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FDA Makes Quality the Rule (continued)

An MD&DI January 1997 Feature Article

Key elements of the type of quality system that FDA will expect manufacturers to
establish are spelled out in the new regulation's section on quality system
requirements (subpart B). The section incorporates requirements for management,
for quality auditing, and for personnel training.

Management Responsibility (820.20). Although the 1978 GMP regulation
contained some elements of this section, the new regulation's requirements
concerning management participation in the quality system are much more
specific. Management with executive responsibility must:

  • Establish the company's policy and objectives for the quality system.
  • Demonstrate a commitment to following the quality policy and achieving
    its objectives.
  • Ensure that the company's quality policy is understood, implemented,
    and maintained at all organizational levels.
  • Appoint a member of management who will be responsible for the
    effectiveness of the quality system and report periodically to upper management
    concerning the system's performance.
  • Review the suitability and effectiveness of the quality system at
    defined intervals.

Among the subparagraphs of the quality system regulation that describe
management responsibility, the following three deserve further discussion
because they establish entirely new requirements.

Management Review (820.20(c)). Upper management will be required to
periodically review the suitability and effectiveness of the quality system in
accordance with a written procedure, and to produce a written report. The report
will not be subject to FDA review (820.180(c)). The management review report is
intended to be much broader than an internal quality audit and should be
conducted to determine the state of control of the quality system, the
suitability of the company's processes, the adequacy of its resources, and the
acceptability of its finished products. Typical information sources that should
be reviewed include summaries of complaints, returned products, servicing
reports, results of the company's corrective action program, and internal audit

Quality Planning (820.20(d)). The quality planning requirements
contained in the new regulation were not a part of the 1978 GMP regulation. They
were first proposed as part of the 1995 working draft (820.186(a)), where they
appeared in much more general terms than they do now. The preamble to the 1995
working draft indicated that the intent of this section was to require
manufacturers to develop a quality plan.

As formulated in the new regulation, the requirements for quality planning are
intended to apply to activities that are conducted during the production phase
of a product's life cycle, and should refer to the company's design and
development plan. In practice, the content of a company's quality plan will most
often be provided by the outline of quality system documentation (820.20(e)) and
by the device master record, and the plan itself may refer to sections of those
documents where key activities are detailed. Guidance for establishing a quality
plan can be found in ISO 9004-5.7

Quality System Procedures (820.20(e)). This section was also not a part
of the 1978 GMP regulation, but was contained in the 1995 working draft
(820.186(b) and 820.186(c)). To comply with the requirements of this section,
manufacturers must create a document that outlines the structure of their
quality system documentation.

This requirement, and the quality planning requirement above, were added in
order to harmonize the quality system regulation with ISO 9001 and ISO 9002
(clause 4.2).

Representatives of notified bodies that assess compliance with ISO 9001 and EN
46001 for the purpose of granting a CE mark look for such an outline when
conducting audits.8 However, for the manufacturer not exporting to
the EU this requirement will mean additional--and possibly
extraneous--documentation. In the preamble to the regulation (comment 54), FDA
admits that such an outline may not be necessary for small manufacturers; for
this reason, an outline of the quality system documentation is required only "where
appropriate." The preamble does not specify the level of detail expected in
such an outline.

Quality Audit (820.22). The new regulation's quality audit requirements
are basically the same as those contained in the 1978 GMP regulation. However,
the earlier regulation required manufacturers simply to verify compliance with
the quality assurance program, whereas the new one adds that the audit must also
be used to determine the effectiveness of the quality system. The new regulation
also specifies that the dates of reaudits and reaudit results must be
documented--a requirement that was assumed but not specified in the 1978

In the quality system regulation, FDA has dropped the last part of the
definition of the term audit that was contained in the 1978 GMP
regulation (820.3(b)). That portion of the definition specified that complaint
investigations, failure analyses, and other routine quality assurance activities
were not to be considered part of the quality audit. The purpose of this
statement was to notify manufacturers that these activities would not be exempt
from FDA review. Although the agency has deleted this caution from the section
on definitions, it has restated its position in the preamble under the section
on records (comment 182).

Internal quality audit reports are still exempt from FDA review, but in the
preamble to the new regulation the agency has complicated this long-standing
policy by stating that this exemption does not extend to any corrective actions
taken as a result of such audits (comment 160). In other words, FDA may review
the documentation relating to any corrective actions that result from internal
audits, as well as the documents on corrective actions that may result from
management reviews or supplier audits.

Personnel (820.25). The personnel training requirements of the new
regulation are basically the same as those contained in the 1978 GMP regulation.
The requirement to conduct GMP training that was proposed in the 1995 working
draft has been deleted, but FDA notes in the preamble that employee training
activities should include general information about GMP requirements as well as
about how employees' job functions relate to the company's quality system.
Manufacturers should note that the training requirements apply to "all
personnel"--including top management.





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