This document provides information on good documentation practices (GDP) for pharmaceutical manufacturing. It discusses how documentation is crucial for quality assurance and aims to ensure manufacturing processes are carried out consistently as planned. It defines key terms like documents, records, data reliability and integrity. The document outlines good practices for documentation like contemporaneous recording, error correction procedures, and preventing issues like falsification. It provides examples of documentation deficiencies from inspections and consequences of poor practices like warning letters. Maintaining ALCOA principles of documentation - being Attributable, Legible, Contemporaneous, Original and Accurate - is emphasized. Case studies on meningitis and salmonella outbreaks show how documentation lapses can have severe public health impacts.

1. M. Phaneendra Reddy
Quality Assurance
Lazuline Biotech Pvt Ltd
GOOD
DOCUMENTATION
PRACTICES

2. If it wasn’t documented,
It was’t done!
Document what is done as well as
what is not done!
-TGA & FDA

3. Documentation
• Documentation is a crucial part of the quality assurance system and is
needed in almost every aspect of pharmaceutical manufacturing .
• It aims to provide high degree of assurance that the manufacturing
process or quality related activities are carried out in the similar manner as
they are planned and approved
• It provides procedures or the detailed information regarding the process
of manufacturing to the personnel's concerned with manufacturing and
ensures that the personnel's know what to do and when to do.

4. Document
An approved instruction either in paper or
electronic form which guides about how an
activity shall be executed.

5. Record
A record is often considered as document.
Records provide evidence that activities have been
performed or results have been achieved.

6. A document can be a procedure, specification, drawing, work
instruction and the record is also a document with the
difference that it provides evidence of compliance with
established requirements and effectiveness of the operation
of QMS.
Document Vs Record

7. What is Good Documentation Practice?
Good Documentation Practices (GDP) are methods for
recording, correcting and managing data, documents and
records, to ensure the reliability and integrity of
information and data throughout all aspects of a product's
lifecycle.

8. Data Reliability is the degree to which a collection
of data is complete, consistent and accurate throughout
its data lifecycle.
DATA RELIABILITY

9. What is data integrity?

10. • Generating, transforming, maintaining and
assuring the accuracy, completeness and
consistency of data over its entire life cycle
in compliance with applicable regulations.
• Applies to paper and electronic data and records,
within the scope of a quality management system
DATA INTEGRITY

11. Concept not new, but “Data Integrity has been and currently is a major
global concern of Health Authorities and the pharmaceutical industry.”
• 2016: 80% of FDA warning letters issued had Data Integrity deficiencies
• Jan 2015: MHRA issued Data Integrity Guidance for GMP
• March 2016: ISPE includes special report on data integrity in magazine
• April 2016: FDA issues Draft Guidance on Data Integrity
• June 2016: WHO issued final Guidance on Good Record and Data
Management Practices
• July 2016: MHRA new Draft Data Integrity Guidance to include GxP
• Aug 2016: EMA issued Q&A on Data Integrity
• Aug 2016: PIC/S issued Draft Guidance on Data Integrity

13. Not recording
activities
contemporaneously.
Backdating Fabricating data
Copying existing
data as new data
Re-running samples Discarding data
Releasing failing
product
Not saving electronic or
hard copy data (old
communications not saved)

14. Observations on poor
documentation practices
Document error correction
Write- over
Audit trail not documented
SOP not authorized by QA
The delegation for the batch release in case of
absence of the QA manager not recorded/documented
Out-of-specification (OOS) procedure not detailed
enough

16. How are mistakes corrected?
• Draw a single line through the error
• Make the correction next to the error
• Write an explanation for the error
• Sign and date the correction.

17. Date & Time
• It should be in uniform format.
DD-MM-YYYY
• Postdating (entering a date of the future) is not permitted
• Backdating (entering a date on a day after the entry was made or
the task was performed) is not permitted
• If times are required, procedures identifying approved guidelines
for documenting date and time (24 hr) shall be defined.
• Time format should be in HH:MM

18. If any page(s), lines, columns are left blank, draw a line
across the page from left top to right bottom of the
page and write “CANCELLED” / “N.A.” (Not applicable)
across the page and sign with the date.

