Good Documentation Practice (GDP)

1. Training On:
Good Documentation Practices (GDP)
MD. FARUK HOSSEN
Sr. Executive
Quality Assurance Department

2. Why GDP?
Good Documentation Practices (GDP) is required in order to ensure
an auditable account of work performed.
GDP is required for all documentations included in a fully developed
quality system.

3. What is Documentation ?
To Document each activity you perform, Documentation is a Process,
which comprises of Following : -
 Recording of Data
 Approval of Documents
 Issuance and Disposal of Documents
 Retrievability of Documents
 Presentation of Documents
 Review of Documents

4. What is Documentation ? (Cont.)
Good Documentation practice GDP "Right-first-time” approach for the
document is GDP to ensure identity, authenticity and accuracy of
records. If your Document says “What actions took place in the
development or manufacturing of product so that anyone, including
auditor or inspector has documented evidence that you did exactly what
you said ” that is GDP.

5. Types of the Documents
Commitment Documents : Relationship between industry and the
regulatory authorities Example : DGDA, USFDA, MHRA etc.
Directive Documents : Relationship between the Management and
Employees Example : Specifications, STPs, SOPs, MFCs etc.
Record Documents : Relationship between the Employees and the
Work they perform Example : Protocols, BMRs, Log Books,
Calibration Records etc.

6. Regulatory Requirements
 FDA Q7A Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, Section VI. Documentation and
Records
 ICH Good Manufacturing Practice Guide for API Q7, Section 6
Documentation and Records
 21CFR58 : Good laboratory practice, Subpart J.
 ISO 9001- 2008, Clause 4.2 : Documentation requirements
 Guide to GMP for Medicinal Products Part 1, Chapter 4
Documentation: PIC/S PE 009-8 (Part I)

7. Purpose of documentation
 Proof of fact
 Record
 Regulatory requirement
 Quality maintenance and improvement
 Control the processes (Resource optimization )
 “Your documentation is an advertisement for your work”
 End user requirements
 To improve performance
 Enables important messages to be communicated clearly and
accurately.

8. Documentation Life cycle
Document creation & Approval: - The process owner or the authorized
person should write as per the specific format and template and circulate
the document after getting approval of QA.
Document Use & Data Collection: - Responsibility of all technicians,
engineers, scientists, operating persons who are trained and authorized to
collect and record data.
Data Verification: - Responsibility of supervisors, managers and all
individuals trained & authorized to review data.
Record Review & Product Disposition / Approval: - Responsibility of
QA or those trained & authorized to review records

9. Documentation Life Cycle (Cont.)
Record Archiving:- Records are Accessible, Retrievable, Secured
is the responsibility of QA & relevant departments
Record Destruction: - As per SOPs that directs the destruction of
documents

10. Who Participates in Creating the Documents?
Everyone involved in the process or procedure
Managers
Team Leads
Staff doing the work or impacted by the work
Include ALL departments and divisions impacted
Consultants may assist

11. When?
During implementation of all new process, documentation is created
and procedure is tested by all impacted departments
During implementation of all change, documentation is reviewed,
process or procedure is updated, and tested by all impacted
departments
Annually, review all documentation to ensure it is accurate.
Periodic Review part of continuous process improvement cycle to
evaluate need for change

12. Where?
Documentation during Project Design
Documentation during Construction Phase
Documentation during Commissioning and start-up
Documentation during Qualification and Validations
Documentation during Commercial Production
Documentation during Testing and Release
Documentation for Regulatory submissions
Documentation beyond…………

13. Document Signatures
All documentation used to provide evidence that standards are being
followed must be signed and dated by authorized person as it adds
value to the document.
No signature pads, scanned signatures, or duplicated original signatures
shall be used to replace a handwritten signature by the person signing
Documents shall be signed in permanent ink.
Signatures shall be kept throughout the life of the document.
The local date shall be used to date documents.

