Design Controls & Ancillary Processes 21 CFR, Part 820.30

112 Pages·2012·0.53 MB·English

OMTEC 2012
MidWest Process Innovation, LLC
Design Controls
& Ancillary Processes
21 CFR, Part 820.30
ISO 13485:2003, Section 7.3
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 1
Full Quality System…..Application Approach
The FDA requires that domestic or
foreign manufacturers have a quality
system for the design and
production of medical devices
intended for commercial distribution
in the United States
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 2
Scope…..Device Life Cycle…..
The QS regulation is in Part 820 of Title 21 of the Code of
Federal Regulations (CFR). This regulation covers (at
least):
•quality management and organization,
•device design,
•auditing
•training
•purchasing controls / acceptance activities
•production and process controls and ancillary processes,
•packaging and labeling control,
•device evaluation,
•handling, storage, distribution,
•corrective action and preventive action
•non-Conformances
•complaint handling,
•servicing and installation
•document control and records
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 3
Justify…..Document…..Authority
If manufacturers decide to not implement
certain GMP requirements which are
qualified by the term "where appropriate,"
they should document their justification
for non-implementation. The justification
should show that not implementing a
requirement is not reasonably expected to
result in product that does not meet
specifications [820.1(a)(30].
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 4
Quality System…..Documents…..Fast Track Design
It is left to manufacturers to
determine the necessity for, or
extent of some quality elements and
to develop and implement specific
procedures tailored to their
particular processes and devices.
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 5
820.20(d)…..Mgmt. Review…..Core Competency
It is left to the manufacturer to
determine the best methods to
attain quality objectives. In some
cases, however, the QS regulation
does specify the particular type of
method to be used, such as written
procedures or written instructions.
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 6
Electronic Records...Software Validation...Preamble
Written procedures are not restricted
to paper copies. Written procedures
may be filed and distributed by
automated data processing
equipment.
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 7
Mgmt. Review…..QRB…..QSRB…..Improvement
After a manufacturer establishes a
quality system, it should be
maintained. Each manufacturer
should assure that with growth and
process or product changes their
quality system is still adequate
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 8
Change Control (generally)…..Auditing…..Authority
This assurance is obtained through change
control, daytoday observance of operations, and
by periodic audits of the quality system. The
auditor should first identify the elements of the
company's quality system. Next the audit should
determine how well each element is functioning,
and then determine its adequacy with respect to
the intent of the device GMP requirements and
meeting the company's quality claims.
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 9
Exemptions…...Design Controls…..Finished Devices
The QS regulation applies to finished
devices intended to be commercially
distributed for human use unless
there is an approved exemption in
effect. GMP exemptions are codified
in the classification regulations 21
CFR 862 to 892.
©Copyright, 2012, MPI, LLC www.midwestprocessinnovation.com 10