Applying Statistical Process Control Pharmaceutical Manufacturing the Essay

Download this Essay in word format (.doc)

Note: Sample below may appear distorted but all corresponding word document files contain proper formatting

Excerpt from Essay:

Applying Statistical Process Control Pharmaceutical Manufacturing

The use of applied statistics in studying a pharmaceutical manufacturing process is examined in the work of Tiani (2004) reports that health care quality is critically important in society and the quality of health care is important to all individuals. It is important that treatment is given in an accurate manner and this is particularly true of medications given to patients as it is expected that "the bottle of medicine has the specified number of tablets and that each tablet contains the specified quantity of the correct drug." (Tiani, 2004)

Legal and Regulatory Framework

There are legal and regulatory requirements set out in the law of the United States that the quality of medications be controlled in the pharmaceutical industry. The regulations are contained in federal statutes and outline "a quality control functions that emphasizes inspection and defect detection, and pharmaceutical quality control technology." (Tiani, 2004) It is reported that the drug product "features are the easiest to understand, measure, and control" is that falling under the classification of the medication chemical or physical attributes." (Tiani, 2004) According to Tiani (2004) the United States Pharmacopoeia (USP) is inclusive of "standards for drugs and pharmaceutical substances" referred to as Official Monographs. The USP standards are "official and required by law in the U.S. under the 'Food, Drug, and Cosmetic Act'. " (2004)

Process Analytical Technology (PAT)

Process Analytical Technology has been developed to provide support for the development of pharmaceutical manufacturing and quality assurance. There are two reported components to the PAT framework:

(1) A set of scientific principles and tools supporting innovation; and (2) A strategy for regulatory implementation that will accommodate innovation. (Janardhan, 2011, 2011)

Quality problems in the petrochemical industries "need to be corrected before they contaminate large volume of products." (Janardhan, 2011 ) Pharmaceutical companies are reported to suffer from "excessive rework and scrap, high work-in-process, low capacity utilization, prolonged cycle times and laboratory bottlenecks." (Janardhan, 2011) The AMR reports that the "industry average for both rework and discarded product is about 50%" and that on-hold product inventories "are at the 40 to 60 day level." (Janardhan, 2011) Plant utilization is reported as being "in the range of40 to 50%" and average cycle times stated in the 30 to 90 day range." (Janardhan, 2011)

PAT Solutions

Some of the PAT solutions for research development, scale-up and manufacturing of drug substances are the following areas: (1) identification of raw material; (2) monitoring of online manufacturing processes; and (3) online analysis. (Janardhan, 2011) Key modules of the PAT solution include: (1) acquisition of data; (2) storage of data; (3) mining, visualization and multivariate analysis of data; and (4) control. (Janardhan, 2011) Process parameters reported as used include: (1) Infrared (IR); (2) ultraviolet-visible spectrophotometry (UV-VIS), (3) Raman, (4) High Performance Liquid Chromatography (HPLC) and (5) Mass Spectroscopy. (Janardhan, 2011) The following chart shows the worldwide use of PAT instrumentation and software.

Figure 1

Worldwide Use of PAT Instrumentation and Software

Source: Janardhan, 2011

A survey is reported in the work of Shanley (2011) and stated specifically is that pharmaceutical manufacturers reported the use of process capability analysis and statistical process control" as well as the trends as follows: (1) interest in continuous processing has increased: (2) there is better alignment between IT and process control operations and operational excellence goals; (3) there is slowed installation of new technology platforms due to plant closures and off shoring of operations; and (4) there is an increased use of wireless monitoring and greater interest in process applications. (Shanley, 2011)When participants in the survey were asked if continual improvement and operational excellent programs such as six sigma served to guide automation and IT goals the following responses were given:

Question 2010-2009

Progress being made 30% 38%

Yes, more or less 26% 15%

Not really 18% 22%

Top priority 16% 19%

Not at all 9% 6% (Shanley, 2011)

When participants in the survey were polled on PAT and the broader Quality by Design (QbD) approach and whether either or both approach was being implemented by their company responses given include the following:

Not planning on either 32%

Focus on QbD with PAT 21%

Starting PAT, not QbD 17%

Doing PAT, but planning QbD 13%

PAT establishment, starting QbD 11% (Shanley, 2011)

Reasons stated that QbD would not be implemented include the following stated reasons:

Cost 44%

Lack of qualified staff 39%

Inability to justify based on benefits 32%

Lack of understanding 25%

Lack of support from upper management 23% (Shanley, 2011)

There is stated to be an increase in the interest in wireless monitoring in the pharmaceutical industry as 38% of participants state that their company is not using wireless monitoring yet, but has plans for use of wireless monitoring in the warehouse and processing. (Shanley, 2011) According to the U.S. Department of Health and Human Services Food and Drug Administration in the work entitled "Guidance for Industry Process Validation: General Principles and Practices" the written protocol specifying the manufacturing conditions, controls, testing and expect outcomes should include the following elements: (1) The manufacturing conditions, including operating parameters, processing limits, and component (raw material) inputs; (2) The data to be collected and when and how it will be evaluated; (3) Tests to be performed (in-process, release, characterization) and acceptance criteria for each significant processing step; (4) The sampling plan, including sampling points, number of samples, and the frequency of sampling for each unit operation and attribute. The number of samples should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. The confidence level selected can be based on risk analysis as it relates to the particular attribute under examination. Sampling during this stage should be more extensive than is typical during routine production. (U.S. Department of Health and Human Services Food and Drug Administration, 2011)

