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Good documentation constitutes an essential part of the quality assurance system
and is key to operating
in compliance with GMP requirements. The various types of documents
and media used should be
fully defined in the manufacturers Quality Management
System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media.
The main objective of the system of documentation utilised must be to establish
, control, monitor and record all activities which directly or indirectly impact on
all aspects of the quality of medicinal products . The Quality Management System
should include sufficient instructional detail to facilitate a common understanding of the requirements, in addition to providing for sufficient recording of the various processes and
evaluation of any observations, so that ongoing application of the requirements may be demonstrated.There are two primary types of documentation used to manage and record
GMP compliance: instructions directions, requirements and recordsreports
. Appropriate good documentation practice should be applied with respect to the type of
document.Suitable controls should be implemented to ensure the accuracy, integrity,
availability and legibility of documents . Instruction documents should be free from errors
and available in writing. The term ‘written’ means recorded, or documented on media from which data may be rendered in a human readable form.
.
3. Chapter 4: Documentation
PRINCIPLE
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3. Chapter 4: Documentation
Documentation is the material
that provides official information or evidence or that serves as a record.
Documentation is the process
of classifying and annotating texts, photographs, etc.
What is documentation?
Mate ial
P o ess
Do u e tatio
Offi ial i fo atio
• App o ed dated • Regula l e ie ed
• Re isio o t ol
E ide e • A ou ta ilit
• T a ea ilit
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3. Chapter 4: Documentation
Unlike other industrial products, you cannot test each finished drug on your production line end.
All concepts of GMP, SOP and Validation have been introduced to address the issues on drug manufacturing.
Notably, all these concepts are based on documentation and by documentation.
Why documentation is essential?
GMP
≠
Get More Paper
But, pape eall does atte
The truth about GMP
e, of ou se,
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3. Chapter 4: Documentation
For example: FDA Inspection Observation Summaries by frequency
Cited ef. Sho t des iptio
Lo g des iptio FY
FY FY
CFR . d P o edu es ot i
iti g, full follo ed The espo si ilities a d p o edu es appli a le to
the ualit o t ol u it a e ot [i iti g] [full follo ed]. Spe ifi all ,
CFR .
I estigatio s of dis epa ies, failu es
The e is a failu e to tho oughl e ie [a u e plai ed dis epa
] [the failu e of a at h o a of its o po e ts to eet a of its
spe ifi atio s] hethe o ot the at h has ee al ead dist i uted. Spe ifi all ,
CFR .
a A se e of W itte
P o edu es The e a e o itte p o edu es fo p odu tio
a d p o ess o t ols desig ed to assu e that the d ug p odu ts ha e the ide tit , st e gth, ualit ,
a d pu it the pu po t o a e ep ese ted to possess. Spe ifi all ,
CFR .
S ie tifi all sou d la o ato o t ols
La o ato o t ols do ot i lude the esta lish e t of s ie tifi all sou d a d
app op iate [spe ifi atio s] [sta da ds] [sa pli g pla s] [test p o edu es] desig ed to assu e that
[ o po e ts] [d ug p odu t o tai e s] [ losu es] [i ‐p o ess ate ials] [la eli g] [d ug p odu ts]
o fo to app op iate sta da ds of ide tit , st e gth, ualit a d pu it . Spe ifi all ,
Procedures not in writing, fully followed that has ranked the top for three consecutive years
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3. Chapter 4: Documentation
