Handbook on the application of ISO 13485:2016

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Transcript Handbook on the application of ISO 13485:2016

IFF’s ERFA gruppe
for combination products
Risk Management
15. sept. 2016 /Ingrid Malmberg
Intro til Risk Management and risk based
• Gruppearbejde
• Pause
• Præsentation af gruppearbejde
• Erfaudveksling
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EU Directives
EudraLex Volume 4 Good
Practice (GMP)
Medical Devices
In Vitro
Diagnostic (IVD)
Medical Devices
Regulation (EC)
No 1223/2009
on Cosmetic
Medical Devices
ISO 13485:2016 Medical Devices - Quality
Management Systems – Requirements for
regulatory Purposes
ISO 22716
Cosmetics - Good
Practice (GMP)
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Combination Products in Europe
No designated regulation for Combination Products in Europe and no designated
agency, but….
Medical devices incorporating, as an integral part, an ancillary medicinal
substance: Medical devices may be assisted in their function by pharmacological,
immunological and metabolic means but with primary mode of action as mechanical
The quality, safety and usefulness of the substance must be verified by analogy with
the methods specified in Annex I to Directive 2001/83/EC
Drug-delivery products regulated as medicinal products or medical devices:
This category involves a device that is intended to administer a medicinal product.
The safety and intended use of the device must be verified by analogy with methods
specified in Annex I (Essential Requirements) to Directive 93/42/EEC
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Combination Products according to FDA
21CFR, Part 3 – Product Jurisdiction, §3.2 Definitions.
A product comprised of two or more regulated components, i.e.,
that are physically, chemically, or otherwise combined or mixed and produced as a single
entity. Single entity combination product.
Two or more separate products packaged together in a single package or as a unit and
comprised of drug and device products, device and biological products, or biological and
drug products. Co-packaged combination product.
Cross-labeled products. The components are separately provided but labeled for use
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21CFR, Part 4: cGMP for combination products
If the operating manufacturing control system is Part
820 (Quality System Regulation) compliant
Additional CGMP
If the operating manufacturing control system is Part
210/211 (cGMP regulation) compliant
Additional QS
Testing and approval or rejection of
components, drug product
containers, and closures
Management responsibility
Calculation of yield
Design controls
Tamper-evident packaging
requirements for over-the counter
(OTC) human drug products
Purchasing controls
Expiration dating
Corrective and preventive action
Testing and release for distribution
Stability testing
Special testing requirements
Reserve samples
Including all subsections, as appropriate
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21CFR part 4, cGMP Requirements for Combination
Products, FDA’s Draft Guidance January 2015
Design Control.
21CFR 820.30(g) requires that the manufacturer complete risk analysis, where
appropriate, which should begin early in the design process and continue throughout
the lifecycle for the product.
Risk analysis should be completed on the combination product as a whole to
identify risks associated with its design, manufacturing processes, and
intended use.
Some risks may be identifiable during initial design development and addressed in
design inputs, while others may become apparent based on postmarket experience
(including adverse event reporting) and used to determine whether any aspects of the
design should be adjusted or revised. Any unacceptable risk(s) should be reduced or
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ISO 13485:2016,
4 Quality Management System,
4.1 General requirements
4.1.2 The organization shall:
Determine the processes needed for the quality management system and the
application of these processes throughout the organization taking into account the
roles undertaken by the organization;
Apply a risk based approach to the control of the appropriate processes needed
for the quality management system;
Determine the sequence and the interaction of these processes.
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ISO 13485:2016,
4 Quality Management System,
4.1 General requirements
4.1.3 For each quality management system process, the organization shall:
Determine the criteria and methods needed to ensure that both the operation and
control of these processes are effective;
Ensure the availability of resources and information necessary to support the
operation and monitoring of these processes;
Implement actions necessary to achieve planned results and maintain the
effectiveness of these processes
Monitor, measure as appropriate, and analyze these processes
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Handbook on the application of ISO 13485:2016 – What
to do – Guidance from ISO/TC 210 (Draft, April 2016)
Having identified the processes needed for the quality management system, and the
risks associated with that process, the organization can look in detail at each process.
There are some essential elements that need to be addressed for each process.
These can be addressed by considering the following questions:
How will the organization know whether the process is effective?
What controls are necessary to monitor the process?
How will the outputs of the monitoring be analyzed?
Who is responsible for the process and what competence requirements are there
for the position(s)?
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ISO 13485:2016
7 Product realization
7.1 Planning of product realization
The organization shall document
one or more processes for risk
management in product
realization. Records of risk
management activities shall be
Indsæt figuren fra ISO std.
Note: Further information can be found
in ISO 14971: Application of Risk
Management to Medical Devices
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Eudralex, volume 4, part III
Quality Risk Management (ICH Q9)
The text of this document, formerly Annex 20, remains optional and provides some
examples of the processes and applications of Quality Risk Management.
This guideline provides principles and examples and tools for quality risk
management that can be applied to different aspects of pharmaceutical quality.
These aspects include development, manufacturing, distribution, and the
inspection review processes throughout the lifecycle of the product.
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Diskutér et risk based approach for én af følgende QMS processer:
Product Risk Management throughout product lifecycle
Change control for design changes
Corrective Actions & Preventive Actions
baseret på ISO handbooks spørgsmål
Forbered max 10 min. præsentation for de øvrige grupper.
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Ny lovgivning og guidelines
Myndighedsinspektioner vedr. kombinationsprodukter
Kurser og konferencer, både før og efter deltagelse
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