Analytical Chemistry in a GMP Environment: A Practical Guide / Edition 1

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How to hone your analytical skills and obtain high-quality data in the era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP compliance issues
* A review of the role of statistics and basic topics in analytical chemistry
* An emphasis on high-performance liquid chromatographic (HPLC) methods
* Chapters on detectors and quantitative analysis as well as data systems
* Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and procedural information

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Editorial Reviews

From the Publisher
"...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly." (SciTech Book News, Vol. 24, No. 4, December 2000)

"Anyone...involved in training exercises and in...gathering...pertinent material from different sources will find this book very helpful." (Journal of Medicinal Chemistry, Vol. 44, No. 21, 2001)

"I recommend this book for anyone who recognizes a need for more and better training of pharmaceut9ical laboratory analysts...a remarkably rich resource." (Clinical Chemistry, Vol. 48, No. 3, 2002)

"...provides a much needed perspective on the role of analytical chemistry in the pharmaceutical industry and is a welcome addition...a useful resource." (Journal of Chemical Education, December 2002)

SciTech Book News
...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly.
SciTech Book News
...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly.
Based on the Laboratory Analyst Training and Certification Program, a two-week course developed and implemented by the Johnson and Johnson company, chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly. The material is at a level suitable for readers who hold bachelors degrees in chemistry and already have some experience in the pharmaceutical laboratory. Among the topics are the drug development process, uniform and consistent interpretation of compliance issues, the role of statistics and basic topics in analytical chemistry, and detectors and quantitative analysis. The emphasis is on high-performance liquid chromatographic methods. Annotation c. Book News, Inc., Portland, OR (
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Product Details

  • ISBN-13: 9780471314318
  • Publisher: Wiley
  • Publication date: 5/1/2000
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 512
  • Sales rank: 1,282,223
  • Product dimensions: 6.44 (w) x 9.27 (h) x 1.18 (d)

Meet the Author

JAMES M. MILLER, PhD, is Emeritus Professor of Chemistry, Department of Chemistry, Drew University, Madison, New Jersey.
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.

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Table of Contents

The Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.).

Laboratory Controls and Compliance (H. Avallone).

The USP, ICH, and Other Compendial Methods (J. Feldman).

Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).

Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).

Spectroscopy (P. Abauf & A. Melveger).

Chromatographic Principles (J. Miller).

Gas Chromatography (J. Miller & H. McNair).

Liquid Chromatography: Basic Overview (L. Polite).

HPLC Column Parameters (R. Hartwick).

Dissolution (R. Kirchhoefer & R. Peeters).

Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).

Some Principles of Quantitative Analysis (J. Miller).

Laboratory Data Systems (R. McDowall).

Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).



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In his Foreword and elsewhere,* Layloff has described the need for more and better training of pharmaceutical laboratory analysts, as perceived by the Food and Drug Administration FDA. To meet their own needs, the FDA produced a series of self-training aids that could be used in their testing laboratories. Many others are equally aware of the need for training because of the constant introduction of new methods, the increasing demands for better analyses, and the fact that little or no discussion of government regulations is presented in the traditional undergraduate educational program of chemists. Johnson & Johnson recognized this need in the spring of 1996 and began the development of an in-house training course. With the help of academic and industrial consultants, the course was first offered in October 1996 and became the basis for this text.

From the onset, the Johnson & Johnson Laboratory Analyst Training and Certification Program's LATCP objective has been to provide lecture and laboratory work in analytical chemical methods and in government regulations CGMPs and procedures. The two-week-long course has been presented over 20 times to over 300 analysts, selected from J&J sites around the world. A special facility was constructed for this purpose at the IRI Trials Management Center in New Jersey; more details on the program can be found in a recent trade publication.y

This book is a natural outgrowth of the LATCP and is being published to make the contents of the program available more widely. The level of the material is that which has been found suitable for the participants in the course, who, on average, hold bachelor's degrees in chemistry and already have some experience in the pharmaceutical laboratory; these are typical recruitment criteria for J&J analysts.

The introductory chapter provides an orientation to the drug development process that might not be familiar to new employees in the pharmaceutical industry. Two chapters follow on regulations and compendia. Together these chapters should serve as a basis for understanding the issues in this regulated industry.

The middle chapters cover some basics of analytical chemistry of relevance to this audience, beginning with statistics and a quick review of equilibrium and solution chemistry. While this material may be too elementary for some, we have discovered that many students in our course are deficient in basic concepts such as significant figures, so such topics are included. The major quantitative techniques covered next are spectroscopy UV and IR, chromatography GC, LC, HPLC, and TLC, and dissolution. Of these, HPLC is unquestionably the most important and is the focus of much of the material throughout the book.

The final chapters cover detectors mainly chromatographic, quantitative analysis, and data systems, plus the special topics of method development based mainly on HPLC, qualification of instruments, and validation and method transfer.

