21 CFR 820.50

Report
How is the Supply Chain
Impacted by the FDA
Purchasing Controls Regulatory
Requirements?
Teresa Jimenez
Regulatory Expert Consultants, Inc.
Oct. 4, 2012
Overview
• QS regulatory requirements for Purchasing
controls (21 CFR 820.50)
• GHTF Guidance on the Control of Products and
Services Obtained from Suppliers
• Link between purchasing controls and other QS
regulation requirements
• W/L for Purchasing Control
2
General Provisions
Sub-Part 820.1 (a) Applicability
• QSR purports the basic requirements
applicable to manufacturers of finished
medical devices. In other words, QSR
clearly exposes
– What to do; but it doesn’t portray HOW to do it
• It does not apply to manufacturers of
components.
3
General Provisions
820.1(a) Applicability
The QS Regulation is intended to ensure that
finished devices will be
– SAFE
– EFFECTIVE, and
– WITHIN COMPLIANCE with the Federal Food
Drug and Cosmetic Act (the Act)
4
DEFINITIONS
• Finished Device: Any device or accessory to any
device that is suitable for use or capable of
functioning, whether or not it is packaged, labeled,
or sterilized.
• Component: Any raw material, substance, piece,
part, software, firmware, labeling, or assembly
which is intended to be included as part of the
finished, packaged, and labeled device.
5
DEFINITIONS
• Service means parts of the manufacturing or quality
system that are contracted to others, for example,
plating of metals, testing, and sterilizing, among others.
Preamble to the 1996 QS Regulation, Comment #102
• Manufacturing Material: Any material or substance
used in or used to facilitate the manufacturing process,
a concomitant constituent, or a byproduct constituent
produced during the manufacturing process, which is
present in or on the finished device as a residue or
impurity not by design or intent of the manufacturer.
6
General Provisions
820.1(c) Authority
The failure to comply with any applicable
provision of CFR 21 part 820 renders a
device adulterated under section 501(h) of
the act.
Such device, as well as any person
responsible for the failure to comply is
subjected to regulatory actions
7
MANUFACTURER’S
RESPONSIBILITY
820.5 Quality System
Each manufacturer shall establish and
maintain a Quality System that is appropriate
for the specific medical devices designed
or manufactured, and that meets the
requirements of part 820.
8
PURCHASING CONTROLS
Inadequate Purchasing Controls
Significant Number of Recalls
9
Regulation Scope
FDA decided not to regulate component
manufacturers under the Quality System
regulation in light of the new Purchasing
Controls Requirements in 820.5 and the
requirements for Receiving Acceptance
Activities in 820.80(b).
10
PURCHASING
CONTROLS OVERVIEW
•
Establish and maintain procedures to ensure that all
purchased or otherwise received product and services
conform to specified requirements
•
Evaluate suppliers, contractors and consultants
•
Establish and maintain purchasing data/documents that
describe or reference specified requirements (including
notification of change agreements)
•
Approve purchasing data/documents
11
PURCHASING CONTROLS
21 CFR 820.50
Each manufacturer shall establish and maintain
procedures to ensure that all purchased or
otherwise received product and services conform
to specified requirements.
Product includes components, manufacturing materials, inprocess devices, finished devices, and returned devices. [21
CFR 820.3(r)]
12
Internal/External Suppliers
... the requirements apply to all product and
service received from outside of the finished
device manufacturer, whether payment occurs or
not. Thus, a manufacturer must comply with these
provisions when it receives product or services
from its “sister facility” or some other corporate or
financial affiliate.
Preamble to the 1996 QS Regulation, Comment #100
★In general, entities not covered by a firm’s internal
audits should be treated as suppliers.
13
PURCHASING CONTROLS
21 CFR 820.50(a) Evaluation of suppliers,
contractors, and consultants.
Each manufacturer shall establish and maintain the
requirements, including quality requirements, that
must be met by suppliers, contractors, and
consultants.
Each manufacturer shall:
14
PURCHASING CONTROLS
21 CFR 820.50(a)(1)
Evaluate and select potential suppliers, contractors, and
consultants on the basis of their ability to meet specified
requirements, including quality requirements. The
evaluation shall be documented.
``quality requirements'' means the quality control and quality
assurance procedures, standards, and other requirements
necessary to assure that the product or service is adequate for
its intended use.
Preamble to the 1996 QS Regulation, Comment #109
15
PURCHASING CONTROLS
21 CFR 820.50(a)(2)
Define the type and extent of control to be
exercised over the product, services, suppliers,
contractors, and consultants, based on the
evaluation results.
