Objectives

Acquire basic knowledge of Good Documentation Practices

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.

What
is Documentation ?
To Document each Activity you perform having
one No, 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

Good
Documentation
Good Documentation practice GDP "Right-firstPractices
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.

The
purpose
of
Proof of
fact
Record
documentation
Regulatory requirement.
Quality maintenance and improvement (Better

risk management and robust quality systems).

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.

FDA statement should drilled into you from day one

If you didnt document it, then it didnt happen.

On one hand do the work, On other make the
How
to acquire GDP ?
document.
Use indelible (water-resistant) blue or black ink.
Never use White ink to remove error
Do not use pencil or felt-tipped marker.
Never overwrite or Scribbled the entry. Just single
cut the error with sign and date.
Never leave space or blank in the document and
Draw a diagonal line through any blank fields or
empty spaces at the bottom of a page and include
N/A along with your initials and date.

What are the Common Document Error

Missing signature and dates at the time the activity

is performed.
The write over and the scribbler.
Non uniform date and signature entry.
Data entries that do not correspond to the batch
record instructions.
Writing a note that activity was performed on one
day and signed for on other day.
Blanks on batch production records.
Pre-recording of data.
Incomplete references.
Review but not signed.
Illegible writing and too many corrections.

Why Documentation ?
Cost for Good Documentation.

Cost for Poor/No Documentation.

Incompleteness of document
Document which doesnt has sign and date of the
approval consider as the incomplete document.
All documents shall be signed by the originator.
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.
Specimen Signatures shall be kept throughout the
life of the document.
The local date shall be used to date documents.

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

Record Archiving:-

Records are Accessible, Retrievable, Secure is the

responsibility of QA & relevant departments.

Record Destruction: - As per SOPs that directs the

destruction of documents

Creating the Documents?

During implementation, all New Process

or documentation is created and

Procedure tested by all impacted
departments.
All Change to an existing documentation
is reviewed, Process or Procedure
updated, and tested by all impacted
departments.
Annually, review all documentation to
ensure it is accurate. Use as Periodic
Review part of continuous process
improvement cycle to evaluate need for
change.

Where documentation ?
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

GDP standards Document creation

Contemporaneous with the event they describe.
When electronically produced, the documentation

must be checked for accuracy.

Free from errors.
For some types of data, the documentation must be

in a format that permits trend evaluation Document

approval.
Approved, signed, and dated by appropriate

authorized personnel.

GDP guidelines
For Handwritten entries adequate space is to be 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 .
If electronic signatures are used on documents, they should be

authenticated and secure.

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.
Non-typographical error corrections or additions
Corrections/Additions
indicating a change IninRecord
data or acceptance status
require a comment.
Typographical error is routed through full document
Change control. Document Creation and Change
Request form.

Attributes of a good document

10 attributes of a good document
o Accurate
o Clear
o Complete
o Consistent
o Indelible
o Legible
o Timely
o Direct
o Authentic
o Authorized