GAMP 5 and the supplier

GAMP 5 and the Supplier

Leveraging supplier advantage out
of compliance

Paul Osborne
Performance PharmaTech Ltd.
GAMP 5 and the supplier

Overview

• This document is designed to assist suppliers who wish to sell

computer based equipment into the highly regulated
pharmaceutical environment. It describes the details of
validation for those who are new to the subject and describes
the development of a suitable documentation set that we refer
to as the pre-validation documentation set.

• This pre-validation documentation set should be supplied to the

pharmaceutical company along with or shortly after the
equipment, this way the company can begin the validation
immediately. Part of the pre-validation set can also be offered at
product release, as the product release documentation set

• Remember that the validation process must occur before the

end customer can product drug; therefore the pre-validation
documentation set is as important to the end customer as the
equipment itself.
GAMP 5 and the supplier

Overview

• A salesman is often reluctant to bring up the subject of

validation!

• So in many cases I have observed this issue does not arise

until the equipment is actually due for delivery and then the
arguments can begin over increasing costs and slipping
schedules

• This can be avoided if the subject is broached at an initial sales

project meeting with the customer or OEM representative. They
may not know the details of the requirements but they will
contact the relevant person within the end company and that
will begin the process
GAMP 5 and the supplier

Overview

• The supplier has an important role in providing equipment that

can be validated. If the customer cannot validate the
equipment it is of no use to them. More than this, the
equipment should be easy to validate and have the
documentation to support this operation

• Different pharmaceutical companies have different ways of

validating equipment, so this sounds like the supplier has a
difficult or impossible job in supplying documentation.

• This is just not the case. Once the rules are understood then
the supplier can be of help to all customers and everyone will
be satisfied
GAMP 5 and the supplier

Overview

• Also – do not be afraid of telling the end customer or OEM the

validation costs. It would cost the pharmaceutical company far
more to have a validation consultant, who is not familiar with the
equipment, perform this work. By leveraging know-how the
pharmaceutical company helps itself

• So it is more cost effective for the supplier to make the pre-

validation pack than anyone else and this can be used this as a
sales tool

• Remember that the support can be just the documentation set,

or providing assistance with the testing

• I emphasise assistance because the supplier is not responsible

for the testing, the end customer is and it is he who will report in
any regulatory audit, not the equipment supplier
GAMP 5 and the supplier

Overview

• GAMP guidance aims to achieve computerised systems that

are fit for intended use and meet current regulatory
requirements, by building upon existing industry good practice
in an efficient and effective manner

• It is not a prescriptive method or a standard, but rather provides

pragmatic guidance, approaches and tools for the practitioner

• When applied with expertise and good judgment, this guide

offers a robust, cost effective approach

– Introduction to GAMP 5 guide

GAMP 5 and the supplier

Overview

GAMP 5 is an accepted source of guidance for regulators and

practitioners worldwide:

• ICH Guidance Q8, Q9 and the forthcoming Q10

• FDA Good management practices
• PIC/S guidance on good practices for computerised systems
• ASTM E55 committee on drug development and manufacture

Therefore manufacturing companies worldwide have accepted

GAMP methodology and used it in their policies
GAMP 5 and the supplier

Key Concepts

• Product and process understanding

• Life cycle approach within a QMS
• Scalable life cycle activities
• Science based quality risk management
• Leveraging supplier involvement

– GAMP 5 guide
GAMP 5 and the supplier

Overview
GAMP 5 and the supplier

Key Concepts

• Regulated Pharmaceutical companies should seek to maximise

supplier involvement throughout the system life cycle in order to
leverage knowledge, experience and documentation, subject to
a satisfactory supplier assessment

• The supplier may assist with requirement gathering (URS), risk

assessment, the creation of functional and other specifications
(FS), system configuration (IQ), testing (OQ), support and
maintenance

– GAMP 5 guide
GAMP 5 and the supplier

Key Concepts

• Justification for the use of supplier documentation should be

provided by the satisfactory outcome of supplier assessments,
which may include supplier audits

• Documentation should be assessed for suitability, accuracy and

completeness. There should be flexibility regarding acceptable
format, structure and documentation practices

– GAMP 5 guide
Packaging Lines – Control and Validation

• The more that standard software is used and the less

customisation made for such software the less testing is
required by individual users. GAMP has developed software
categories based on the level of customisation. In total there
are four categories defined in GAMP 5. We are usually
concerned with category 4

Category Description

3 Standard software package. No customization.

Examples: MS Word (without VBA scripts). Computer controlled spectrophotometers.
Temperature and Humidity controllers. Older barcode readers.
4 Standard software package. Customization of configuration.
Examples: LIMS, Excel spreadsheet application where formulae and/or input data are
linked to specific cells. Networked data systems. PC Based Machine Control systems.
Machine vision systems.
5 Custom software package. Either all software or a part or the complete package has
been developed for a specific user and application.
Examples: Add-ons to GAMP Categories 3 and 4, Excel® with VBA scripts. Dedicated
and unique Machine control system using Industrial PC hardware. Vision systems
having PLC functionality.
Packaging Lines – Control and Validation

• A GAMP 5 level 4
category system, where
the system is a standard
Hardware and Software
product that is in serial
production and only
configuration is needed to
make it operational

• Phases like design

specification or code
development and code
testing are not necessary
provided that adequate
design and testing
documentation exists for
the system
Packaging Lines – Control and Validation
User / System
Requirements

• The 4 Step model is not suitable

when systems need to be Functional
Specification
Request for
Proposal
programmed for specific
applications or when additional Design
Verification of
vendors
software is required that is not Specification
specification

included in the standard product Code development Finalise

and is developed by the user’s And Review Requirements

firm or by a 3rd party

Unit, Integration Vendor
And System testing assessment

• This means that the system

immediately moves into a GAMP IQ

5 level 5 category system. In

this case a life cycle model that OQ
combines system development
and system integration is PQ
preferred
Maintenance, use
And Retirement
GAMP 5 and the supplier

So what can a company supply as a package to the

end customer or OEM? to support GAMP 5 level
4, configurable computer systems?

• Dedicated FS and IOQ documentation set. The type

of system supplied decides how generic or
dedicated this documentation set must be

• Please note that the FS this is the application FS

GAMP 5 and the supplier

• QMS system overview

• Specifications for the design - equipment design FS or

minimum installation documentation

• Design review details. Sometimes called a Design Qualification

(DQ)

• Software configuration

• Testing of the system – or reference that documentation can be

viewed
GAMP 5 and the supplier

• User documentation

• Training details

• CE marking documentation

• System support - details of the your system of software release

documentation - defining fixes, changes and new features. Any
system for customer notification of problems

• Reference to results of an audit, including source code review,

made by an independent and qualified auditor on your
company and its major sub-suppliers
GAMP 5 and the supplier

Recommended documentation set:

• Computer system validation - GAMP 5 level 4

definitions – © PPtech

• Supplier system validation – © PPtech

• Company Audits – © PPTech

• GAMP 5 Guide – Available from ISPE

GAMP 5

Thank you for your attention.

Find us and your
documentation at:

www.pptech.eu