regulatory considerations for herbal products sg.pptx...
TRANSCRIPT
Regulatory Considerations for Regulatory Considerations for Herbal Products
Sultan GhaniSultan GhaniFormer Director Health CanadaDirector, Drug Information Association, IndiaDirector, Drug Information Association, India
Focus of PresentationFocus of Presentation
Brief Overview of GMPs
Product License SystemProduct License System
Quality Management SystemQuality Management System
ConclusionConclusion
Brief Overview of GMPsBrief Overview of GMPsGood Practices in Productions: Good Practices in Productions:
Starting from Communicating in manufacturing ProcessHerbal ExtractionHerbal ExtractionAll production following primary cutting & comminutingcomminutingFermentation Process
Brief Overview of GMPsBrief Overview of GMPsGood Practices in Quality ControlGood Practices in Quality Control
Personal must have necessary expertise of herbal medicine
With respect to identification
Recognition of adulterationRecognition of adulteration
Quality control of herbal material herbal
preparation and finished herbal product.preparation and finished herbal product.
Brief Overview of GMPsBrief Overview of GMPsGood Practices in Quality ControlGood Practices in Quality Control
Quality control testing : Qualitative and Quantitative
Reference samples if availableReference samples if available
Specification and test methods
Validation of analytical procedure
Stability testing to support expiry dateStability testing to support expiry date
Brief Overview of GMPsBrief Overview of GMPsOther GMP Consideration:Other GMP Consideration:
Premises- Design, Location
Storage- Contamination, Cleanliness
Production Area- Dedicated premises
Brief Overview of GMPs
Sanitation & Hygiene: Microbiological Contamination
Brief Overview of GMPs
Sanitation & Hygiene: Microbiological Contamination
Qualification and validation
Self Inspection- Routine validation studies
Personnel: Training, Knowledge& expertisePersonnel: Training, Knowledge& expertise
Training : Pharmaceutical Technology, Taxonomic,
Phytochemistry, Pharmacology
Brief Overview of GMPs
Equipments: Effective Cleaning
Brief Overview of GMPs
Equipments: Effective Cleaning
Materials: Non Wooden Reference sample & standardMaterials: Non Wooden Reference sample & standard
Documentation: Control, SOPs etc.
Packaging Material & Labeling
Product License System (CANADA)
Product License is needed in many regulated countries
Product License System (CANADA)
Product License is needed in many regulated countries
Product License ApplicationProduct License Application
Product License Amendment
Product License Notification
Product License SystemProduct License System
Application ContentApplication Content
Site InformationSite Information
Product Information
Medicinal IngredientsNon Medicinal ingredients
Attestation
Qual ity Management SystemsQual ity Management Systems
Quality Assurance:
Improving and stabilizing production, processes to Improving and stabilizing production, processes to avoid defects
Quality Control: Testing and releasing the productTesting and releasing the product
Qual ity Management SystemsQual ity Management Systems
Key Elements:
Personal Training
Controlling Product Design
Controlling DocumentationControlling Documentation
Controlling Purchasing
Product Identification &and traceability at all stages
Qual ity Management Systems
Controlling & defining production & process
Qual ity Management Systems
Controlling & defining production & process
Controlling non-conformance
Correcting and Prevention Action (CAPA) when error
occurs
Labeling & packaging control
Storage and distributionStorage and distribution
Records
Qual ity Management Systems
Recent Guidelines
Qual ity Management Systems
Recent Guidelines
ICH Q9: Present systematic methodology on statistical ICH Q9: Present systematic methodology on statistical tools for assessment control, communication and review of risk to the quality of drug product across the product life cyclelife cycle
ICH Q10: Provide a harmonized model for a ICH Q10: Provide a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product
Conclusions
Application of GMPs in the manufacture of herbal medicine
is an essential tool to assure their quantity
Quantity Management System is an important component Quantity Management System is an important component
of not only producing high quality product but also achieve
sustained profitability. The attainment of the system is sustained profitability. The attainment of the system is
responsibility of senior management
Many regulatory agencies have developed comprehensive Many regulatory agencies have developed comprehensive
regulations of herbal/ Natural health product
Quality is a state of mind.
