FDA Makes Quality the Rule (continued) 2525

An MD&DI January 1997 Feature Article

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

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

Among the subparagraphs of the quality system regulation that describemanagement responsibility, the following three deserve further discussionbecause they establish entirely new requirements.

Management Review (820.20(c)). Upper management will be required toperiodically review the suitability and effectiveness of the quality system inaccordance with a written procedure, and to produce a written report. The reportwill not be subject to FDA review (820.180(c)). The management review report isintended to be much broader than an internal quality audit and should beconducted to determine the state of control of the quality system, thesuitability of the company's processes, the adequacy of its resources, and theacceptability of its finished products. Typical information sources that shouldbe reviewed include summaries of complaints, returned products, servicingreports, results of the company's corrective action program, and internal auditresults.

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

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

Quality System Procedures (820.20(e)). This section was also not a partof 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 theirquality system documentation.

This requirement, and the quality planning requirement above, were added inorder 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 EN46001 for the purpose of granting a CE mark look for such an outline whenconducting audits.⁸ However, for the manufacturer not exporting tothe EU this requirement will mean additional--and possiblyextraneous--documentation. In the preamble to the regulation (comment 54), FDAadmits that such an outline may not be necessary for small manufacturers; forthis reason, an outline of the quality system documentation is required only "whereappropriate." The preamble does not specify the level of detail expected insuch an outline.

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

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

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

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

INTRODUCTION

QUALITY SYSTEM REQUIREMENTS

DESIGN CONTROLS

REFERENCES