14. Handwritten Entries
Adequate space is provided for expected handwritten entries
Handwritten entries are in indelible ink
Critical entries must be independently checked (second person verified)
No spaces for handwritten entries are left blank - if unused, they are
crossed out or "N/A" (or similar text) entered
Ditto marks or continuation lines are not acceptable
A stamp in lieu of a handwritten signature is not acceptable

15. Document Maintenance
Regularly reviewed and kept current version
Record for the creating, issuing and modification should be there
Retained and available for appropriate duration & in appropriate
condition
Electronic document management systems are validated
Electronic records are backed up

16. Document Modification
Handwritten modifications are signed and dated
Where appropriate, the reason for alteration must be noted ("E.E." is a
common abbreviated reason, indicating "Entry Error")
Controls exist to prevent the inadvertent use of superseded documents
Electronic versions can only be modified by authorized personnel and
controlled by password or other means
A history must be maintained of changes and deletions to electronic
versions as well as paper documents.
Uncontrolled changes can have a substantial impact on a company's
ability to demonstrate compliance

17. Corrections/Additions In Record
Single line through the information that needs to be corrected.
All corrections or additions shall be signed and dated.
Should not to scribble out the original data, use white out or write over
data .
In Document Only personnel who have already been approved to write
or make changes to document can correct or add to documents.
Typographical error change or additions do not require approval.

18. Document Review
Responsibility of Supervisors, Managers and all individuals trained &
authorized to review documents and data at specific time interval.
An approved list of Designees, Originators, and Reviewers shall be
maintained.
If a Designee is to be used, then that person signs his/her name, adds the
words “signing for,” and adds the original printed name of the approver.
Designees must have the knowledge, skills, and abilities to perform the
assigned authorship, verification, or approval activity.

19. Typical Elements of a Documentation System
 Logo
 Title
 Doc. No
 Effective date
 Revision
 Page no
 Signature
 Format
 Stamp

20. Document Numbering
All document shall have a unique document number.
This is typically issued by a document control department or person
(Quality Assurance).

21. Date & Time
A legal date is comprised of a month, day, and year, although not
necessarily in that order. Local conventions are assumed unless otherwise
specified in an SOP.
It should be in uniform format. For example : DD/MM/YY
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 (AM/PM) shall be defined

22. Document Effective Date
Date of the change or the date from which the document become live.
Effective date changes on every new change in the document. And
each change should be recorded at change history at the front page of
the document “Document Review Date”.
Date given to the document after the respective departmental head
review the document in consultation with actual user.
And after approval all the master and controlled copies are stamped as
“REVIEWED” on the document with review and next review date.

23. Document Revision
All documents shall have a revision level & latest document should
live.
Two type of the revision:
Routine revision : - No technical or editorial modification but at the
end of the two years of the effective date. - HOD will review and if
there is no any change then HOD shall send internal communication
that this document doesn't need revision. - If yes then Review the
document and stamped as “REVIEWED” - Valid only twice then
document is revised as per DCC procedure.
Technical or editorial revision : This type of the revision shall be
carried out by Document change control procedure and recorded.

24. 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.
Regulatory Approval

25. ALCOA Expectations
Attributable
 Who created a record and when?
 Who amended a record, when and why?
 That last one, the “why” (the reason for change) is an important
area in which there are frequently gaps. It is always best to
explain why an entry is being changed
Legible
 Common sense requirement

26. ALCOA Expectations (Cont.)
Contemporaneous
All signatures/ initials must be accompanied by date that
indicates when the signature/initials were appended.
Related to their method of evaluation of data
 Original
Records are expected to be original; this is a basic scientific
principle
Not to use scratch paper, post-Sticks or any uncontrolled
notebook in a GMP area.

27. ALCOA Expectations
Accurate
Honesty is first consideration here and thoroughness is the
second. Make sure of the information that you are recording
is correct and make sure you are telling the “whole truth”.
Regulatory inspectors are highly trained to detect fraud.
There’s a very fine line between fudging a result and
outright fraud.
“Transparency is a good thing …in
fact it is one of the key goals of
ALCOA”

28. ALCOA Plus:
C= Complete, C= Consistence, E= Enduring, A= Available
Complete
To ensure nothing has been deleted or lost
Consistence
The data has a date and time stamp that is in the
expected sequence.
Enduring
Data must be preserve for long time.
Available
The data must be available for reviewing at any time
written the storage of data.