Welcome [40rik02ft2xye26xv2i0y0yc-wpengine.netdna-ssl.com] · 2019-12-19 · Qualification (DQ)...
Transcript of Welcome [40rik02ft2xye26xv2i0y0yc-wpengine.netdna-ssl.com] · 2019-12-19 · Qualification (DQ)...
Slide 1 © PharmOut 2018
2019 Medicinal Cannabis Expo Johannesburg
Welcome
Esthi Bosch –Manufacturing PharmacistNovember 2019
Slide 2 © PharmOut 2018
About PharmOut
PharmOut is a leading international consultancy offering architectural, engineering, compliance, validation, regulatory, consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, and more recently medicinal cannabis (3 years).
PharmOut holds ISO 9001:2015 certification from LRQA. Our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.
SA Company and Local OfficesSince April 2019
Slide 3 © PharmOut 2018
Our Cannabis Specific Services
• Licensing, any country
• EU-PIC/S Compliance
• Regulatory submissions
• Quality Management Systems
• Cultivation Consulting
• GACP/GMP Cultivation Training
• Master & Strategic planning
• Architecture and design
• Engineering
• Equipment selection
• Qualification and Validation
• Temp., Light & RH Mapping
Slide 4 © PharmOut 2018
Two Pillars of ALL Pharmaceutical Products beforeyou can sell product
Marketing Authorisation
• Double blind ClinicalEvidence that it prevents, cures or alleviates symptoms.
Good Manufacturing Practice (GMP)
• Evidence of systems to ensure safe and reproducibleproduction
Product Registration and Manufacturing License
Slide 5 © PharmOut 2018
Medicinal Cannabis
Software – Paperwork
Validation Lifecycle
- 3 stages of validation
Control Strategy
- Drives the “Design”
Pharmaceutical Quality System
- 200 documents
Hardware - Facility
Facility
- fabric, logical layout, mix up
Services
- power, water, laboratories
Equipment
- non reactive, cleanable
Slide 6 © PharmOut 2018
United Nations Single Drug Convention 1964
• Most countries are signatories to this convention
• Countries have since 1964 enacted laws to control drugs (beneficial and harmful drugs)
• Cannabis remains a banned substance, but it is changing
• Poisons scheduling
• Cannabis for non medicines are schedule 9 drugs, no useful medical use, but CBD and THC have clinical evidence
• USA THC from a botanical source is banned (USP).
Slide 7 © PharmOut 2018
PIC/S Guide to GMP
Currently 54 authorities have adopted (28 from Europe)
•GMP Guidance’s used as regulatory requirements by EU and Asia-Pacific countries, including South Africa
•Is an informal “Cooperative Arrangement” between GMP regulatory authorities; i.e. it’s not a legal treaty.
PIC/S – Pharmaceutical Inspection Co-op Scheme
No obligation for member authorities to accept inspection reports of other members.
