ALCOAGOOD DOCUMENTATION PRACTICE

By: Shruti KargutkarJr. Officer Regulatory AffairsInventia Healthcare Pvt Ltd

If it wasn’t documented, It was’t done!

Document what is done as well as what is not done!

-TGA & FDA

INTRODUCTIONALCOA was coined by Stan Woollen in the

early 1990’s.1999 FDA Guidance: ALCOA - “To be

acceptable the data [from clinical trials] should meet certain fundamental elements of quality whether collected or recorded electronically or on paper. Data should be Attributable, Legible, Contemporaneous, Original, and Accurate”

DATA INTEGRITY Generating, transforming, maintaining

and assuring the accuracy, completeness and consistency of data over its entire life cycle in compliance

with applicable regulations.

DATA INTEGRITY ISSUES ?Undermines the Safety and Efficacy and/or

assurance of quality of the drugs Break trust

What Regulators see?Not recording activities contemporaneously.BackdatingFabricating dataCopying existing data as new dataRe-running samplesDiscarding dataReleasing failing productNot saving electronic or hard copy data (old

communications not saved)

BrazilMalaysia

IndonesiaVietnam

PhilippinesFrance

SpainItaly

GermanyKorea Republic(South)

JapanUnited Kingdom

ThailandTaiwan

Hong KongIndia

CanadaMexico

China

0 10 20 30 40 50 60 70 80

Number of warning letters

Countrywise warning letters

Why are document standards important?

Good documentation practice is an expected practice !

Correct, complete, current and consistent information

Reduce observations raised on inadequate documentation practices.

What constitutes Good Documentation?

Approve, review, update documentsChanges and current revision status of documentsRelevant versions of applicable documents

available at point of use.Documents remain legible and identifiable.Documents of external origin identified and their

distribution controlled.Prevent use of obsolete documents and archivingPassword protected and IT controlled signatures

Observations on poor documentation practices

Document error correctionWrite- overAudit trail not documentedSOP not authorized by QAThe delegation for the batch release in case of

absence of the QA manager not recorded/documented

Out-of-specification (OOS) procedure not detailed enough

Consequences of Data Integrity•Loss Of Trust•Form-483•Warning Letter•Import Alert•Recalls•Seizure•Non compliance report•Notice of concern•Loss of Job•Loss of Business•Loss of money

1. What might go wrong ?2. What is the likelihood it will go wrong ?3. What are the consequences ?

THINK ON YOUR OWN

WHILE FILING PATENT APPLICATIONS - SOURCED /ORIGINAL DATA - ALL DATA RELATED TO PATENT

TO TAKE CREDIT FOR WHAT WE DO, WE HAVE TO DOCUMENT IT.

DATA FULFILL α DATA ACCEPTABLE

Barriers • Human Errors –1. When data is entered by mistake11. Not being aware of regulatory requirement or poor training111. Willfully (falsification or fraud with the intent to deceive)• Selection of good or passing results to replace that are poor

or failing• Unauthorized changes to data• Errors while transmitting data from one computer to another• Changes to data through software bugs or malware of which

user is not aware• Hardware malfunctions such as Disc Crashes• Changes in technology where one item is replaced when it

becomes obsolete or no longer supported., making old records unreadable or inaccessible.

• Shortage of system space for archival of legacy data

CFR - Code of Federal Regulations Title 21

CFR Title 21- Food and Drugs : Parts 1 to 1499

Part 11 – Electronic records , Electronic signatures

Part 58 – GLP for Nonclinical Laboratory Studies

ALCOA

ATTRIBUTABLEIt should be clear -Who When Why has documented the

Data?Who When Why created record / changed

record? The requirement for attribution of data to the individual who collected it is found in 21 CFR 58.130 (e) According to the regulation, ‘’ all data entries shall be dated on the date of entry & signed or initialed by the person entering the data.

LEGIBLEReadable Data and Identifiable signaturesThough legible, it should not interfere with

other principles

21 CFR 58.130 (e) addresses directly by requiring that ‘’ Data shall be recorded directly, promptly and legibly in ink.’’

CONTEMPORANEOUSAs ObservedExisting at or occurring in the same period of timeOriginating / Existing/ Happening during same

period

21 CFR 58. 130 (e) ….. Data shall be recorded directly, promptly and legibly.

ORIGINALThe first record made by an appropriate person

The terms source data or raw data embody this concept of the first recording of data, and are sometimes used interchangeably.

Source data is the term generally used in the context of good clinical practices (GCP)

While GLP enthusiast use the term Raw data as it is officially defined in the GLP regulations at 21 CFR 58.3 (k)

ACCURATEAccurate, consistent and real presentation of factsAn accurate diagnosis / free from errorConforming exactly to truth or to standard

21 CFR 58.130 (a) requires that a study must be conducted in accordance with the protocol.21 CFR 58.130 (b) requires test systems to be monitored in conformity with the protocol.

ASK YOURSELF THESE QUESTIONSWho am I?What am I doing?What are my values?

References

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRPBoard Certified Internal Medicine and Pharmaceutical MedicineDRUG STUDY INSTITUTE

Data Integrity Issues : Causes and Solutions By Elayne Best, Biogen Idec , Mar,30,2015

The Compass- summer 2010 – Newsletter of the Southern Regional Chapter Society or Quality Assurance

WIPO – World Intellectual Property Organization (www.wipo.int)

ReferencesRegulatory Handbook : Data Integrity : FDA

AND GLOBAL REGULATORY GUIDANCE By Siegfried Schmitt, Principal Consultant, Parexel Consulting

Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application

https://www.youtube.com/watch?v=GgtdqMXNbC4

GOOD DOCUMENTATION BRINGS PEACE OF MIND

Thank you !

Any Questions?