Documentaion in GMP

1. Presented by:
Vinitha Nair
M.Sc Bio-analytical Sciences
Part 2

2. Contents

3. Why Documentation is necessary?
Documentation
is a key area for
companies in
the
pharmaceutical
industry.
This practice is
to ensure safe
and effective
pharmaceutical
products.

4. Why is it done?
To ensure that the personnel authorized to release a batch
for sale or reject it, have all the information that is
necessary to take decision.
To ensure that all personnel
connected with manufacturer and
control know what to do and when to
do.
To define the
specification for all
materials, methods
of manufacture and
control.
To provide
information during
investigation, if a
batch is suspected to
have defect(s).
To make
available data
needed for
validation
, review and
statistical
analysis.

5. Points To Be Noted!!!
1
• Documents should specify the title, nature
and purpose.
2
• They should be laid out in an orderly fashion
and should be easy to check.
3
• Reproduced documents should be clear and
legible.
4
• Documents should be regularly reviewed and
kept up to date.
5
• Any alteration made in the entry of a
document should be signed and dated.

6. Important documents as per GMP
Policies
SOP
Specifications
MFR
BMR
Manuals
Master plans/ files
Validation protocols
Labels
Records

7. Important Documents
 Standard Operating Procedure (SOP): A
document that describes a routine procedure
of general use which is not specific to one
product.
 Master Production and Control Record
(MPCR): A document that describes the
procedure for the preparation of a specific
product.
 Batch Production and Control Record (BPCR):
An exact copy of the approved MPCR issued
for each production batch to record the data
for that particular batch.

8. Attributes of a good document
Accurate
Clear
Complete
Consistent
IndelibleLegible
Timely
Direct
Authentic
Authorized

9. Certifying agencies
ICH
• www.ich.
org
WHO
• www.who.i
nt
US FDA
• www.fda.g
ov
EU/EMEA
• www.eme
a.europa.e
u

10. Bottom Line
“If it is not documented . . .it
did not happen!”
or, it’s a rumor!”
In FDA-speak

11. References
• www.ncbi.nlm.nih.gov
• www.slideshare.net
• www.smccd.net
• ec.europa.eu
• www.gmp-compliance.org
• onlinelibrary.wiley.com
• www.hc-sc.gc.ca › ... › Guidance Documents