A multiauthor work such as this one runs the risk of being fragmented and uneven. We have tried valiantly to make it as unified as possible, drawing on our shared teaching experience with the LATCP course. It is, of course, impossible to define a single set of symbols when the topics are so diverse. Appendix I lists the terms and symbols used, noting overlaps in an attempt to keep confusion to a minimum. In chromatography, the IUPAC symbols are used, not those of the USP. This anticipates that USP will eventually adopt the IUPAC system in the spirit of unity and international cooperation. Other appendixes include the terms and some procedures used by another international group, ICH.

Being written to accompany the LATCP course, this book is intended for individual use by laboratory analysts. We have attempted to keep it as succinct as possible and provide suffcient detail, given the wide range of subject matter. The editor and the publisher welcome suggestions and comments for future editions.

We want to acknowledge the two persons who are most responsible for initiating and guiding this project: Hank Avallone, Juanita Hawkins and Nancy Corkum. Their vision, commitment, and support were crucial. In addition, we want to acknowledge efforts of the LATCP Managers, Pat Magliozzi and Tom Caglioti.

Each of the authors is lauded for her/his efforts to produce a concise chapter within the limitations of time and page length. We also wish to thank the many content reviewers for their valuable time and expertise. Of course, none of this would have been possible without the tedious clerical support by IRI, especially Diane Kelly, Katherine Miles, and Patty Raymondi.

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The laboratory is an extension of our senses, enabling us to obtain data on substances beyond what we can see with a naked eye and in amounts that our hands could never achieve. These data are compiled into reports and are ultimately used for making decisions, decisions that cannot be confirmed with our unaided senses. The quality of any decision is absolutely dependent on the quality of the data; junk data lead to junk decisions.

The process of acquiring valid data requires properly trained personnel using appropriately calibrated tools. In order to ensure the acquisition of high-quality data, one must be certain that all laboratory tools are suitable for their intended use [i.e., meet their standard operating procedure (SOP) requirements] within their validated limits. In addition, all involved personnel in the data gathering and information generation e¨orts must have the required knowledge, skills, and abilities ( KSAs) to satisfactorily perform their tasks. As has been noted, this is good business practice and, secondarily, necessary regulatory compliance.

In addition, however, our technological industry continues to churn out an ever-expanding array of almost magical analytical technologies, thereby creating a new group of incompetent laboratory personnel who are not familiar with or trained to use them.

Not surprisingly, these expanding technologies have posed a great and insurmountable challenge to our already much maligned educational system. The college/university curriculum continues with the traditional four-year program where the faculties are supposed to inculcate into the students the usual very strong foundation in the basic knowledge and skills of the science, packaged as a palatable academic program. Because all of this knowledge cannot be rationally delivered in a four-year curriculum, the assurance that those who generate data have the basic KSAs falls to the employers. Management must have confidence that all of the employees in the organization possess the required KSAs to perform their assigned tasks. As competent analysts performing in the laboratory reflect on the adequacy of the first-line management team, incompetent analysts in the laboratory reflect the inadequacy of that team.

Because of severe infractions in the practice of good science and science management by several firms, the U.S. Food and Drug Administration found it necessary to issue regulations defining minimum appropriate standards for the performance of nonclinical studies submitted to the agency. This issuance of the ``Good Laboratory Practices'' regulations made the acronyms ``GLPs'' and ``SOPs'' ``household'' words in laboratories throughout the world. Subsequently, the agency issued the related regulations to provide administrative law guidance for pharmaceutical manufacture in the current good manufacturing practices (CGMPs).

In both cases the regulations were intended to provide broad guidance on appropriate scientific practices in the pharmaceutical industry while not stifling innovation and the evolution to superior practices that still satisfy the requirement. These regulations address many aspects of laboratory operations but only broadly address the skills and abilities of the primary practitioners: the management and bench scientists. This deficit was pointed out in ``Analysts: The Unknowns in the Quality Assurance Equation''.y That presentation and many subsequent ones focused on the fact that college science graduates do not in general have all the skills required to competently function in an FDA-regulated environment. This poses a crisis for first-line managers who must have absolute confidence that their staff members possess the required KSAs to competently perform the tasks that they are assigned.

In order to ensure that the scientists have acquired the required competencies to adequately perform their assigned tasks, management must establish quality systems structured to provide necessary training and education. It appears that one company, Johnson & Johnson, has taken a direct approach to meeting this challenge by establishing a laboratory analysts training and certification program for its employees.

This text has emerged from that program. It is designed to establish a basic knowledge and skill base in the technologies that are most prevalent in ``product control laboratories'' of the pharmaceutical industry. The laboratory supervisors who employ the individuals who successfully complete this course can have confidence that they have this well-defined starting point from which they may begin to evolve the individual employee's skills to journeyman performance levels in their specific organization.

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