Statistical Process Control

Statistical process control is reported as being used to "make a process stable over time" and keeping the process stable unless changes to plans are made." (U.S. Department of Health and Human Services Food and Drug Administration, 2011) Changes in stability over time require that that "pattern of variation remain stable, not that there be no variation in the variable measured." (U.S. Department of Health and Human Services Food and Drug Administration, 2011) Statistical quality control involves a process that has one control and has only common cause variation, which is the "inherent variability of the system, due to many small causes that are always present." (U.S. Department of Health and Human Services Food and Drug Administration, 2011) When the process is disturbed by an event that is not predictable, 'special cause 'variation is added to the common cause variation." (U.S. Department of Health and Human Services Food and Drug Administration, 2011)

Control charts are reported to work through "distinguishing the always-present common cause variation in a process form the additional variation that suggests that the process has been disturbed by a special cause. A control chart sounds an alarm when it sees too much variation." (U.S. Department of Health and Human Services Food and Drug Administration, 2011) It is necessary to estimate the process mean and standard deviation from previous data on the process and under these monitoring conditions there are many observations and control in the process has been maintained. Formulation of control charts begins by taking samples spaces at regular intervals and because the observations in the sample will be so close to one another making it possible to assume that the process, during the brief period of monitoring has remained stable. Variation identified with in the same sample provides a benchmark for the common cause variation in the process and the process standard deviation speaks of the standard deviation within the specified timeframe spanning one sample. When control in the…[continue]

Cite This Essay:

"Applying Statistical Process Control Pharmaceutical Manufacturing The" (2011, December 27) Retrieved October 22, 2016, from

"Applying Statistical Process Control Pharmaceutical Manufacturing The" 27 December 2011. Web.22 October. 2016. <>

"Applying Statistical Process Control Pharmaceutical Manufacturing The", 27 December 2011, Accessed.22 October. 2016,

Other Documents Pertaining To This Topic

  • Market Driven Management

    Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while competing with other companies that manufacture products that treat similar afflictions and ailments. The complexities in drug research and development and regulations have created an industry that is subject to intense

  • New Drug Development and Approval

    Initial product formulation utilizes knowledge acquired from pre-formulation outcomes to derive proper dose, dosage form, and type of administration for the proposed marketed use. A pilot batch of Clinical Trial Materials (CTM) may be produced after the new drug has completed these initial tests. Upon completion of preclinical testing, the drug sponsor files an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), after they have

  • Japanese American Biopharmaceutical Industry in the 21st Century

    Japanese-American Biopharmaceutical Industry in the 21st Century Optimizing Ethical Drug Availability Between These Two Pharmaceutical Superpowers" The Japanese-American biopharmaceutical industry represents an ongoing international effort between the two top pharmaceutical markets in the world. These two economic powers provide consumers with a majority share of all pharmaceuticals produced in the world. However, a number of pharmaceutical products that are currently available to U.S. residents are unavailable to Japanese consumers. From a humanitarian perspective, this

  • Promising Phenomenon That Lends Itself

    66). Furthermore, social software will only increase in importance in helping organizations maintain and manage their domains of knowledge and information. When networks are enabled and flourish, their value to all users and to the organization increases as well. That increase in value is typically nonlinear, where some additions yield more than proportionate values to the organization (McCluskey and Korobow, 2009). Some of the key characteristics of social software applications

  • Vehicle Recall on Consumer Perception

    They may be forced to follow the technical procedures that are related to the recall that may seem time consuming on their part. In cases where the defect has caused the life of someone then monetary compensation may not suffice as life is deemed precious than the monetary compensation that may be awarded. Recall usually causes a lot of disruption to consumers hence creating a major confusion to the personnel

  • Air Traffic Has Continued to Increase and

    air traffic has continued to increase and it now constitutes a considerable proportion of the travelling public. The amount of long-hour flights has increased significantly. Based on the International Civil Aviation authority, air traffic can be anticipated to double amid till 2020. Airline travel, especially over longer distances, makes air travelers vulnerable to numerous facets that will impact their health and well-being. Particularly, the speed with which influenza spreads

  • Abnormal Psych in Media Disorganized

    This confusion would have been intolerable for him, creating disorganized patterns of thought. Out of this disorganization developed delusion. The boy came to imagine that the father killed the mother. Another way cognitive (and psychodynamic) approaches explain the genesis of schizophrenia is by reference to childhood trauma. Things such as abuse, divorce, a domineering mother, or witnessing murder are seen as major factors in schizophrenic development (Koehler & Silver, 2009,

Read Full Essay
Copyright 2016 . All Rights Reserved