Slide 8 © PharmOut 2018
Introduction to PIC/S GMP Guidelines
PIC/S PE 009 Guide to Good Manufacturing Practices is in 3 parts:
Guide to Good Manufacturing Practice for Medicinal Products Part I
Guide to Good Manufacturing Practice for Medicinal Products Part II (API manufacturing)
Guide to Good Manufacturing Practice for Medicinal Products Annexes
Slide 9 © PharmOut 2018
54 PIC/S member authorities (1 January 2019)
4 Partners
EDQMEMA
UNICEFWHO
New Zealand
Iceland
Canada
USA
Argentina
South Africa
Australia
Malaysia
Taiwan
Switzerland
Norway
Indonesia
Ukraine
Singapore
Israel
Liechtenstein
EUROPEAN UNION Member States Agencies (29)
Japan
South Korea
Hong Kong
Thailand
Mexico
Iran
Turkey
Newest members 1 Jan 2018
Slide 10 © PharmOut 2018
Pharmacopeia – 20
1. Pharmacopoea Slovaca
2. Indonesian Pharmacopoeia
3. Brazilian Pharmacopoeia
4. British Pharmacopoeia (BP)
5. British Pharmaceutical Codex
6. Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia)
7. Czechoslovak Pharmacopoeia
8. German Pharmacopoeia (GP)
9. Pharmacopoeia of the United Mexican States (Mexican Pharmacopoeia)
10.Portuguese Pharmacopoeia
11.Indian Pharmacopoeia
12.Japanese Pharmacopoeia (JP)
13.Minimum Requirements for Antibiotic Products of Japan
14.Czech Pharmacopoeia
15.European Pharmacopoeia (EP)
16.French Pharmacopoeia
17.Swiss Pharmacopoeia
18.Hungarian Pharmacopoeia
19.International Pharmacopoeia
20.Royal Spanish Pharmacopoeia
21.United States Pharmacopeia (USP)
22.State Pharmacopoeia of the Union of Soviet Socialist Republics (Soviet Pharmacopoeia)
23.Yugoslav Pharmacopoeia
Slide 11 © PharmOut 2018
Six (EU – PIC/S) GMP requirements
Front End
Engineering
Study
(FEED)
Functional
and
Detailed
Design
Facility User
Requirement
Specification
(URS)
Tender Construction Installation CommisioningFacility
Handover
Validation
Master
Plan
(VMP)
Factory
Acceptance
Testing
(FAT)
Design
Qualification
(DQ)
Qualification
Protocol
Development
Pre-delivery
Inspection
(PDI)
Execute Installation
Qualification (IQ)
and Operational
Qualification (OQ)
Execute
Performance
Qualification
(PQ)
Facility/
Equipment
approved for
Manufacture
Supplier
Assessment
Process
Validation
Summary
Report
GMP /
Quality Risk
Assessment
Project
plannning/
scoping (includes org
structure)
System
Implem-
entation
Project Plan
and Schedule
Monitor
system for
effectiveness
System
development
and approval
Training and
assessment
Quality
Manual /
Policies
User
Requirement
Specification
Functional
Specification
(FS)
GMP Risk
Assessment
Design
Qualification
(DQ)
Factory
Acceptance
Testing (FAT)
Operational
Qualification
(OQ)
Performance
Qualification
(PQ)
Quality and
Project Plan
(QPP)
Pre-delivery
Inspection
(PDI)
Design
Specification
(DS)
Installation
Qualification
(IQ)
Qualification
Protocol
Development
Validation
Summary
Report (VSR)
ConstructionSupplier
Assessment
Site
Master
File
Rectify any
identified
deficiencies
GMP
license
application
Pre-GMP
licensing
audit
Lodge
application
with TGA
Requirement 1
GMP Facility Design, Construction and Validation
Obtain GMP
license
Requirement 3
GMP Quality System Development and Implementation
Requirement 2
Equipment / Lab Method / IT Validation
Requirement 5
TGA Good Manufacturing Practice (GMP) License
Requirement 6
Regulatory Product Registration
Common
Technical
Document
Product
Registration
TGA GMP Requirements for Pharmaceutical Drugs
Commercial
Manufacturing
Raw Material
Specifications
In-process
Specifications
Finished
Product
Specification
Requirement 4
Product Characterisation/Specification
Purchase
Purchase
Validation
Master
Plan
(VMP)
Most requirements are concurrent
Quality System Elements- Product Realisation + Raw Material procurement & assurance
+ Manufacture
+Testing
+ Batch Release
+Storage & Distribution
Supporting sub-systems- Document Control
- Vendor Assurance
- Training
- Validation
- Calibration
- Preventative Maintenance
- Deviation Management (CAPA)
- Change Control
- Self Inspection
A typical GMP compliant quality
system would include SOPs and
sub-systems as defined above.
Slide 12 © PharmOut 2018
SAHPRA licensing process
• Need a solid business plan
• What is the pharmaceutical product you want to manufacture?
• The Facility must be built (similar to Greece)
• Security must be in place (expect to spend more than a R1m)
• Complete forms and submit
• Inspection
• Issue permit
• Reinspect
Slide 13 © PharmOut 2018
Thank you
Esthi Bosch
[email protected] www.pharmout.net www.pharmout.co.za
I’m very happy to share my presentation.