2. 2
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
6. 6
Definition
Document:
Any written and approved information or instructions
procedures.
Document Management:
Creation, distribution and deletion of documents
7. 7
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
8. 8
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.
9. 9
Requirement
Deals with good and acceptable practices in
document:
Generation
Handling
Distribution
Archival
Retiring
10. 10
Document Control for…
Instructions for tasks (procedures)
Instructions for behaviors (policies)
Instructions for organization (processes)
And any associated material related to these
instructions.
11. 11
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
14. 14
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.
15. 15
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.
16. 16
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.
17. 17
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
18. 18
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.
19. 19
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 !!!!
20. 20
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!!!
21. 21
Practices
Documents remain legible and readily
identifiable.
Documents of external origin identified and
their distribution controlled
Prevent unintended use of obsolete
documents, and archiving
22. 22
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.
23. 23
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.
24. 24
Practices
The delegation for the batch release, in case
of absence of the QA manager, not recorded /
documented.
29. 29
Good Practices
Prepare a check list
Study on subject
Execute it
Review it
Again review it
Approved it
30. 30
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
