Good Documentation

Practices

QUALITY ASSURANCE
 Contents
1. Why good documentation is essential?
2. What constitutes good documentation?
3. Purpose of Document System
4. Document System Basic
5. What is Documentation?
6. Good Documentation Practices
7. Essential Characteristics
8. Documentation Lifecycle
9. Where Documentation
10.Types of Documents
11.Good Documents Requirement
12.Strenghts of Good Documents
13.Observations in Poor documents
14.How are mistakes corrected?
15.Tips for good documentation
16.Learnings
 Why Good Documentation is
essential?
An essential part of the quality assurance system
and should exist for all aspects of GMP
(reference: WHO GMP, Volume 2)

Good documentation practice is an expected

practice!

Correct, complete, current, and consistent

information effectively meet customer and
stakeholder' requirements

Helps to reduce observations raised on

inadequate documentation practices.
 What constitutes Good
Documentation?
Approve, review and update documents

Changes & current revision status of documents

identified

Relevant versions of applicable documents

available at points of use

Documents remain legible and readily identifiable

Documents of external origin identified and their

distribution controlled

Prevent unintended use of obsolete documents,

and archiving.
 PURPOSE OF DOCUMENT
SYSTEM
Each manufacturer shall establish effective
quality system, instructions and procedures
in accordance with the requirements of this
part and maintain the established quality
system instructions and procedures
effectively.
No matter what type of product is developed
and produced, it must be safe, effective and
fit for its intended use.
Quality characteristics are established in
documents.
Documents declare product standards and
describe how to monitor, test and judge for
compliance with these standards.
 DOCUMENT SYSTEM
BASICS
A document system is an interacting set
of documents, each with a defined
purpose and consistent document.
The documents can:
Assure that quality standards are
consistently met
Communicate these standards to all who
interact with product
Interact in a manner that reduce
redundancy and increase the flexibility of
the system when changes occur
 What is Documentation ?
To Document each Activity you perform

No, Documentation is a Process, Which comprises

of Following :
- Recording of Data
- Review of Documents
- Approval of Documents
- Issuance and Disposal of Documents
- Retrievability of Documents
- Presentation of Documents
Good Documentation Practices
Just creating documents is not enough; you must follow
specific standards when doing so. Following established
practices allows everyone who reads your documentation to
understand exactly what you mean.
Key documents with the potential to impact product quality
must be retained to provide a traceable, historical record of
all activities. Documentation must be readily retrievable in
order to meet requirements associated with product
investigations, periodic product review, or formal audits
It is necessary to document anything that directly impacts a
product. Record every procedure you write, form you fill out,
and test you perform. Using a standard format eliminates
discrepancies between documents from different sources.
 ESSENTIAL CHARACTERISTICS
To design an effective & efficient documentation process first
identify the important characteristics of processing event.
The document directing the manufacturing event
fulfills current regulatory commitments to the
agency; it is appropriately written, reviewed and
approved
The directive document is appropriate for the task to
be performed
The data is authentic; the individual responsible for
performing the work has entered the data on an
appropriate data collection document
The data is accurate
The data is complete. There is no missing
information, and there is no work as yet uncompleted
that will impact the occurrence of the data presented.
 ESSENTIAL CHARACTERISTICS
The data is legible, consistently recorded and
trustworthy
The data collected fulfills expectations (specifications)
The data is accessible to those who need to review it,
audit it or use it to perform trending analysis.
The original data and the original documents
(manufacturing record) is retrievable for review or
audit
The original manufacturing record is secure
Proper control of documentation also requires that
responsibility for each processing step to be assigned
All documentation should be legible, clean, readily
identifiable, retrievable and maintained in facilities
that provide a suitable environment to minimize
deterioration or damage and to prevent loss
 DOCUMENTATION LIFE CYCLE
Document creation, Review Approval: -
Authorized document review and approval
signatures are responsible for directing the
manufacturing, the security, original, approved
documents is the responsibility 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
 DOCUMENTATION LIFE CYCLE
Record Achieving:-
Records are Accessible, Retrievable, Secure is
the responsibility of QA & relevant
departments
Record Destruction: -
As per SOPs that directs the destruction of
documents
Every signature associated with documents
review & approval, data collection and record
review and approval should add value to the
document. Every one who signs a document
or a record should know what their signature
means. Only those individuals trained and
authorized to sign documents should sign
them.
 WHY DOCUMENTATION ?

