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DOC1909118
12 October 2016
1 (7)
Ondina Åsberg, Regulatory Support Leader
Sandi Hansen, Customer Support Manager
Karen Kiefer, Quality Director
Standard for GEHC Life Sciences
Change Control process for
Designated HyClone products
For External Use
GE Healthcare
Bio-Sciences
Björkgatan 30
SE-751 84 Uppsala
Sweden
05.000_Standard for
GEHC Life Sciences Change Control Process for
Designated HyClone Products
Content
Page
1.
Introduction .............................................................................................. 2
2.
Purpose ..................................................................................................... 2
3.
Scope ........................................................................................................ 2
4.
Definitions ................................................................................................ 2
5.
Steering principles .................................................................................. 3
6.
Risk Management of change .................................................................. 3
7.
7.1
7.2
7.3
Customer notification .............................................................................. 3
Notification of changes to this document ................................................... 3
HyClone Cell Culture Standard Products .................................................. 4
Discontinuation Policy ................................................................................ 4
8.
8.1
Subscription to change notification ...................................................... 4
Notification content .................................................................................... 5
9.
Flow chart ................................................................................................. 5
10.
Document Owner ..................................................................................... 6
11.
Revision History ...................................................................................... 6
1. Introduction
A process for change control is required for suppliers to the Biopharmaceutical
industry.
As a supplier of products often used in a GMP environment, GEHC Life Sciences has
acknowledged that Change Control is a critical process in the quality management
system and necessary to fulfil the obligations to supply products with a consistent
quality to our customers.
2. Purpose
The purpose of this document is to provide an overview of the change control process
for designated products within GEHC Life Sciences.
Detailed procedures and instructions that are in compliance with this document are
used at the local GEHC sites and can be reviewed during audits.
This document may be used externally to introduce the Life Sciences Quality
Management System to customers or other external organizations or individuals.
3. Scope
This standard applies to HyClone products that are available for subscription to
change control notifications and thus are listed on the web page:
www.gelifesciences.com/rsf.
4. Definitions
Change control: Management of all planned changes associated with the
manufacturing of marketed products.
Product quality: The product characteristics that are listed in the product
specification.
Critical subcontractor: Contract manufacturer of critical raw material, product or
process.
Design changes: Any modification to a product that may impact design form, fit or
function.
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05.000_Standard for
GEHC Life Sciences Change Control Process for
Designated HyClone Products
5. Steering principles
Each manufacturing unit is following a change control procedure and change requests
are assessed by a global change control board. The change control review board has
representatives from quality assurance, R&D, manufacturing and other relevant
functions. The representatives must be on an organizational level that gives authority
to take decisions.
The board is responsible for:
 assessing all aspects of proposed changes
 assessment of output from the impact assessment
 deciding on the extent of verification/validation
 review and approval of design and manufacturing changes
6. Risk Management of change
Major changes are evaluated regarding product quality from a risk perspective.
When a potential hazard is identified measures are taken to reduce the risk to an
acceptable level. An impact assessment is performed for every major change.
Verification/validation can be performed as a part of the change management to
assure that the process is consistent.
7. Customer notification
Changes subject to customer notification:
For changes listed below in points 7.1-3, customers are always notified.
Notification is given for products available for subscription to change control
notifications listed on the web page www.gelifesciences.com/rsf, according to the
below description.
The time frames in sections 7.1 through 7.3 are an estimate which GE Healthcare
aims to fulfil. However, there may be situations due to external or internal factors
where GE Healthcare may have to inform with shorter notices, and GE Healthcare
reserves the right to inform with shorter notice than described below in situations when
non-standard events occur.
7.1 Notification of changes to this document
New edition of this change control standard will be notified minimum 3 months prior to
implementation.
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05.000_Standard for
GEHC Life Sciences Change Control Process for
Designated HyClone Products
7.2 HyClone Cell Culture Standard Products
Changes for which notification is given a minimum of 1 month prior to implementation:
(Minor change: A change in documentation, specifications, processing, or product
handling procedures that does not affect the form, fit or function of the product.)
Changes for which notification is given a minimum of 3 months prior to implementation:
(Major change: Significant change to the facility, equipment, manufacturing process, or
a subcomponent, which could result in a change to the form, fit or function of the
product.)
Notifiable changes:
 Changes in formula, content, or make-up of a given liquid, powder or serum
product.
 Changes in product contact materials (primary packaging)
 Changes in packaging construction or configuration which will impact customer’s
storage and unpacking processes
 Changes in manufacturing methods with affect the form, fit or function of the
finished product
 Changes in testing methods or relaxation (broadening) of release criteria for
finished product
 Changes to, or removal of, significant label or Certificate of Analysis information
such as finished product description, quantity or volume, lot number, manufacture
or expiration date, manufacturer’s name or location, or intended use statement
 Changes of content to finished product specifications which affect form, fit, or
function for finished products.
 Change/ addition of manufacturing location for finished products
 Product deletion or phase out
 Changes in subcontractors for production of finished or intermediate product
 Changes in storage location or conditions for finished products
 Change to legal entity
All supply, quality and/or change agreements for standard cell culture products supersede the above notification
requirements. All customer change notifications will be delivered per the terms of the negotiated and approved
agreements (not uploaded to the web site)
7.3 Discontinuation Policy
Should GE Healthcare decide to discontinue any standard HyClone product,
customers registered for Change Control Notifications for that product and have
purchased the product shall be notified at least 1 year in advance. However, there
may be situations due to external or internal factors where GE Healthcare may have to
inform of a discontinuation with shorter notice. GE Healthcare reserves the right to
inform with shorter notice than described in situations when non-standard events
occur
8. Subscription to change notification
Customers can subscribe to notification of change control for the products listed on
the webpage below. Registration at the Regulatory Support web page
www.gelifesciences.com/rsf is required for notification. At the web page registrants
must select each product to which notification is requested.
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05.000_Standard for
GEHC Life Sciences Change Control Process for
Designated HyClone Products
8.1 Notification content
The notification contains the following information:
 Identity of product (product name, article/code number)
 description of the change
 reason for change
 supporting data (when applicable)
 updated specification when applicable
 time line for the change
9. Flow chart
Flowchart for the change control procedure.
Request for
change – basic
data including
output from the
risk managment
process
Change control
review board
meeting
Requested
change
approved?
No
Yes
Is notification
required?
Change control
Review board
minutes
Yes
No
Generate
Notification
letter
Notification letter
to customer
Implementation
of change
Change
documentation
Archiving
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05.000_Standard for
GEHC Life Sciences Change Control Process for
Designated HyClone Products
10. Document Owner
Customer Regulatory Support Leader
11. Revision History
Revisi
on
Numb
er
Section(s) Changed
Changes
01
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