★ higher risk components
★ higher risk processes (e.g., those that may require validation)
★ sub-tier supplier controls
16
PURCHASING CONTROLS
Risk Based Decisions
The extent of the specification detail necessary
to ensure that the product or service purchased
meets requirements will be related to the nature
of the product or service purchased, taking
into account the effect the product or service
may have on the safety or effectiveness of the
finished device, among other factors.
Preamble to the 1996 QS Regulation, Comment #115
17
Initial Supplier Assessment
... certification may play a role in evaluating suppliers, but
cautions manufacturers against relying solely on certification
by third parties as evidence that suppliers have the capability
to provide quality products or services.
...third party certification should not be relied
on exclusively in initially evaluating a supplier. If a device
manufacturer has established confidence in the supplier's
ability to provide acceptable products or services, certification
with test data may be acceptable.
Preamble to the 1996 QS Regulation, Comment #103
18
Supplier Assessment
• Each manufacturer must establish an appropriate mix of
assessment and receiving acceptance to ensure products
and services are acceptable for their intended uses. The
specifications for the finished device cannot be met
unless the individual parts of the finished device meet
specifications. The most efficient and least costly approach
is to ensure that only acceptable products and services are
received. This means that only suppliers, contractors, and
consultants that meet specifications should be used.
• Preamble to the 1996 QS Regulation, Comment #99
19
Supplier Assessment
...a finished device manufacturer may choose to provide greater in-house
controls to ensure that products and services meet requirements, or may
require the supplier to adopt measures necessary to ensure acceptability,
as appropriate. FDA generally believes that an appropriate mix of
supplier and manufacturer quality controls are necessary. However,
finished device manufacturers who conduct product quality control
solely in-house must also assess the capability of suppliers to provide
acceptable product.
Where audits are not practical, this may be done through, among
other means, reviewing historical data, monitoring and trending, and
inspection and testing.
Preamble to the 1996 QS Regulation, Comment #99
★
★
Link to Acceptance Activities – 21 CFR 820.80(a)
Be cautious of using prior supplier audits as sole basis for decisions; verify the
scope of previous audits.
20
Supplier Assessment
Suppliers, contractors, and consultants selected by
manufacturers of medical devices should have a
demonstrated capability of providing products and
services that meet the requirements established by the
finished device manufacturer.
The capability of the product or service suppliers should
be reviewed at intervals consistent with the significance
of the product or service provided and the review should
demonstrate conformance to specified requirements.
Preamble to the 1996 QS Regulation, Comment #105
21
Supplier Records
21 CFR 820.50(a)(3)
Establish and maintain records of acceptable
suppliers, contractors, and consultants.
22
Purchasing Data
21 CFR 820.50(b)
Each manufacturer shall establish and maintain
data that clearly describe or reference the
specified requirements, including quality
requirements, for purchased or otherwise
received product and services.
23
Purchasing Data
21 CFR 820.50(b) Cont.
Purchasing documents shall include, where
possible, an agreement that the suppliers,
contractors, and consultants agree to notify
the manufacturer of changes in the product or
service so that manufacturers may determine
whether the changes may affect the quality of a
finished device. Purchasing data shall be
approved in accordance with § 820.40.
§ 820.40 Document controls.
24
AGREEMENT
Key topics covered by the Suppler Quality Agreement are:
■ Ownership of product specifications
■ Inspection plans
■ Audit functions
■ Complaint handling processes and responsibilities
■ Change control
■ Process validation
■ Process controls
■ Design controls
■ Control of subtier suppliers
■ Legal aspects
■ Key personnel responsibilities and contact information
http://www.mddionline.com/article/fda-focus-managing-supplier-purchasing-controls
25
Change Control
Ensuring that effective change control processes are
fully implemented requires:
■ Clear language within the supplier Quality
Agreement .
■ Effective supplier quality system change control
processes.
■ Consistent provision of change control information to
the manufacturer.
■ Oversight by the supplier’s and manufacturer’s audit
processes.
http://www.mddionline.com/article/fda-focus-managing-supplier-purchasing-controls
26
GHTF Guidance Document
Quality management system – Medical
devices - Guidance on the control of
products and services obtained from
suppliers.
GHTF/SG3/N17:2008
27
Guidance vs. Regulation
• Manufacturers are not required to comply
with guidance documents.
• Guidance is voluntary and is a way of
doing something that FDA generally
recognizes as acceptable.
• Manufacturers are required to comply with
the Quality System Regulation.
28
Notice
May 31, 2010
Our file number: 10-109706-625
Subject: Adoption of Global Harmonization Task Force (GHTF) Guidance: Quality Management
System - Medical Devices - Guidance on the Control of Products and Services Obtained from
Suppliers
Health Canada is pleased to announce the adoption of the GHTF Guidance Quality
Management System - Medical Devices - Guidance on the Control of Products and Services
Obtained from Suppliers.
