This document discusses concepts regarding the GAMP Guide. It provides an overview of key terms like GAMP and GMP. It outlines the origin of the GAMP Guide in the early 1990s to improve understanding of pharmaceutical regulation and validation. It describes the general validation process activities of planning, specifications, test planning, testing, and review. It explains the relationship between user requirements, functional specifications, design specifications, and the different qualification documents. Finally, it acknowledges the reader.

1. Concepts regarding
GAMP Guide
By Lorenzo Bergamini
On behalf of
www.bli.it

2. Index
Contents
Concepts regarding Terms
Origin of GAMP Guide
General Validation
G l V lid ti
Guide Process Activities
Relationship
Acknowledgements

3. Creative Commons
This document is provided under Creative
Commons License.
If used, indicate the source:
• Author’s name Lorenzo Bergamini
Author s
• On behalf of www.bli.it .

4. Terms
User : the Customer who
Good Automated contacts a supplier for a
GAMP Manufacturing Subjects product.
Practice Supplier : any
organization contacted
directly by the
di tl b th user f for
supplying a product.
Good Prospective
GMP Manufacturing Concept validation.
Practice
Any standard,
standard To produce
configurable, custom, documented proof
Objects product or application. Objective ensuring that all parts
of the equipment in
question will work
correctly when used
used.

5. Origin of the GAMP Guide
In the early 90’s, with the increased complexity of
automated systems in the Pharmaceutical sector,
subsequently extended to the Biomedical, Chemical and
q y ,
Foodstuffs sector.
And the consequent need to improve understanding of the
regulation and its interpretation.
The GAMP Forum, guided by David Selby, promotes this
activity.
One of the priorities is to establish guidelines for suppliers
of automated equipment to the above mentioned sectors
above-mentioned sectors.

6. General
Validation Process Activities
Planning / Progettazione
Specification / Specifiche
Test Planning / Piano di Test
Testing / Test
Review / Revisione

7. General
Validation Process Activities
Planning
[progettazione]
Written Validation Plan
(Piano di Validazione).

8. General
Validation Process Activities
Specifications
[specifiche]
Specify and agree what is required.
required

9. General
Validation Process Activities
Test Planning IQ [installation qualification]
OQ [operational qualification]
[piano di test] PQ [performance qualification]
Prepare document to describe how the system is to be
tested.

10. General Validation Process
Activities
Testing IQ [installation qualification]
OQ [operational qualification]
[test] PQ [performance qualification]
Perform tests and collect results
results.

11. General Validation
G l V lid ti
Process Activities
Review
[revisione]
Review results to show that the system performs as
specified plus any reservations.

12. Relationship
The three main Test documents can be related to the three basic levels of features of the system
built:
b ilt
User
Performance
Requirements
q
Related to Qualification
Specifications
Functional Operational
Specification Qualification
Design Installation
Specification Qualification
System
Build

13. Relationship
User
Performance
Requirements
Related to Qualification
Specifications
User Requirements Specification (URS)
Describes what An initial version is URS may be related
the system is included in the to Performance
required to do Invitation To Tender Qualification (PQ),
Q lifi ti (PQ)
and is normally (ITT), sent to potential which controls the
suppliers. The final system in its
written by the
version may be prepared operating
User.
User by h
b the selected supplier.
l d li environment, with
i t ith
all the associated
procedures.

14. Relationship
Functional Operational
Specification Related to Qualification
Functional specification (FS)
It is normally
written by the FS are related to
An initial version may
supplier and Operational
be produced in
describes the response to the ITT. Qualification (OQ),
detailed Further reviews are which controls all
functions of the prepared together with the specific
system. the User. functions.

15. Relationship
Design Installation
Specification Related to Qualification
Design Specification (DS)
It is a complete DS is related to
fairly detailed Installation
definition of the Design specification of Qualification (IQ),
Q lifi ti (IQ)
the system provided by which checks to
system so that it
the product make sure the exact
can be Supplier/Producer. system is supplied,
constructed.
constructed according to the
di t th
required standards
and that it is
installed correctly.

16. Qualification Document
Production
P d ti
The qualification document The supplier s documentation
supplier’s
can be produced and checking procedures can
satisfactorily when a already satisfy the
separate and complete
p p requirements of the IQ
q Q
specification already exists (Installation Qualification), if
for the process or system reviewed and approved by the
to which reference is made. User.

17. Acknowledgements

18. Acknoweledgements

19. Concepts regarding
GAMP Guide
By Lorenzo Bergamini
On behalf of Thank You!
www.bli.it