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Overview
1
What is GMP?
2
Regulations, Codes and Guides
Differences between:
4
GMP Compliance Focus
GMP
Purity Identity
MHRA EU
KFDA
HPB
PMDA
FDA
TGA
PIC/S WHO
Major International Codes of GMP
7
Regulatory Agency and Industry Web Sites
• TGA - http://www.tga.gov.au/
• PIC/s www.picscheme.org
• FDA - www.fda.gov/
• EU Code of GMP - www. pharmacos.eudra.org/
• European Medicines Agency www.emea.eu.int/
• HPB Canada - www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate
• International Conference for Harmonisation (ICH) -
www.ich.org
• Medicines & Healthcare products Regulatory Agency -
www.mhra.gov.uk/
8
Key GMP Requirements
9
Quality Assurance/Quality Control
10
Relationship Between QA, GMP and QC
11
Premises
Principle
• Premises must be located, designed, constructed, adapted and
maintained for the operations:
– Minimize risks of errors and cross-contamination
– Permit effective cleaning
– Permit effective maintenance
– Minimize build-up of dirt and dust
– Eliminate any adverse effects on quality
• Premises must be located to minimize risks of cross-
contamination; e.g. not located next to a malting factory with
high airborne levels
12
Premises
Location
• Geography, climate, noise and economic factors
• Neighbours
– What do they do?
– What impact can they have on the business?
• Pollution/effluent control
13
Premises
14
Premises
15
Premises
16
Premises - Containment
17
Containment as part of Facility Design
18
Premises
Washing Machine
Shop
Corridor
Utilities and Services Waste Treatment
19
Equipment
Principle
• Equipment must be
– located
– designed
– Constructed
– Installed
– Validated
– maintained
to suit their intended use
20
Equipment
Principle
• Equipment layout and design must aim:
– to minimize risks of error
– to permit effective cleaning
– to permit effective maintenance
• And to avoid:
– cross-contamination
– dust and dirt build-up
– any adverse effect on the quality of products
• Equipment must be installed to:
– minimize risks of error
– minimize risks of contamination
21
Equipment
23
Documentation & Records
What is
being made?
Most of us when
attempting a task
need some sort of
documentation
24
Documentation & Records
25
Documentation & Records
27
Types of GMP Documents/ Records
29
Validation
30
… there are real benefits from
Validating:
• Regulatory compliance
• Minimise corporate product liability risk
• Maximise yields
• Maximise capacity
• Minimise rejects
• Minimise rework
• Minimise complaints
• Reduce unit cost
• Reduce testing requirements
• Reduce new facility/process start-up time
31
Key Validation Terms Defined
32
Sequence of Validation
Production
Periodic
Registration
Product
Start-up
Design Process
Facility/Equipment Product Scale Reviews
Phase Qualification Phase up & Transfer
Time
33
“V Model” for Validation - Relationship
(Specifications and Protocols)
User Is based on
PQ
Design Qualification
Specification
Functional Is based on
OQ
Specification
Is based on
Design
IQ
Specification
Commissioning
Implementation
34
Validation & Project Life Cycle
Enhanced Design
Commissioning Process
Review DQ PQ Validation
IQ & OQ
35