This guidance has been developed by the appropriate GHTF Expert Study Group (Study Group 3)
and has been subject to consultation by the regulatory parties, in accordance with the GHTF Process.
The GHTF Steering Committee has endorsed the final document.
In adopting this GHTF guidance, Health Canada endorses the principles and practices described
therein. This document should be read in conjunction with this covering letter and with the relevant
sections of other applicable Health Canada guidances.
This and other guidance documents are currently available on the Health Canada website.
REF: http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guideld/md_gd_suppliers_im_ld_fournisseurs-ghtf-eng.php
29
GHTF Guidance Document
Scope
• For the purposes of this document, a product or
service is one which is purchased or otherwise
obtained by the manufacturer.
• In addition, a supplier is anyone that is
independent from the manufacturer’s quality
management system. This includes a supplier that
may be part of the manufacturer’s organization but
operates under a separate quality management
system.
30
Internal Suppliers
• If the supplier is not a part of the manufacturer’s
internal audit (quality audit) scope, then the
supplier is under a separate quality management
system and is considered an internal supplier
• Corporations that have corporate quality policies
and procedures do not necessarily place all
divisions or groups under the same quality
management system
• Internal suppliers are to be controlled under a
similar way as external suppliers are
controlled.
31
Manufacturer’s Responsibility
The “manufacturer” or entity has the ultimate
responsibility for its quality management system,
cannot relinquish (contractually or otherwise) its
obligation and responsibility over any or all
functions within the quality management
system... the responsibility for complying
with the quality management system
requirements cannot be delegated to any
supplier (internal or external) of products and
services.
32
Regulated Suppliers
Some suppliers may undergo some form of
oversight either by a regulatory authority, or
a third- party operating on behalf of a
regulatory authority. This oversight does
not relinquish the responsibility of a
manufacturer to establish controls and
provide evidence for products and
services obtained from suppliers.
33
Phases Of Supplier Controls
The process of establishing controls for products and
services obtained from suppliers typically comprises six
phases, which include:
– 3.1 Planning
– 3.2 Selection of potential suppliers
– 3.3 Supplier evaluation and acceptance
– 3.4 Finalization of controls and responsibilities
– 3.5 Delivery, measurement and monitoring
– 3.6 Feedback and communication, including
Corrective and Preventive Action process
34
FDA Review of Purchasing Controls
• Inspections
– Quality System Inspections Technique (QSIT)
- Production and Process Controls
– Compliance Program (7382.845) – Inspection
of Medical Device Manufacturers
• Premarket Approval Applications(PMAs)
36
Inspection of Medical Device
Manufacturers
COMPLIANCE PROGRAM 7382.845
Selection of manufacturing processes for
inspectional coverage should include the following
considerations:
– CAPA indicators of process problems
– Processes used to manufacture high risk
products
– Processes that have a high risk of causing
product failure
– Processes that require process validation
37
Inspection of Medical Device
Manufacturers
COMPLIANCE PROGRAM 7382.845
Selection of manufacturing processes... Cont.
– Processes that are new to the manufacturer
– Processes that cover a variety of process technologies
and profile classes
– Common processes used in multiple products
– Processes not covered during previous inspections
– It is important to thoroughly cover Purchasing
Controls, to include outsourced processes, as a QSIT
linkage under P&PC
38
Quality System Regulation
Sub-Part
Title
Sub-Part
Title
A
General Provisions
I
Non-Conforming Product
B
Quality System
Requirements
J
Corrective & Preventive
Action
C
Design Controls
K
Labeling & Packaging
Controls
D
Document Controls
L
Handling, Storage,
Distribution, Installation
E
Purchasing Controls
M
Records
F
Identification & Traceability
N
Servicing
G
Production & Process
Controls
O
Statistical Techniques
H
Acceptance
Activities
39
PURCHASING CONTROLS
Quality System Linkages
–
–
–
–
Design Controls
Risk Management
Acceptance Activities
Production & Process Controls
• Change Control
• Validation
– CAPA (Nonconforming Product, Complaints)
– Management Controls: Auditing, Quality Planning,
Quality Policy
– Document control and records
40
PURCHASING CONTROLS
Quality System Linkages
FDA-483 Quality Policy
“Although the company's quality policy states
that its intent is "to provide the medical
profession with quality products that meet all
regulatory requirements," management did not
notify customers of potentially non-conforming
products that remained on the market.”
