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

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Related Guidelines John Startup Good Practices in Production and Quality Control Related Guidelines JOHN STARTUP Training workshop: Training workshop on regulatory ... – PowerPoint PPT presentation

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Title: Good Practices in Production and Quality Control. Related Guidelines John Startup


1
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
Basic Principles of GMP
Good Practices in Production and Quality Control.
Related Guidelines
3
Basic Principles of GMP
The Ten Commandments of GMP
Section 16 and 17
4
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

Section 16 and 17
5
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.

6
Basic Principles of GMP
The WHO Guidelines EEC Guidelines(ORANGE
GUIDE Eudralex Guidelines FDA Guidelines(CFR) MHRA
Specific Topics
7
Basic Principles of GMP
Well documented and respected guidelines. Most
available on the internet (OG is the exception)
8
Basic Principles of GMP
Do not forget EP, BP,USP Setting standards as
opposed to guidelines
9
Basic Principles of GMP
PREMISES EEC 1.3 Specifically Annexe 1 Sterile
Manufacture WHO Chapter 1 .12 HVAC Chapter 3
Sterile Manufacture. Eudralex Monograph
10
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.
11
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)
12
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

13
Basic Principles of GMP
WRITE PROCEDURES Addressed in the Documentation
chapters of the guidelines WHO 1.15 Eudralex PIC
Annexe 13
14
Basic Principles of GMP
VALIDATION Validation protocols usually have a
generic format See WHO 1 appendix 6 Validation
Master Plan PIC guideline 10063
15
Basic Principles of GMP
VALIDATION
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