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I. Contents of quality risk management sop ////////////////// In most most coun countr trie iess compl complia ianc ncee ith ith good good manu manufa fact ctur urin ing g prac practi tice cess 0+ 0+33 (1, (1, 2) 2) 0including valida validatio tion3, n3, drug drug regula regulator tory y activi activiti ties es and inspec inspectio tions, ns, togeth together er ith ith supply supply chain chain control controlss throughout the product life"cycle, provide good assurance that risks are largely controlled. 4oever, here control is less effective, patients may be put at risk through the production of medicines of inadequate quality. 5he assessment of individual risks related to specific products and starting materials and the recognition of ha6ards at specific stages of production or distribution should permit regulatory authorities to improve control of medicines by increasing the effectiveness of their activities ithin the limits of the available resources. Quality risk management 0Q73 is a process that is relevant to all countries and should provide a rationale to understand risk and mitigate it via appropriate and robust controls.
5he aim of this guideline is to assist the development and implementation of effective Q7 coveri covering ng activi activitie tiess such such as resear research ch and develop developmen ment, t, sourci sourcing ng of materi materials als,, manufa manufactur cturing ing,, packaging, testing, storage and distribution. In the past, ha6ard analysis and critical control point 04899+3 methodology, traditionally a food safety management system but subsequently applied to other industries, has been the basis of :4' risk management guidance to the pharmaceutical industry (3). (3).
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&ince &ince then then inte intern rnat atio ional nal guid guidan ance ce has emer emerge ged d (2, (2, 4-8) 4-8) that that is of spec specif ific ic rele relevan vance ce to the the pharmaceutical industry and hich addresses the full scope of pharmaceutical ph armaceutical industry Q7 more effectively than 4899+ principles, including ho to structure regulatory filings using a risk"based approach. 9onsequently, this :4' guideline has been developed as an update of :4' advice to the pharmaceutical industry, taking account of this ne guidance.
In order order to protec protectt patien patients, ts, in terms terms of qualit quality y, safety safety and effica efficacy cy,, intern internati ational onal medici medicines nes regulatory authorities 078s3 are recommending pharmaceutical manufacturers to adopt a risk" based approach to the life"cycle of a pharmaceutical product. &ome 78s are requiring the adoption of a risk"based approach for certain specific areas in the life"cycle of a pharmaceutical product, e.g. for environmental monitoring for sterile products manufacturing. manufacturing.
:hile the choice of the tools to support supp ort the Q7 approach is optional and may vary, they need to be appropriate for the intended use.
In retu return rn for for usin using g this this appr approa oach ch,, ther theree are are pote potent ntia iall oppo opport rtun unit itie iess for for both both 78s 78s and and pharmaceutical manufacturers (9) as summari6ed in the folloing sections.
a3 Qualit Quality y risk risk managem management ent 0Q73 0Q73 princi principle pless can be applied applied to both both 78s 78s and pharmaceu pharmaceutic tical al manufacturers; •
78s; systematic and structured planning of revies and inspections that are risk"based. 5he submission revie and inspection programmes can also operate in a coordinated and synergistic manner.
•
anufacturers; design, development, manufacture and distribution, i.e. the life"cycle of a pharmaceutical product. Q7 should be an integral element of the pharmaceutical quality system 0+Q&3.
b3 &cience"based decision"making can be embedded into Q7 processes; •
78s; decisions decisions regarding regarding revie, revie, inspection inspection or inspection inspection frequency should should consider consider product risk and + compliance of the manufacturer. 5he 78 accepts residual risks
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effect effective ive applica applicatio tion n should should offer offer manufa manufactu cturer rerss greate greaterr freedom freedom on ho to meet principles of +, +, and this, therefore, therefore, should encourage innovation. 5he control strategy for the process focuses on critical quality attributes and critical process parameters.
c3 7esources 7esources can be be focused focused on risks risks to patient patients; s; •
78s; Q7 can be used to determine best allocation of inspection resource, both in terms of product types and for specific areas of focus for a given inspection. 5his enables the most efficient and effective scrutiny of the most significant health risks. 5hose manufacturers ith poor histories of + compliance can also be more closely and frequently evaluated by on"site inspection than those manufacturers ith better records.
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anufacturers; evaluation of quality risk through science"based decisions can be linked ultimately to protection of the patient by ensuring the quality, safety and efficacy of the product. 8 corporate culture is supported to produce cost"effective medicines, ithout compromising quality, hile maintaining focus on the patient as a primary stakeholder in all activities.
d3 7estrictiv 7estrictivee and unnecess unnecessary ary practic practices es can be avoided; avoided; •
•
78s; 78s; regula regulator tory y scruti scrutiny ny adust adusted ed to level level of risk risk to patien patients. ts. Improv Improveme ement nt and innovation by manufacturers should be encouraged.
anufacturers; instead of having systems designed to inhibit change and minimi6e business risk, changes can be managed ithin a company>s quality management system. Innovation and the adoption of the latest scientific advances in manufacturing and technology are supported. supported.
e3 9ommunicati 9ommunication on and and transpa transparency rency are facilitat facilitated; ed; •
•
78s; facilitate dialogue ith pharmaceutical manufacturers and clarify to the industry and the public on ho the inspection programme may be adusted based on the risk to patients. Information"sharing beteen 78s ill contribute to a better risk management approach globally.
anufacture anufacturers; rs; matri
team approach, approach, stakeholders stakeholders kept informed informed via science"bas science"based ed
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Q7 is the overall and continuing process of appropriately managing risks to product quality throughout its life"cycle in in order to optimi6e its benefit!risk balance. It is a systematic systematic process for the assessment, control, communication and revie of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
5his guideline ill align ith the general frameork described ithin other current i nt e r nat i o nal
g ui danc eo nt hi ss ubj e c t .