41
Examples 2012 Warning
Letters With Purchasing
Controls Citations
42
Warning Letter 37-12
• Failure to establish and maintain procedures to ensure that all purchased
or otherwise received product and services conform to specified
requirements, as required by 21 CFR 820.50. For example, your firm
does not have a quality agreement between (b)(4)(supplier of
Synatron 2000 components) and your firm. Also, there was no
documentation that any evaluations or qualifications of suppliers of
components used for the Synatron 2000 have been performed.
• Failure to establish and maintain procedures for acceptance of incoming
product, as required by 21 CFR 820.80(b). For example, your firm does
not have procedures for inspections, tests, or other verification
activities to control receiving of components used for the Synatron
2000.
43
Warning Letter SEA 12-31
Failure to adequately establish and maintain procedures for finished device
acceptance to ensure that each production run, lot, or batch of finished
devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, your firm’s procedure, Generation, Review and Approval of
Quality Agreements (SOP-0019, Rev. A) states that a fully approved
Quality Agreement shall be in place prior to release of product for
distribution. However, your firm’s Quality Agreement (QA-0001, Rev. B)
with its sleeve supplier, (b)(4), effective from August 10, 2009, to December
13, 2011, did not cover the manufacturing of the GMD 1011 and GMD 1012
sling. Your firm began to distribute GMD 1011 sling in May 2010 and
GMD 1012 sling in June 2010. However, a Quality Agreement for the
manufacturing of GMD 1011 and GMD 1012 slings was not established
until December 13, 2011.
44
Warning Letter SEA 12-31
Failure to adequately establish and maintain procedures for acceptance of
incoming product; inspect, test, or otherwise verify as conforming to specified
requirements; and document acceptance or rejection, as required by 21 CFR
820.80(b). For example, your firm determined that the (b)(4) process was
the root cause of the sleeve breakage/malfunction complaints. Nine lots
… were manufactured using the(b)(4) method. The acceptance activities
receipt provided by your firm’s sleeve supplier, (b)(4), did not include
test results demonstrating that the products from the identified lots met
their specified requirements. Your firm also did not perform any testing
of the finished device received from (b)(4) to determine if the products
met their specified requirements. However, these lots were released for
distribution.
We reviewed your firm’s response and conclude that it is not adequate. ...The
response did not address what methods are in place, other than the
Certification of Compliance, to demonstrate that products received by
(b)(4) are conformed to their specified requirements.
45
Warning Letter SEA 12-31
Failure to adequately investigate the cause of nonconformities related to product,
processes and the quality system, as required by 21 CFR 820.100(a)(2). For
example, your firm’s sleeve supplier, (b)(4), never notified your firm per its
Quality Agreement (QA-0001, Rev. B), that its contract manufacturer, (b)(4),
has changed a manufacturing process, which involved switching from (b)(4)
method to (b)(4) method. Your firm was notified about this change by (b)(4) on
December 15, 2010, approximately seven months after the implementation of
the change. (b)(4) additionally informed your firm that the (b)(4) method
improved the tensile strength of the sleeve. After the implementation of this
manufacturing change/fix, your firm received 20 complaints (6 of which were
MDRs) for the ...sling ... and 16 complaints (7 of which were MDRs) for the GMD
1011 sling ... However, your firm failed to identify and report the previous
manufacturing process ((b)(4) method) as a potential cause of sleeve
breakage issues to the CAPA leader per its Standard Operative Procedure,
Corrective and Preventive Action Management (SOP 0060 Rev. E).
46
Warning Letter NYK-2012-24
Failure to establish and maintain procedures to ensure that all
purchased or otherwise received product and services conform to
specified requirements, as required by 21 CFR 820.50. For
example, your firm does not have an agreement with its
supplier, (b)(4), which defines responsibility for device
attributes and quality requirements. Specifications for the
device are not defined between (b)(4) and... Further, although
(b)(4) is listed on your firm’s Approved Supplier List, IHR-603,
Revision 4, as a critical supplier, your firm failed to follow its
own procedure in requiring critical suppliers to have a Change
Notification Contract. Your firm’s procedure, QAP-601, Rev. 18,
Supplier Assessment, requires a file for each supplier that includes
product specifications and supplier assessments; however, upon
request, no supplier file for (b)(4) was provided to the
investigator.
47
A cross-functional Group / Quality Review
Board is essential for assuring the effective
establishment and maintenance of the
purchasing control subsystem.
48
SUPPLY CHAIN
Impact of Purchasing Controls
Requirements
49
QUESTIONS
Teresa Jiménez
Regulatory Expert Consultants, Inc.
E-mail:
[email protected]
Cell phone: 787 550-1226
50

similar documents