Cost for Good

Documentation

Cost for Poor/No

Documentation

THEREFORE, DOCUMENTATION BRINGS BUSINESS

 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...
 Types of Documents
There are three types of Documents

Commitment Documents : Relationship

between industry and the regulatory
authorities
Directive Documents : Relationship
between the Management and Employees
Record Documents : Relationship
between the Employees and the Work
they perform
 Some Examples are :
Commitment Documents : Quality
Manual, Site Master Fileetc.
Directive Documents : Specifications,
STPs, SOPs, MPRs etc.
Record Documents : Protocols, BPRs, Log
Books, Calibration Records etc.
 What Good Documentation
requires :
CLARITY - they should not be open to
misinterpretation by the users. They should
be written in a way that makes them easy to
check, particularly when they will form part
of a product manufacturing history.

Good documentation design will help to

minimize errors
 What Good Documentation
requires :
REGULAR REVIEW AND UPDATE -
documents must be kept up-to-date with
changes in regulations or processes and
should be distributed in a controlled manner
to ensure that only the most recent versions
are available for use. They must also be
available to those who need them, where
they need them!
 What Good Documentation
requires :
FORMAL PRESENTATION - controlled
documents should be prepared in accordance
with a written procedure, now a days
probably using a computerised
documentation control system.
 What Good Documentation
requires :
Records should be made at the time of
each action - do not rely on memory for their
completion.
Records relating to manufacturing or testing
operations should be kept for at least one
year after their expiry.
 What Good Documentation
requires :
If documents or data are stored
electronically, the computer system must be
validated to assure data security and
integrity.
Provisions must also be made to retrieve the
stored data, possibly years after they have
been generated:
 Strengths of Good
Documentation
Clear Objective of the document
Clarity of Scope
Who should prepare ? Should know ?

Layout of the document in mind

Put pieces together
Explain the activity performed logically
Use short, simple, easy to understand
sentences
 Strengths of Good
Documentation
Maintain flow of script
Match script to the sequence of events of
the activity
Use correct data format
Meaningful data will give meaningful
information
Draw neat and correct inference
Conclusion & Summary
Get your document edited by an expert
 Observations on poor
documentation practices
Document error correction not signed/dated, and didnt
include a reason for the correction

Write-overs, multiple line-through and use of "White-out"

or other masking device

Sample sequence table and audit trail not documented (if

its not documented, it didnt happen)

SOP related to production, calibration, storage and

maintenance not authorized by the QA head

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;

flow chart and /or check-list not available.
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.

 Following is a list of concerns when
designing documented processing control: -
When documents or records are transferred from
one department to another or from one building
to another the transfer should be recorded
When documents or records are waiting to be
processed, they should always be stored in
designated location. Apply the same principles to
the security of documents during review process
Critical processing steps should be checked
include document issue, data collection,
document review. More review signatures on a
document does not necessarily result in a more
through review
 Records must always be completely
identified and this identity should be
consistent and easily available.
Every page of every document should be
consistently labeled with the document
identification number/ code, the document
revision number/code, the product
identification number / code and product
lot number.
Every signature associated with document
review and approval should add value to
the document
Every one who signs a document or
record should know what their signatures
means
 Only those individuals trained and
authorized to sign documents should sign
them
It remains a challenge in normal systems
to know who is trained and authorized to
sign what document

Note: - This is a fundamental quality

assurance requirement for the processing
of documents

Databases should be qualified or validated

There should be procedure in place to
direct the data entry process
Some tips on Good Documentation
Practices
Records should be completed at time of activity or when
any action is taken

Superseded documents should be retained for a specific

period of time

Records should be retained for at least one year after the

expiry date of the finished product

Concise, legible, accurate and traceable

Picture is worth a thousand words

Clear examples

Dont assume knowledge.

 Tips of Good Documentation
Errors in manual entries in various documents shall
be rectified in blue ink as follows :
Wrongly mentioned as 77.80
76.80
Weight of filled cylinder with EO+CO2 gas in kg= 77.80 20/06/2016

.
 Learnings.
Good Documentation Practices should be
everyones concern.
Foundation of a sound documentation
system begins with the engineering
documents as well as their management.
Engineering is the provider
Production is the customer
QA is the gatekeeper.
Validation is the hold-up and
Everyone just wants to pass the
baton.
 Learning
More the better is not the right dogma
More entries we make, the greater
the opportunity for error.
But, if we reduce the documentation,
we may omit critical and vital data.
Any activity becomes creative, if the Doer
cares about doing it right or better.
Each Activity is a forward Certification
if performed with proper perspective and
documented in a right way.
 Always to remember
Truly, documentation is our Business, and
to remain profitable, we should forget the
syndrome We can fix the documentation
later ........
Any Questions???

Thanks