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Good Manufacturing Practices

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WHO Technical Report Series, No. 908, 2003, Annex 4. Good Manufacturing ... Effective ventilation. Cross-contamination and contamination. Qualification/validation ... – PowerPoint PPT presentation

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Title: Good Manufacturing Practices


1
Good Manufacturing Practices
Dar Es Salaam, Tanzania August 2006 Dr AJ van Zyl
for Quality Assurance and Safety
Medicines Medicines Policy and Standards Health
Technology and Pharmaceuticals Cluster World
Health Organization
2
Program
  • Good Manufacturing Practices
  • Presentation on GMP (Production focus)
  • Product specific focus
  • Group session
  • Presentation on GMP (QC focus)
  • Product specific focus
  • Group session

3
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. 917, Annex 3. Water WHO Technical
Report Series, No. 937 HVAC and others (2006)
4
Good Manufacturing Practices (GMP)
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
5
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
6
Good Manufacturing Practices (GMP)
10. Training 11. Personal hygiene 12.
Premises General Ancillary areas Storage
areas Weighing areas Production areas Quality
control areas
7
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
8
Good Manufacturing Practices (GMP)
16. Good practices in production General Preve
ntion of cross-contamination and bacterial
contamination during production 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
9
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)

10
Good Manufacturing Practices (GMP)
  • Production
  • Product focus
  • Premises
  • Utilities
  • Equipment
  • Dosage form and data verification (development,
    validation, biobatch, stability, BMR and
    specification)
  • Documentation

11
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

12
Example of Materials and People Flow




Zone Clean

Zone
Packaging

Zone
Controlled
13
Facility layoutFlow of personnel and material,
activities
  • Sampling (starting materials and packaging
    materials)
  • Weighing
  • Mixing
  • Milling
  • Sieving/sifting/screening
  • Granulation
  • Drying
  • Sieving
  • Blending
  • Compression

14
Facility layoutFlow of personnel and material,
activities
  • In process bulk stores
  • Packaging areas (primary and secondary packaging)
  • Finished product

15
Product listType 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

16
Facility layoutFlow 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

17
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
18
Equipment and utilities (2)
  • HVAC air supply and extraction
  • Compressed air machine operation, drying of
    equipment and parts
  • Water washing, rinsing, manufacture
  • Steam cleaning

19
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

20
Utilities
  • HVAC GMP and GEP
  • Effective ventilation
  • Cross-contamination and contamination
  • Qualification/validation
  • Design
  • Installation
  • Operation
  • Performance

21
Air supply and extraction




Red Supply

Green
Exhaust


22
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
    cross-contamination
  • 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

23
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

24
Validation status
  • Validation Master Plan
  • Manufacturing areas
  • Utilities
  • Equipment
  • Manufacturing process
  • Cleaning validation
  • Computer systems
  • Others

25
On site verification
  • From receiving to stores
  • Sampling and weighing
  • Manufacturing areas
  • Utilities
  • Documentation review

26
Sampling and weighing
27
Examples of control measures
Temperature Cooling coil
Relative humidity Dehumidifier
Particulate matter Filters
Air movement and pressure differentials Fan
28
Re-circulation Air System
HEPA filters installed?
ISPE Baseline Vol. 2 6.3.3 (d) WHO HVAC Guideline
29
(No Transcript)
30
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

31
Documentation review
  • Equipment and utilities
  • SOPs (operation, cleaning, calibration)
  • Records and use logs
  • Calibration records/certificates
  • Preventative maintenance and maintenance
  • Qualification

32
Documentation review
  • Product related
  • Batch Manufacturing document as per product
    dossier
  • Process Validation protocol and report
  • Bio-batch records
  • Stability batches
  • Batch records

33
Documentation review
  • Other documents
  • SOPs including
  • Cleaning
  • Complaints
  • Recalls
  • Validation protocols and reports including
  • Cleaning validation
  • Computer validation

34
Documentation review
  • Inspection of the quality control laboratory

35
Group session
  • Group 1
  • Group 2
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