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Annex 1 Revision: Greg Mcgurk, GMP Manager (Acting)
Annex 1 Revision: Greg Mcgurk, GMP Manager (Acting)
GMP Conference
7 February 2017
Dublin
History
07/02/2017 2
Rationale for Revision
Needed “Tidying up”
New technologies:
• Reinforcing the need of manufacturers to keep up with current technologies
• Single use closed systems
• Disposable systems
• Innovative technologies
• Some ambiguities
07/02/2017 3
Annex 1 update
Section Number General overview
1.Scope Additional areas (other than sterile medicinal products) where the general
principles of the annex can be applied
3. Pharmaceutical Highlights the specific requirements of the PQS when applied to sterile medicinal
Quality System (PQS) products
4. Personnel Guidance on the requirements for specific training, knowledge and skills. Also
gives guidance to the qualification of personnel
5. Premises General guidance regarding the specific needs for premises design and also
guidance on the qualification of premises including the use of barrier technology
6. Equipment General guidance on the design and operation of equipment
7. Utilities Guidance with regards to the special requirements of utilities such as water, air
and vacuum
07/02/2017 4
Annex 1 update
Section Number General overview
7. Utilities Guidance with regards to the special requirements of utilities such as water, air
and vacuum
8. Production and Discusses the approaches to be taken with regards to aseptic and terminal
specific technologies sterilisation processes. Also discusses different technologies such as single use,
lyophilisation and BFS / FFS where specific requirements may be required.
Discusses approaches to sterilization of products, equipment and packaging
components
9. Viable and non viable This section differs from guidance given in section 5 in that the guidance here
environmental and applies to ongoing routine monitoring with regards to the setting of alert limits
process monitoring and reviewing trend data
07/02/2017 6
Annex 1 update – 2. PQS
Reinforce the existing requirements of EU GMP
EU Directive 2003/94 Article 5
EU Directive 2001/83 Article 23
Chapter 3
Chapter 5 (5.10)
QRM application, alternative at least as good as the stated objective
RCA & Product Impact Assessment
07/02/2017 7
Annex 1 update – 5. Personnel
Training/knowledge
07/02/2017 8
Annex 1 update – 6. Premises 7. Equipment
Design
QRM application
Again reinforcing the need to keep the operators away from the product using current technology
Disinfection – Efficacy
07/02/2017 9
Annex 1 update – 8. Utilities
General services such as compressed air
WFI by RO - Possibility that this could then be moved to a separate section of the
GMPs
Biofilms
Cooling systems
Steam
07/02/2017 10
Annex 1 update – 9. Production and Specific technologies
Blow Fill Seal
Form Fill Seal
Sterilisation Process & Controls
Aseptic Preparation
Finishing
Filtration – Pre-Use Post Sterilisation Integrity Test
Lyophilisation
Closed Systems
Single Use Technology
07/02/2017 11
Annex 1 update – 10. Environmental Monitoring
07/02/2017 12
Annex 1 update – 10. Environmental Monitoring
Reinforce the development of the “system” by risk assessment – process inputs, processes, operations / activities
5.0 µm particles
07/02/2017 13
Annex 1 update
• 11. Quality Control
• 12. Glossary
07/02/2017 14
Annex 1 update - Progress
Joint working group between PIC/S and EMA
Two rounds of review - circulated to PIC/S and IWG Mid 2016 & November 2016
07/02/2017 15
Questions