1. Good Practices in Production and Quality Control Related Guidelines
Good Practices in Production and Quality Control. Related Guidelines John Startup
Good Practices in Production and Quality Control Related Guidelines
JOHN STARTUP
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.

2. World Health Organization
24 April, 2017
Basic Principles of GMP
Good Practices in Production and Quality Control.
Related Guidelines
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

3. World Health Organization
24 April, 2017
Basic Principles of GMP
The Ten Commandments of GMP
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)
Section 16 and 17

4. World Health Organization
24 April, 2017
Basic Principles of GMP
The Ten Commandments of GMP
1 Build Adequate Premises
Equip Your Premises with plant and services fit for purpose.
Maintain your premises and equipment
Write procedures
Validate your work/procedures
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)
Section 16 and 17

5. World Health Organization
24 April, 2017
Basic Principles of GMP
The Ten Commandments of GMP
Train your workforce
Record your work
8 Be clean in all things
9 Test for Quality
10 Audit for compliance.
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

6. World Health Organization
24 April, 2017
Basic Principles of GMP
The WHO Guidelines
EEC Guidelines(ORANGE GUIDE
Eudralex Guidelines
FDA Guidelines(CFR)
MHRA Specific Topics
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

7. World Health Organization
24 April, 2017
Basic Principles of GMP
Well documented and respected guidelines.
Most available on the internet (OG is the exception)
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

8. World Health Organization
24 April, 2017
Basic Principles of GMP
Do not forget EP, BP,USP
Setting standards as opposed to
guidelines
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

9. World Health Organization
24 April, 2017
Basic Principles of GMP
PREMISES
EEC 1.3
Specifically Annexe 1 Sterile Manufacture
WHO Chapter 1 .12
HVAC
Chapter 3 Sterile Manufacture.
Eudralex Monograph
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

10. World Health Organization
24 April, 2017
Basic Principles of GMP
EQUIPMENT
EEC 3 and 5 (production)
Specifically Annexe 1 Sterile Manufacture
WHO Chapter 1 (includes HVAC) Chapter 3 Sterile
Manufacture.
Eudralex Guideline. Also Sterile Manufacture.
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

11. World Health Organization
24 April, 2017
Basic Principles of GMP
CARE and MAINTENANCE
EEC 3.34 to 3.44 Cleaning and maintenance.
WHO 1.13
Company SOP for service schedule and pre programmed
Maintenance (PPM)
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

12. World Health Organization
24 April, 2017
Basic Principles of GMP
WRITE PROCEDURES
Addressed in the Documentation chapters of the guidelines
EEC 4.19 to 4.29
Include but not limited to
Inventory control
Sampling
Testing and status control
Manufacture and packaging
Hygiene /environmental monitoring & control
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

13. World Health Organization
24 April, 2017
Basic Principles of GMP
WRITE PROCEDURES
Addressed in the Documentation
chapters of the guidelines
WHO 1.15
Eudralex
PIC Annexe 13
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

14. World Health Organization
24 April, 2017
Basic Principles of GMP
VALIDATION
Validation protocols usually have a
generic format #
See WHO 1 appendix 6
Validation Master Plan
PIC guideline 10063
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

15. World Health Organization
24 April, 2017
Basic Principles of GMP
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”
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

16. World Health Organization
24 April, 2017
Basic Principles of GMP
TRAINING
WHO 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
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

17. World Health Organization
24 April, 2017
Basic Principles of GMP
RECORDS
Found in the documentation chapters of
the guidelines.
Examples
Analytical test records
Batch manufacturing documents (BMR)
Cleaning records
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

18. World Health Organization
24 April, 2017
Basic Principles of GMP
CLEANLINESS AND HYGIENE
Fleeting reference in EEC and WHO
Guidelines
PIC gives better information #
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

19. World Health Organization
24 April, 2017
Basic Principles of GMP
QUALITY
Quality Assurance
Both OG and WHO describe in detail the
elements of a robust quality system.
Emphasises its all embracing function
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

20. World Health Organization
24 April, 2017
Basic Principles of GMP
QUALITY
Quality Control
Quality control of raw materials
Components
Intermediates and finished products.
Microbiology
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

21. World Health Organization
24 April, 2017
Basic Principles of GMP
QUALITY
Quality Control
WHO EEC 12.6
Quality control of raw materials
Components
Intermediates and finished products.
Microbiology
$ #
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

22. World Health Organization
24 April, 2017
Basic Principles of GMP
AUDITING FOR COMPLIANCE
WHO 1.8
EEC2.9
Describes the procedures
Aspects of pharmaceutical production to be
assessed.
Includes audits of suppliers.
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

23. Basic Principles of GMP
World Health Organization
Basic Principles of GMP
24 April, 2017
So what else is there?
???
ISO9000
GAMP
HTM 2010 Validation
of Autoclaves
BS 6001
Notes: 45

24. World Health Organization
24 April, 2017
Basic Principles of GMP
OTHERS
ISPE Publications on good
Pharma Practice
HTM 2010 Validation of
Autoclaves
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

25. World Health Organization
24 April, 2017
Basic Principles of GMP
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
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

26. World Health Organization
24 April, 2017
Basic Principles of GMP
WHAT ELSE IS THERE
Complaints
Recalls
Returns
Stability programmes.
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)

27. World Health Organization
24 April, 2017
Basic Principles of GMP
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.
In this session, we are going to deal with an area of importance to the good functioning of a pharmaceutical factory, and look specifically at practices that are considered to be "good" in the production and quality control environment
This will be a quarter-day session with the following approximate timings:
Presentation 45 minutes
Group session 45 minutes
Group feedback minutes
(Timings are approximate and should be adjusted to suit the class and the course structure.)