uemb 3213 - lecture 14

http://www.utar.edu.my/fes

UNIVERSITI TUNKU ABDUL RAHMANFaculty of Engineering and Science

Prepared by:-

CHONG Yu Zheng [email protected]://staff.utar.edu.my/chongyz/uemb3213

UEMB 3213Safety Design in Medical

Devices

Lecture 14

Trimester 1, January 2009

2

UEMB 3213 - Safety Design of Medical Devices (Lecture 14)

THIS MODULE

• Module 3 –Device Safety Programs and Ethics– Good Laboratory Practice (GLP)– Good Clinical Practice (GCP)– Good Manufacturing Practice (GMP)


3

UEMB 3213Safety Design in Medical Devices

Module 3 –Device Safety Programs and Ethics

Quality Systems -Good Manufacturing Practice and the

Quality System Regulation



4


LECTURE LEARNING OUTCOMES

• At the end of this module, you should beable to– Provide an overview of the elements of Good

Manufacturing Practice (GMP) and the QualitySystem Regulation (QSR)

– Discuss the differences between GMP andQSR

– Explain why GMP and QSR are required andhow they are carried out in a medical devicecompany


5


INTRODUCTION TO GMP



6

INTRODUCTION TO GMP

• This module explores the concepts of GoodManufacturing Practice (GMP) and QualitySystem Regulation (QSR)

• The acronym “GMP” (Good ManufacturingPractice) is used internationally to describe aset of principles and procedures which, whenfollowed by manufacturers of medicaldevices, helps ensure that the productsmanufactured will have the required quality



7

INTRODUCTION TO GMP

• A basic tenet of GMP is that quality cannotbe tested into a product but must be builtinto each device during all stages of themanufacturing process

• The USA Food and Drug Administration(FDA) first formally issued GMP in 1978although it had been practised by drugand device manufacturers for many yearsbefore then



8

INTRODUCTION TO GMP

• There are several basic requirements outlinedby GMP and these are

– All manufacturing processes must be defined andvalidated

– Facilities must be provided with– Appropriately trained personnel– Adequate premises and space– Suitable equipment and services– Correct materials, containers and labels– Approved procedures and– Suitable storage and transport



9

INTRODUCTION TO GMP

• There are several basic requirementsoutlined by GMP and these are– Specific, clear, unambiguous procedures

written in instructional form must be developedand used

– Operators must be trained to carry out theprocedures correctly

– Records must be kept which demonstrate thatall steps were taken and that the quantity andquality produced were those expected



10

INTRODUCTION TO GMP

• There are several basic requirementsoutlined by GMP and these are– Records must be retained which enable

complete history of a batch to be traced– A system must be available for recall if

required



11

INTRODUCTION TO GMP

• These principles outline basic commonsense in manufacturing andimplementation of the principles of GMPallows quality to be built into the productduring manufacture

• The main disadvantage of GMP was thatits principles only covered themanufacture of medical devices



12

INTRODUCTION TO GMP

• In the late 1980’s, the FDA began to analysedata relating to the recall of medical devicesin the USA

– They found that 44% of voluntary recall actionsfrom were due to errors or deficiencies that hadoccurred in the design of the devices

– They found that manufacturers had failed> To properly identify and establish adequate

physical and performance requirements for devicesbefore production,

> to verify that devices met physical and performancerequirements before production,



13

INTRODUCTION TO GMP

• In the late 1980’s, the FDA began to analysedata relating to the recall of medical devicesin the USA

– They found that manufacturers had failed> to ensure that device components functioned

properly in conjunction with other components,> to ensure that the environment would not adversely

affect the components and to select adequatepackaging materials

– They also found that over 90% of recent softwarerelated recalls were due to design related errors,generally failure to validate software prior toproduction



14

INTRODUCTION TO GMP

• In short, the FDA found that a largeproportion of faults in the field related todesign related issues rather thanmanufacturing issues where the effect ofGMP was primarily concentrated

• They also found that these design relatedissues could have been prevented withappropriate design controls



15

INTRODUCTION TO GMP

• During this period, the ISO 9000 series ofstandards was being developed in Europe– These standards encompassed quality system

management as a whole and alsoincorporated elements of design control

– Consequently, in 1993, the FDA began therevision of the original GMP to add designcontrols and to harmonise to some degreewith the European ISO 9000 standards



16

INTRODUCTION TO GMP

• By 1995, a working draft of the new GMPwas published and in 1997, the revisedGMP was released and officially called theQuality System Regulation (QSR)

• QSR came into effect in the USA on June1, 1997 with a one year transitionprogramme for design controlrequirements



17

INTRODUCTION TO GMP

• Nowadays, compliance with GMP/QSR isused by most countries as the basis forthe licensing of manufacturers of medicaldevices and the remainder of this modulewill concentrate on QSR and itsimplementation

• Remember that QSR includes all theprinciples of GMP as well as a range ofother requirements to ensure the quality ofthe device



18


THE QUALITY SYSTEMREGULATION (QSR)



19

THE QUALITY SYSTEM REGULATION(QSR)

• The requirements of QSR are described inPart 820 of Title 21 of the Code of FederalRegulations (CFR)

• In general terms, the aim of QSR is toensure that the design, manufacture anddistribution of medical devices have aQuality Management Focus



20


• It is implemented to ensure the quality ofthe device, where quality is the totality offeatures and characteristics that bear onthe ability of a device to satisfy fitness foruse, including safety and performance,effectiveness, reliability and identity



21


• QSR is a harmonisation of GMP withISO9001 and ISO 13485 (the internationalstandard developed to take into accountthe particular requirements of themanufacture of medical devices)



22


• Over and above the requirements of GMP,QSR requires that– Each manufacturer shall establish and

maintain a quality system that is appropriatefor the specific medical devices(s) designedand/or manufactured,

– Specifications and controls must beestablished for devices,

– Devices must be designed under a qualitysystem to meet the specifications,



23


• Over and above the requirements of GMP,QSR requires that– Devices must be manufactured under a quality

system,– Finished devices must meet the specifications,– Devices must be correctly installed, checked

and serviced,– Quality data must be analysed to identify and

correct quality problems and– Complaints must be processed appropriately



24

ELEMENTS OF QSR

• QSR includes requirements related to themethods used in, and the facilities andcontrols used for all processes related tothe design, manufacture, sales and aftersales service of medical devices intendedfor human use



25

ELEMENTS OF QSR

• QSR covers the following aspects– Design– Manufacture including packaging, labelling

and storage– Installation and servicing



26

ELEMENTS OF QSR

• In detail, the regulation covers thefollowing areas– Quality management and organisation– Device design and development– The control of buildings and equipment– The purchase and handling of components– Production and process controls– Packaging and labeling controls



27

ELEMENTS OF QSR

• In detail, the regulation covers thefollowing areas– Device evaluation– Distribution– Installation– Complaint handling– Servicing and– Maintenance of records



28

ELEMENTS OF QSR

• You can see that QSR provides a systemwhich controls all aspects of a medicaldevice company’s operations fromproduct development through to servicingthe equipment at the customer’s premisesand handling complaints from the field



29

NEXT LECTURE

• 21 CFR 820 - QUALITY SYSTEMREGULATION


uemb 3213 - lecture 14

Documents

gmp andqsr

basic tenet of gmp

device safety programs

medical devicesmodule

medical devicesintroduction

medical devicecompanytrimester

module module

lecture learning outcomes