Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 1 |
Good Practices in Production and Quality Control Related Guidelines
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.
Good Practices in Production and Quality Control.
Related Guidelines
John Startup
Good Practices in Production and Quality Control.
Related Guidelines
John Startup
JOHN STARTUP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 2 |
Good Practices in Production and Quality
Control.
Related Guidelines
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 3 |
The Ten Commandments of GMP
Basic Principles of GMP
Section 16 and 17
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 4 |
The Ten Commandments of
GMP1 Build Adequate Premises
2 Equip Your Premises with plant and services fit for purpose.
3 Maintain your premises and equipment
4 Write procedures
5 Validate your work/procedures
Basic Principles of GMP
Section 16 and 17
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 5 |
The Ten Commandments of GMP
6 Train your workforce
7 Record your work
8 Be clean in all things
9 Test for Quality
10 Audit for compliance.
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 6 |
The WHO Guidelines
EEC Guidelines(ORANGE GUIDE
Eudralex Guidelines
FDA Guidelines(CFR)
MHRA Specific Topics
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 7 |
Well documented and respected guidelines.
Most available on the internet (OG is the exception)
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 8 |
Do not forget EP, BP,USP
Setting standards as opposed to
guidelines
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 9 |
PREMISESEEC 1.3
Specifically Annexe 1 Sterile Manufacture
WHO Chapter 1 .12
HVAC
Chapter 3 Sterile Manufacture.
Eudralex Monograph
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 10 |
EQUIPMENTEEC 3 and 5 (production)
Specifically Annexe 1 Sterile Manufacture
WHO Chapter 1 (includes HVAC) Chapter 3 Sterile
Manufacture.
Eudralex Guideline. Also Sterile Manufacture.
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 11 |
CARE and MAINTENANCEEEC 3.34 to 3.44 Cleaning and maintenance.
WHO 1.13
Company SOP for service schedule and pre programmed
Maintenance (PPM)
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 12 |
WRITE PROCEDURESAddressed in the Documentation
chapters of the guidelinesEEC 4.19 to 4.29
Include but not limited to
• Inventory control
• Sampling
• Testing and status control
• Manufacture and packaging
• Hygiene /environmental monitoring & control
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 13 |
WRITE PROCEDURESAddressed in the Documentation
chapters of the guidelines
WHO 1.15
Eudralex
PIC Annexe 13
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 14 |
VALIDATIONValidation protocols usually have a
generic format #
See WHO 1 appendix 6
Validation Master Plan
PIC guideline 10063
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 15 |
VALIDATION“A recorded protocol which demonstrates with a high degree of probability that any activity will repeatedly produce a result within a pre determined specification/requirement. ”
All aspects of pharmaceutical manufacture require validation.
Sufficiently important to be referred to throughout the guidelines. eg. WHO 1 appendix 6
Normally states the requirement (not negotiable) but rarely “how to”
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 16 |
TRAININGWHO 1.10 and EEC 2.8 to 2.12
Detail training requirements
• General company culture
• On the job
• Outside courses
• Tests for proficiency
• Authorisation
• Training records
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 17 |
RECORDSFound in the documentation chapters of
the guidelines.
Examples
• Analytical test records
• Batch manufacturing documents (BMR)
• Cleaning records
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 18 |
CLEANLINESS AND HYGIENE
Fleeting reference in EEC and WHO
Guidelines
PIC gives better information #
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 19 |
QUALITYQuality Assurance
Both OG and WHO describe in detail the
elements of a robust quality system.
Emphasises its all embracing function
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 20 |
QUALITYQuality Control
Quality control of raw materials
Components
Intermediates and finished products.
Microbiology
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 21 |
QUALITYQuality Control
WHO 1.17 EEC 12.6
Quality control of raw materials
Components
Intermediates and finished products.
Microbiology
$ #
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 22 |
AUDITING FOR COMPLIANCE
WHO 1.8
EEC2.9
Describes the procedures
Aspects of pharmaceutical production to be
assessed.
Includes audits of suppliers.
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 23 |
Basic Principles of GMPBasic Principles of GMP
So what else is there?
ISO9000GAMP
??????
HTM 2010 Validation
of Autoclaves
BS 6001
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 24 |
OTHERS
ISPE Publications on good
Pharma Practice
HTM 2010 Validation of
Autoclaves
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 25 |
WHAT ELSE IS THERE Contract manufacture.
Technical agreements.
WHO 1.7
EEC 2.7
Both define contract giver and acceptor
And their individual and shared
responsibilities
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 26 |
WHAT ELSE IS THERE Complaints
Recalls
Returns
Stability programmes.
Basic Principles of GMP
Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 27 |
All the guidelines presented are objectives which
are not negotiable
Nowhere does it say if it costs too much one can
ignore the guideline
Nowhere does it say if the resources are
unavailable the guideline can be ignored.
Whist not negotiable, the means /ways of
achieving the objectives are a matter of company
style” one man’s solution is another man’s
disaster.
Basic Principles of GMP