19. •Loss Of Trust
•Form-483
•Warning Letter
•Import Alert
•Recalls
•Non compliance report
•Notice of concern
•Loss of Job
•Loss of Business
•Loss of money

20. Barriers
• Human Errors –
 When data is entered by mistake
 Not being aware of regulatory requirement or poor training
 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

21. What are the precautions we have to take???

23.  ALCOA 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”
ALCOA

25. ATTRIBUTABLE
It should be clear -
Who When Why has documented the Data?
Who When Why created record / changed
record?
• All data entries shall be dated on the date of
entry & signed or initialed by the person
entering the data.

26. LEGIBLE
• The record created, especially the paper-based
records should be legible. This is very important in
the Pharmaceutical industry as a mistaken
spelling could result in the administering of a
completely different drug. The records should be
permanent and not erasable so that they are
reliable throughout the data lifecycle.
• "Data shall be recorded directly, promptly and
legibly in ink."

27. CONTEMPORANEOUS
• Contemporaneous means that the records
should be created at the time of taking the
measurements. This includes having time and
date stamps on the data and prohibits
backdating of data.
• This is done so that continuity is maintained and
the results can be viewed with respect to time
whenever required.
• Data shall be recorded directly, promptly and
legibly.

28. ORIGINAL
The data should be original in the sense that the
medium it is first recorded in should be preserved
throughout the lifecycle of the product. For example,
if the data is first collected on paper forms and then
digitized, then the paper forms should be kept for the
entire lifecycle of the product.

29. • The recorded data should be accurate, free
from errors and biases. No editing should be
done on it without making notes of such edits.
For example, witness checks are used for
critical data collection.
• Study must be conducted in accordance
with the protocol.
• Test systems to be monitored in conformity with
the protocol.

30. Attributable
Who acquired
the data or
performed an
action and
when was it
acquired?
Legible
Data must be
in a legible
format and
permanent
during the
entire
retention
time.
Contemporan
eous
Documented
at the time of
the activity.
Original
Raw data or
source data
must be
available in
original
form or true
copy.
Accurate
Data must
contain
context/
meaning and
metadata.
ALCOA

31. Benefits of good documentation
• Unlock the potential of individual using the document
• Amplify the value of your product
• Build confidence in your quality
• Good Documentation helps to save the papers
• Reduce the efforts to compliance with regulatory bodies
• Good documentation enables to achieve the results that you are seeking for.

32. New England Compounding: Meningitis Outbreak
2012
• Pharmacy technicians instructed to prioritize production over cleaning and
disinfecting
• Pharmacy technicians instructed to falsify cleaning records, showing rooms
were properly cleaned when they had not been
• Neglected to investigate contamination found in the clean rooms
• Company distributed orders even though they were still waiting for sterility
test results
• “As alleged in the indictment, these employees knew they were producing
their medication in an unsafe manner and in insanitary conditions, and
authorized it to be shipped out anyway, with fatal results,” said Attorney
General Eric Holder
64 reported deaths, >800 patients sickened President
sentenced to 9 years in prison Other employees charged with
multiple criminal acts Led to passage of Compounding
Quality Act providing increased FDA oversight

33. Peanut Corporation of America: Salmonella Outbreak 2008-
09
• In some cases, company officials falsified lab results, stating peanut
products were safe to eat when tests showed otherwise, or when products
had never been tested at all, according to court papers. - The Wall Street
Journal
• The company shipped product with falsified Certificates of Analysis (COA),
which attested to the purity of contaminated lots
• CEO wrote in a March 2007 email to a plant manager about contaminated
products: "Just ship it. I cannot afford to lose another customer."
9 reported deaths, >700 consumers sickened CEO sentenced to 28 years in
prison; others sent to prison including Plant Quality Manager Loss of nearly $1
billion in peanut sales Plant closed & company liquidated

34. DATAFULFILL α DATAACCEPTABLE

35. ASK YOURSELF THESE QUESTIONS
Who am I?
What am I doing?
What are my values?
What might go wrong ?
What is the likelihood it will go wrong ?
What are the consequences ?

36. Thank you !