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PICS GMP GUIDE PART I:
BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS
Chapters
Part I
Chapte Chapte Chapte Chapte Chapte Chapte Chapte Chapte Chapte
1.QMS 2. Personnel
3. Premisesequipment 4. Documentation
5. Production 6. QC
7. CMO 8. Complaintsrecall
9. Self inspection
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Regulatory Compliance
T a a
a a a y a
a , a
a a
a .
PICS GMP has been becoming a global standard
The ultimate spirit of GMP:
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Quality Management System QMS
= Quality System = Quality Assurance
Recap of Chapter 1: Quality Management
QMS
Continuous improvement throughout the life cycle
GMP
Quality assurance in day-to-day production activities
Quality
QC
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GMP
QC PQR
Ma k Pete
Tho as Bill
Mi hael Ri ha d
QRM
PQR
To ensure that the medicinal products produced are;
fit for their intended use, comply with the requirements
of the market authorization, do not place patients at risk
due to inadequate safety
, quality
or efficacy
.
Principle of Quality Management
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Method
Machine
Man= Personnel
Material Personnel
Training Key
personnel Personnel
hygiene
Recap of Chapter 2: Personnel
a ade uate u e
of pe so el e essa ualifi atio s
p a ti al e pe ie e itte jo des iptio s
Ma k Pete
Tho as Bill
Mi hael Ri ha d
o ga isatio ha t
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QA relies upon correct manufacture 4Ms, which rely upon people
.
Principle
Pe so el
P o ess
Validatio
Sa pli g
Re o d Release
Fo ula
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1. A Quick Recap of Our Previous Session
