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GMP Production

The document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses GMP guidelines and references, introduces GMP concepts and considerations, and outlines specific aspects of GMP including production, quality control, facilities, equipment, materials, documentation, and more.

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Ardy Novrianugrah
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189 views

GMP Production

The document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses GMP guidelines and references, introduces GMP concepts and considerations, and outlines specific aspects of GMP including production, quality control, facilities, equipment, materials, documentation, and more.

Uploaded by

Ardy Novrianugrah
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Good Manufacturing

Practices

Guilin, PRC

Dr AJ van Zyl
for
Quality Assurance and Safety: Medicines
Medicines Policy and Standards
Health Technology and Pharmaceuticals Cluster
World Health Organization

Program
Good Manufacturing Practices
Presentation on GMP (Production focus)
Product specific focus
Group session
Presentation on GMP (QC focus)
Product specific focus
Group session

Guidelines and references


GMP: World Health Organization
WHO Technical Report Series, No. 908,
2003, Annex 4. Good Manufacturing
Practices for pharmaceutical products:
main principles
WHO Technical Report Series, No. Annex
3. Water
WHO Technical Report Series, No. Annex
3. HVAC

Good Manufacturing
Practices (GMP)
Introduction
General considerations
Glossary
Quality management in the drug industry: philosophy and
essential
elements
1. Quality assurance
2. Good manufacturing practices for pharmaceutical products
(GMP)
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
General
The contract giver
The contract accepter
The contract

Good Manufacturing
Practices (GMP)
8. Self-inspection and quality audits
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Follow-up action
Quality audit
Suppliers audits and approval
9. Personnel
General
Key personnel
10. Training
11. Personal hygiene
12. Premises
General
Ancillary areas
Storage areas
Weighing areas
Production areas
Quality control areas

Good Manufacturing
Practices (GMP)
13. Equipment
14. Materials
General
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected, recovered, reprocessed and reworked
materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous
15. Documentation
General
Documents required

Good Manufacturing
Practices (GMP)

16. Good practices in production


General
Prevention of cross-contamination and
bacterial contamination duringproduction
Processing operations
Packaging operations
17. Good practices in quality control
Control of starting materials and intermediate,
bulk and finished products
Test requirements
Batch record review
Stability studies

Good Manufacturing
Practices (GMP)
Production
Utilities
Equipment
Dosage form and data
verification (development,
validation, biobatch, stability,
BMR and specification)
Quality control
API, excipients
Packaging material
Data verification (e.g. stability)

Good Manufacturing
Practices (GMP)
Production
Product focus
Premises
Utilities
Equipment
Dosage form and data
verification (development,
validation, biobatch, stability,
BMR and specification)
Documentation

Good Manufacturing
Practices (GMP)
Where to start the inspection?
Facility layout
Flow of personnel and
material, activities
Product list
Type of products, dosage
forms, activities
Utilities (HVAC, water, etc)
Validation status

Example of Materials and People Flow

QC

Offices

Canteen
Gowning

Incoming
goods

Corridor

Shipping

Corridor
Corridor
Raw
Materials
&
Packaging Weighing
Storage

Zone: Clean

Processing

Washing

Filling

Packaging Finished
Products
Storage

Machine
Shop

Utilities and Services

Packaging
Controlled

Corridor
Waste Treatment

Facility layout
Flow of personnel and material,
activities

Sampling (starting materials and


packaging materials)
Weighing
Mixing
Milling
Sieving/sifting/screening
Granulation
Drying
Sieving
Blending
Compression

Facility layout
Flow of personnel and material,
activities

In process bulk stores


Packaging areas (primary and
secondary packaging)
Finished product

Product list
Type of products, dosage forms,
activities

Multi-product
Various tablets
Uncoated artesunate
Risk of cross-contamination and
contamination
Non dedicated areas and
equipment
Batch to batch consistency

Facility layout
Flow of personnel and material,
activities

Batch Manufacturing Document


Formula and manufacturing steps
API and excipients
Properties and requirements for
temperature or RH control
Material quantities, batch size
Sub lots
Equipment and utilities
Production areas

Equipment and utilities (1)


