Gdp alcoa
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Transcript of Gdp alcoa
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?