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III. Quality management tools
1. Check sheet 5he check sheet is a form 0document3 used to collect data in real time at the location here the data is generated. 5he data it captures can be b e quantitative or qualitative. :hen the information is quantitative, the check sheet is sometimes called a tally sheet. 5he defining characteristic of a check sheet is that data are recorded by b y making marks 0AchecksA3 on it. 8 typical check sheet is divided into regions, and marks made in different regions have different significance. Bata a re read by observing the location and number of marks on the sheet. 9heck sheets typically employ a heading that ansers the Cive :s; • •
:ho filled out the check sheet :hat as collected 0hat each check represents, an identifying batch or lot number3
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:hy the data ere collected
2. Control chart
9ontrol charts, also knon as &hehart charts 0after :alter :alter 8. &hehart3 or process"behavior charts, in statistical process control are tools used to determine if a manufacturing or business process is in a state of statistical statistical control. If analysis of the control chart indicates that the process is currently under control 0i.e., is stable, stable, ith variation only coming from sources common to the process3, then no corrections or changes ch anges to process control parameters are needed or desired. In addition, data from the process can be used to predict the future performance of the process. If the chart indicates that the monitored process is not in control, analysis of the chart can help determine the sources of variation, as this ill result in degraded process p rocess performance.D1E 8 process that is stable but operating outside of desired 0specification3 limits 0e.g., scrap rates may be in statistical control but above desired limits3 needs to be improved through a deliberate effort to understand the causes of current performance and fundamentally improve the process. 5he control chart is one of the seven basic tools of quality control.DE 5ypically control charts are used for time"series data, though they can be b e used for data that have logical comparability 0i.e. you ant to compare samples that ere taken all at
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3. Pareto chart
8 +areto chart, named after Filfredo +areto, is a type of chart that contains both bars and a line graph, here individual values are represented in descending order by bars, and the cumulative total is represented by the line. 5he left vertical a=is is the frequency of occurrence, but it can alternatively represent cost or another important unit of measure. 5he right vertical a=is is the cumulative percentage of the total number of occurrences, total cost, or total of the particular unit of measure. Gecause the reasons are in decreasing order, the cumulative function is a concave function. 5o take the e=ample above, in order to loer the amount of late arrivals by H#, it is sufficient to solve the first three issues. 5he purpose of the +areto chart is to highlight the most important among a 0typically large3 set of factors. In quality control, it often represents the most common sources of defects, the highest occurring t ype of defect, or the most frequent reasons for customer complaints, and so on. :ilkinson 02((-3 devised an algorithm for producing statistically based acceptance limits 0similar to confidence intervals3 for each bar in the +areto chart.
). Scatter plot Method
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8 scatter plot, scatterplot, or scattergraph is a type of mathematical diagram using 9artesian coordinates to display values for to variables for a set of da ta. 5he data is displayed as a collection of points, each having the value of one variable determining the position on the hori6ontal a=is and the value of the other variable determining the position on the vertical a=is.D2E 5his kind of plot is also called a scatter chart, scattergram, scatter diagram,DE or scatter graph. 8 scatter plot is used hen a variable e=ists that is under the control of the e=perimenter. If a parameter e=ists that is systematically incremented and!or decremented by the other, it is called the control parameter or independent variable and is customarily plotted along the ho ri6ontal a=is. 5he measured or dependent variable is customarily plotted along the vertical a=is. If no dependent variable e=ists, either type of variable can be plotted on either a=is and a scatter plot ill illustrate only the degree of correlation 0not causation3 beteen to variables. 8 scatter plot can suggest various kinds of correlations beteen variables ith a certain confidence interval. Cor e=ample, eight and height, eight ould be on = a=is and height ould be on the y a=is. 9orrelations may be positive 0rising3, negative 0falling3, 0falling3, or null 0uncorrelated3. If the pattern of dots slopes from loer left to upper right,
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other. In this case, an identity line, i.e., a y/= line, or an 1;1 line, is often dran as a reference. 5he more the to data sets agree, the more the scatters tend to concentrate in the vicinity of the identity lineL if the to da ta sets are numerically identical, the scatters fall on the identity line e=actly.
5.Ishikawa diagram
Ishikaa diagrams 0also called fishbone diagrams, herringbone diagrams, cause"and"effect diagrams, or Cishikaa3 are causal diagrams created by *aoru Ishikaa 01%-#3 that sho the causes of a specific event. D1ED2E 9ommon uses of the Ishikaa diagram are product design and quality defect prevention, to identify potential factors causing an overall effect. Mach cause or reason for imperfection is a source of variation. 9auses are usually grouped into maor categories to identify these sources of variation. 5he categories typically include • •
+eople; 8nyone involved ith the process ethods; 4o the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and las
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achines; 8ny equipment, computers, tools, etc. required to accomplish the ob
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8 histogram is a graphical representation of the distribution of data. It is an estimate of the probability distribution of a continuous variable 0quantitative variable3 and as first introduced by *arl +earson.D1E +ea rson.D1E 5o construct a histogram, the first step is to AbinA the range of values "" that is, divide the entire range of values into a series of small intervals "" and then count ho man y values fall into each interval. 8 rectangle is dran ith height proportional to the count and idth equal to the bin si6e, so that rectangles abut each other. 8 histogram histogram may also be normali6ed displaying relative frequencies. It then shos the proportion of cases that fall into each of several categories, ith the sum of the heights equa ling 1. 5he bins are usually specified as consecutive, non"overlapping intervals of a variable. 5he bins 0intervals3 must be adacent, and usually equal si6e.D2E 5he rectangles of a histogram are dran so that they touch each other to indicate that the original variable is continuous.DE
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