Sieving/sifting sifter (e.g. vibrosifter)
Mixing mixer
Granulation - granulator
Drying fluid bed drier
Blending octagonal blender
Compression compression machine
Packaging - blister machine
Others include Metal detector, sieves,
punches and dies
In process quality control instruments and
equipment may include hardness tester,
disintegration tester, balance, caliper

Equipment and utilities (2)

HVAC air supply and extraction


Compressed air machine
operation, drying of equipment and
parts
Water washing, rinsing,
manufacture
Steam cleaning

Utilities
The environment may be influenced by:

Light
Temperature
Humidity
Air movement
Microbial contamination
Particulate contamination

Uncontrolled environments can lead to:


Product degradation
Product contamination
Loss of Product & Profit

Utilities
HVAC: GMP and GEP
Effective ventilation
Cross-contamination and
contamination
Qualification/validation
Design
Installation
Operation
Performance

Air supply and extraction

QC

Offices

Canteen
Gowning

Incoming
goods

Corridor

Shipping

Corridor
Corridor
Raw
Materials
&
Packaging Weighing
Storage

Red: Supply

Processing

Washing

Filling

Packaging Finished
Products
Storage

Machine
Shop

Utilities and Services

Corridor
Waste Treatment

Green: Exhaust

Problems with components

Filters

Fan

Flow rate controller

Control damper

Humidifier

Cooling coil

Ducts

Incorrect retention rate/leaking/badly


installed
Low air flow loss of pressure cascade
Blocked poor pressure cascade crosscontamination
Poorly adjusted, bad pressure differential
system
Bad water/steam quality/poor drainage/
No elimination of condensed water/poor
drainage/stagnating water
Inappropriate material/internal insulation
Leaking ducts

Utilities: Water systems


Type of water
Intended use
Quality (specification)
Design of the system
Qualification and validation
Ongoing monitoring and quality
control
Sampling, testing, trends

Validation status
Validation Master Plan
Manufacturing areas
Utilities
Equipment
Manufacturing process
Cleaning validation
Computer systems
Others

On site verification

From receiving to stores


Sampling and weighing
Manufacturing areas
Utilities
Documentation review

Sampling and weighing

P o w d e r
C o n t a in e r

F lo o r S c a le

Weighing

Granulation

Blending

Blister line

AHU

Examples of control measures:


Temperature

Cooling coil

Relative humidity

Dehumidifier

Particulate matter

Filters

Air movement and


pressure
differentials

Fan

Re-circulation Air System


H E P A
F IL T E R

S E C O N D A R Y
F IL T E R

S U P P LY
A IR F A N

C O O L IN G C O IL

P R IM A R Y
F IL T E R

A IR H A N D LIN G U N IT

HEPA filters
installed?
P r o d u c tio n
R oom

ISPE Baseline Vol. 2 #6.3.3 (d)


WHO HVAC Guideline

Typical de-ionizer schematic


from water softener

Water
must be
UV light
kept
circulatin
g

HCl

NaOH

5
4
3
2
1

5
4
3
2
1

Cationic column

Anionic column

Cartridge
filter 5 m

Eluates to
neutralization
plant

Cartridge
filter 1 m
Ozone generator

Hygienic pump
Return to de-ioniser
Outlets or storage.
Drain line
Air break to sewer

Documentation review
HVAC
DQ, IQ, OQ, PQ
Important aspects including air
flow direction, filtration, air
changes, pressure differentials
Water
DQ, IQ, OQ, PQ
Sampling and testing

Documentation review
Equipment and utilities
SOPs (operation, cleaning,
calibration)
Records and use logs
Calibration records/certificates
Preventative maintenance and
maintenance
Qualification

Documentation review
Product related
Batch Manufacturing document as
per product dossier
Process Validation protocol and
report
Bio-batch records
Stability batches
Batch records

Documentation review
Other documents
SOPs including:
Cleaning
Complaints
Recalls
Validation protocols and reports
including:
Cleaning validation
Computer validation

Documentation review
Inspection of the quality control
laboratory

Group session
Group 1

Group 2

Documentation review
Q

Documentation review
Q

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