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Maintaining a Validated State – PV, PM and Statistics associated with Current Regulation
Description :
Statistical Applications – Use of a statistician or person with adequate statistical training (not just 6 Sigma) to develop the experimental design and the statistical methods / models needed to measure and evaluate process capability, uniformity and on-going stability.

Generate A Sense of Control – Process design and development, when assessed by the statistician, should anticipate significant sources of variability and establish statistically significant means of detection, control and mitigation strategies as well as initially finding a means of defining the alert limits and action limits that will most likely change as the process moves into a routine operation and now provides SQC and 6 Sigma opportunities. Too often, as sited in a variety of 483s, 6 Sigma was used to establish limits during development which is a significant statistical error.
Why ?
Process knowledge and understanding is the basis for establishing and approach to process control for each unit of operation specific to equipment variables in order to generate overall process control needed for validation. The current majority of serious warning letters and consent decrees have been issued against companies with years of experience but an overall miscomprehension of the validation expectations. Is a validated process that has a significant number of OOS batches considered a validated process? A system or systems for detecting unplanned departures from the process as initially designed or currently operated is essential to accomplish this objective.

Educating the Experienced
How do we teach old dogs new tricks?
How do we teach new dogs new tricks?
We have to know what the objective is, what tools we have in our tool-box, know how to use them and demonstrate the confidence to apply them.
How to get more bang for your buck (validation is a cost savings program, but validation is viewed by executives as serious expense that would like to be avoided)
Randomized Block Statistical Model for Effective Validation
Grouping to have the units in a block as uniform as possible so that observed differences will be largely do to treatment and make root cause analysis simple and accurate.
Measure uniformity within a loaded sterilizer chamber and at the same time map the chamber….in two runs we can tell as much about the performance of the sterilizer using a randomized block experimental design as is normally with a dozen or so experimental temperature distribution and heat penetration runs.
Uses randomization, an expectation of uniformity, analysis of variance and an equally likely chance for each location to have an independent lethality value of all other locations in the chamber.
Areas Covered in the Session :
Continued monitoring and/or sampling at the levels established during the development and qualification stages until sufficient data is available to generate statistically significant variability estimates. Once the variability is known, sampling and/or monitoring should be adjusted to a statistically significant level. Variation is to be used to detect the potential for defect complaints, OOS including OOT and OOL results, including deviation reports, process yield variations, BPR deficiencies, incoming raw material variances, adverse events and many other issues that may be found to enhance a validated (cost effective with minimal patient risk) means of operation. Hence change control becomes a critical component using SSR (sound scientific rationale) to manage an on-going validated state.
  • Appropriate Application of Simple Statistical Tools, the Scientific Methods, facts, theories, proposals, functional requirements (FRS), acceptance criteria, formation of a hypothesis that is logical with sound scientific rationale by being scientifically based making it defendable.
  • Objective Evaluation - To most scientists, statistics is logic or common sense with a strong admixture of arithmetic procedures. The logic supplies the method by which data are to be collected and determined how extensive they are to be. Critical thinking as opposed to assumed awareness creates significant issues during the evaluation phase of any process.
  • The arithmetic, together with certain numeric tables, yields the material on which to base the inference and measure the level of uncertainty associated with the process variables.The arithmetic is often routine, requiring no special mathematical training for the user, however the choice of the statistical model requires significant comprehension of the process in order to select the appropriate statistical model, then make sure the sampling fits the model so the arithmetic can be done to determine how the ANOVA results can be interpreted to demonstrate a maintained validated state.
  • Process observations and data retrieval are the raw materials with which quality and statistical workers deal which means the results need to be in the form of numbers (objective evidence) as result of a measurement, not subjective results from check boxes. Tracking the pass/fail results is only an “appetizer” to the next phase of the assessment of the validated process including equipment and operator performance.Numbers are what we us to the constitute and address the situation to determine if the data is a variability or variation.
  • Examples of Objective Data: Yield, pressure, pH, flow rate, time and lapse time, amounts, number of defects, length, duration, and many, many more depending on the validated equipment and associated process.
  • Our Responsibility: We are to manage the collection based on the statistical model. Presentation, characterization and, summarization of data including potential elements such as the results from the regression analysis, z-score, randomized block and a multitude of other means of assessing the consistency and identified variables of the validated process.
  • ANOVA - Analysis of Variance not used to test hypotheses about variances used to test hypotheses about means (bar x and double bar x). Lifetimes of two different types of light bulbs. Effectiveness of two different toothpastes.Now we calculate the sum of squares and variances to measure variation between and within groups. Why? - Because we are trying to test a hypothesis about the equality of the data’s average or data’s mean.Sum of squares – sum of the variance (an individual value minus the average squared). Null Hypothesis – we test to demonstrate that the difference between the means is null (not 0) or insignificant.Linear Regression and Correlation. Used to Predict unknown values within a bracket (minimum and maximum operating rangesqutside a bracket – future (be careful). Line of Best Fit (Regression Line), the slope and the Y intercept define the regression line, the idea behind finding a regression line (line of best fit) is based on the assumption that the data is scattered randomly about a single straight line.Correlation Coefficient – 1 is perfect – either positive or negative – 0 indicates the data have no correlation. Correlation is the term used to indicate how close to the single line the data fall
  • Experimental Design - By now we should begin to understand the need to be able know how we want to analyze the data before we begin to collect individual observations.
Who Will Benefit:
  • Statisticians
  • Quality
  • Engineering and Documentation Personnel within the Pharmaceutical
  • Medical Device
  • Solid Dosage Companies
About Speaker:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US, Central America, Mexico and Europe. He has worked with or assisted way more than dozens of companies with the establishment of controlled document/quality systems, FDA/EPA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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