · 21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing Packing or Holding of Human Food 21 CFR Part 820