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Journal of GXP Compliance, Vol.13 No. 1 (Winter 2009), Pp. 79-89

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Journal of GXP Compliance, Vol.13 No. 1 (Winter 2009), Pp. 79-89 Page 79 “Framework for Continuous Improvement,” Journal of GXP Compliance, Vol.13 No. 1 (Winter 2009), pp. 79-89. Gordon Welty This article considers occasions that lead to the • Regulatory investigators continuous improvement of GMP processes and the • Health care providers revision of SOPs. Five groups of stakeholders in the • Patients and other health care consumers. sphere of FDA-regulated industry are identified: operational employees, quality unit auditors, regulatory investigators, health care providers, and In brief, operational staff manufacture the patients. The kinds of observations that tend to be regulated product, be it a drug, medical device, associated with each of these stakeholders are: nutritional supplement, etc. The quality auditors escalated events tend to be associated with employees; function independently to monitor the activities internal audits with auditors; 483 observations with of operational staff as well as the quality regulatory investigators; adverse events with health attributes—the safety, identity, strength, purity, care providers; and customer quality complaints with and quality (SISPQ) of the product. Agency patients. These observations initiate an investigation investigators in turn regulate the activities of and revising process that varies in emphasis but that both operational and quality staffs. Healthcare has an underlying logic. An observation is typically providers prescribe the product, and patients escalated, triaged, and can become the basis of an investigation and root cause analysis. At the utilize the product. conclusion of the investigation, remediation can be proposed in the form of CAPA, and may ultimately Any member of these groups can make an lead to the revision of an SOP. A diligent approach to observation that may bring about an revision promotes the continuous improvement of the investigation and root cause analysis. The GMP process. outcome of an investigation can be followed by the development and execution of corrective INTRODUCTION actions and preventive actions (CAPA). The This article discusses the events and situations logic of this investigative and revising process that, when observed and acted upon, initiate the may be more or less explicit in the various revision of processes and procedures covered by regulated industries, but the underlying logic is good manufacturing practices (GMPs) in a the same. regulatory industry such as that covered by the US Food and Drug Administration or other A CAPA can identify several kinds of global regulatory agencies (1). Systematic remediation for a given observation (e.g., pursuit of revision leads to continuous business process redesign, risk mitigation, improvements. Events and situations do not organizational development programs, leadership generate the intervention by themselves. The key development initiatives, training intervention, terms here are “when observed and acted upon,” etc.). Some remediation implicates the revision focusing attention on the major groups of of a standard operation procedure (SOP); other stakeholders that can initiate the process leading remediation does not. This article focuses on the to the revision. The persons occupying each of range of intervention and remediation, giving these stakeholder roles must first see, then act, to special attention to those that lead to the revision occasion the intervention. of procedures. There are five major groups of these Following an introductory section that addresses stakeholders. These five groups provide a map of the function of SOPs and the revision of lifecycle the overall sphere of regulated industry. Each documents, the second section discusses the represents a different facet of regulated industry, routine review of procedures. This set of routine including the following: practices can be taken as a baseline for the • Operational staff and their supervisors exceptional practices that are addressed in • Quality unit auditors Page 80 the remainder of this article. The third section Without an SOP the task performance will be addresses the two kinds of internal observations that poorly resourced—either under-resourced or can initiate an intervention and thereby the revision wastefully resourced. In either case, task of SOPs: employee notification to supervision and performance is more costly, since the under- quality (internal) audits. The fourth section discusses resourced case may require rework, and the over- the three types of external observations that may resourced case may require cost recovery. The initiate an intervention and thereby the revision of a sequencing of tasks may go awry without an SOP: regulatory inspections, adverse event reporting, SOP—a task that must precede a task may be and customer quality complaints. omitted, or a task that depends upon another task may be performed too soon. Either of these could PROCEDURES AND CHANGE threaten the integrity of the entire process. Controlled documents such as SOPs, batch records, manufacturing orders, packaging orders, etc. provide In the absence of an SOP, personnel may be guidance for performing tasks. For brevity’ sake, all confused about who is responsible for each task. these controlled documents are referred to herein as Tasks may not be successfully performed if there is “procedures” or “SOPs.” The procedure identifies the no one responsible for it, or if two or more tasks, the environmental and organizational setting employees are responsible for it. Without an SOP for task performance, the resources that make up the there are no standards to define the satisfactory prerequisites to each task, the sequencing of the tasks task completion. within a given process, the personnel responsible for completing the tasks, and the standards that define Business process and regulatory requirements for the satisfactory completion of the tasks. As David using SOPs incorporate the necessity of revising Peterson states, “The purpose of an SOP is procedures. The revision process provides an straightforward: to ensure that essential job tasks are opening for continuous improvement insofar as the performed correctly, consistently, and in changes represent improvement. FDA’s predicate conformance with internally approved procedures. rules call for not only “written procedures” that Clearly, employees’ correct, consistent performance “shall be followed,” but the predicate rules also of essential job tasks is as much a business and stipulate “written procedures, including any quality issue as it is a regulatory requirement (2).” changes” (5). There are several aspects to this issue The use of economic good sense. of “changes.” First, an SOP is a controlled document, so any change in the associated process Of course, the use of SOPs is also a regulatory must be documented in conformity with the requirement. FDA has stipulated, “There shall be organization’s change control process. Second, the written procedures for production and process control FDA predicate rules stipulate that the GMPs must designed to assure that the drug products have the be “current,” (i.e., CGMPs), so that changes in the SISPQ they purport or are represented to possess.” associated process or practices must be captured in Furthermore, “such written procedures shall be the procedure in a timely fashion. Third, followed”(3). FDA has stated similar predicate rules technological change is ubiquitous in life science for written SOPs for many of the areas under its industry, so there will always be the necessity of jurisdiction, as displayed in Table I. FDA has even revising SOPs as an aspect of business process as stipulated predicate rules for written SOPs that apply well as a regulatory requirement. to itself, Good Guidance Practices (4). Because SOPs must be and are constantly revised, Without SOPs, there is confusion about what the it will prove useful to identify the various kinds of task is and where the task should be performed. events Table I: FDA predicate rules for written SOPs. Regulated Area Regulation Predicate Rule Biologics 21 CFR 600.80 Post market AEs Food 21 CFR 179.25 Food irradiation GCP 21 CFR 56.101 IRBs GCP 21 CFR 310.305; §314.80 Post market AEs GLP 21 CFR 58.35 QA unit GMP 21 CFR 211.186 Control records GTP 21 CFR 1270.31; §1271.180 Good tissue practices HAACP 21 CFR 120.11 Calibration Medical Devices 21 CFR 812.25 Investigational plan Page 81 and situations that may call for the revision of lifecycle documents. It makes the point that change procedures. Neither an event nor a situation opens the way for continuous improvement of the automatically calls for intervention; these must be GMP process. The next section addresses the routine labeled as “events or situations of interest” by an review of lifecycle documents. appropriate administrative procedure. There are two fundamental kinds of occasions for revision: routine ROUTINE REVIEW OF LIFECYCLE review of life-cycle documents and revision due to DOCUMENTS observations of a non-conformance, etc. In turn, there The routine review of lifecycle documents takes are five main kinds of observations—those that place on a regular schedule, typically every two years follow from escalated events, from internal audits, (biennial review) or every three years (triennial from regulatory (FDA) inspections, from adverse review) (7). At the beginning of the lifecycle, the events (AEs), and from customer quality complaints. specific version of the SOP is approved by These five kinds of observations correspond to the management and quality assurance and is then
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