1. The document discusses good documentation practices for quality assurance and quality systems. It outlines the key elements of quality systems and 10 commandments for good manufacturing practices. 2. It defines key quality terms like GxP, defines what a document is, and explains the regulatory expectations around documentation being concise, legible, accurate and traceable. 3. The document emphasizes that documentation is important for demonstrating regulatory compliance, avoiding observations, and ensuring safe and effective medicines are produced. It provides guidance on fundamental document types, practices for document control, and the importance of high quality documentation.

1. 1
Good Documentation Practices

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Quality Assurance
The sum total of organized
arrangements made with the
object of ensuring that
products are of the quality
required for their intended
use and that quality systems
are maintained.

3. 3
Quality System- 8 essential element
Management
principle
Personnel
Documentation
Facilities
Material and
Product
control
Process
assurance
Laboratory
controls
Incident
management

4. 4
10 Commandments of GMP
1. You shall write your procedures
2. You shall follow your procedures
3. You shall document (record) your work
4. You shall design and build proper facilities/ equipment
5. You shall maintain your facilities/equipment
6. You shall validate your work
7. You should be clean
8. You shall be competent ( training & qualification)
9. You shall control for Quality
10. You Should audit for compliance

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GxP
GMP
GDPGLPGDiPGEPGCP
GxP

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Definition
Document:
Any written and approved information or instructions
procedures.
Document Management:
Creation, distribution and deletion of documents

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GDP
Regulatory Expectations
Concise , Legible, Accurate and Traceable Records
Good + Documentation + Practices
 Good : Desired output
 Document : Written evidence
 Practice : A train activity in repeated manner

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Good Document Practices
Concise:
The document must tell the entire story and be understood by
internal /external customers.
Legible:
The document must be readable by internal/external customers.
Accurate:
The document must be error free.
Traceable:
Each aspect of document must be traceable , such as who recorded
it where and why.

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Requirement
 Deals with good and acceptable practices in
document:
 Generation
 Handling
 Distribution
 Archival
 Retiring

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Document Control for…
 Instructions for tasks (procedures)
 Instructions for behaviors (policies)
 Instructions for organization (processes)
 And any associated material related to these
instructions.

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Importance
 Correct and appropriate informations
 Easy to share informations
 Easy to demonstrate
 Easy to collect
 Regulatory appreciates
 Current regulatory requirements
 Harmonised work practices
 Avoid 483’s / Observations
 Expected Practice

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Practices
Documentation
Work Instruction
Procedural Plan
Company Policy
Statutory Requirements
Sequence of
Document

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Document Fundamentals
 Policies
 Procedures
 Records

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Document Fundamentals
Policy:
• High level documents, depicts management
principles, e.g.:
– Quality Policy
– Validation Policy
– Training Policy
• Describes what should be achieved (not necessarily
how)
• Also include the various plans like quality plan,
validation plan, calibration plan etc.

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Document Fundamentals
Procedures:
• The “how” of policies
• Describes what need to be done to achieve the policy
requirements
• Provides details
• Also called SOPs (standard operating procedures), work
instruction etc.
Examples include
Production procedures, testing procedures, maintenance
procedures etc.

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Document Fundamentals
Records:
• Proof of having carried out an activity.
• Proof of having achieved what is required to.
• The final document at the end of a process.
• Tells you how a process was carried out.
• A statutory document.

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Document Fundamentals
 Simple, clear and complete documentation
is at the heart of any Quality Management
System
 Use simple, clear language to ‘state what we
do’ - then only we can ‘do what we state

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Document Fundamentals
 Good documentation is the only proof that
we are (and we were) under control:
 Since your documents may be seen after few
years of generation.
 Since auditors have not witnessed what you
have done.
 Since they depend only on documents.

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Golden rule of documentation
 If it is not documented.
……………It is a rumor !!!!
 If it is documented, but not signed and dated.
…………… It is invalid !!!!
 In God alone we trust…….
…………… All others must provide data !!!!

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Why High standard of documentation
required???
 To ensure that we make safe
and effective medicines.
 To comply with GMP
 To comply with regulatory
requirements.
 Always remember the
innocent unsuspecting
patient far away from you!
He may be
our relative
or we own!!!

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Practices
 Documents remain legible and readily
identifiable.
 Documents of external origin identified and
their distribution controlled
 Prevent unintended use of obsolete
documents, and archiving

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Practices
 Document error correction not signed/dated,
and didn’t include a reason for the correction.
 Write – over's, multiple line-through and use
of "White-out" or other masking device.

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Practices
 Sample sequence table and audit trail not
documented (if its not documented, it didn’t
happen)
 SOP related to production, calibration,
storage and maintenance not authorized by
the QA head.

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Practices
 The delegation for the batch release, in case
of absence of the QA manager, not recorded /
documented.

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Practices
Good PracticeBad Practice

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Practices
 Write the documents in
appropriate manned
 Bind the document
 Review the document
 Approve the document
 Archived the documents

27. 27
General Practices
 Do not over write the entry
 Do not make corrections into the master
documents
 Do not hide if make wrong entry

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How to correct
Sign &
Date
here
Sign &
Date
here

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Good Practices
 Prepare a check list
 Study on subject
 Execute it
 Review it
 Again review it
 Approved it

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Good Practices
 Date writing
12/07/2014 or 12.07.2014
 Document should be written in narrative
form.
 Document should have user friendly
instructions & language

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