Analytical Chemistry in a GMP Environment: A Practical Guide / Edition 1 available in Hardcover
Analytical Chemistry in a GMP Environment: A Practical Guide / Edition 1
- ISBN-10:
- 0471314315
- ISBN-13:
- 9780471314318
- Pub. Date:
- 05/01/2000
- Publisher:
- Wiley
Analytical Chemistry in a GMP Environment: A Practical Guide / Edition 1
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Overview
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
Product Details
| ISBN-13: | 9780471314318 |
|---|---|
| Publisher: | Wiley |
| Publication date: | 05/01/2000 |
| Pages: | 512 |
| Product dimensions: | 6.44(w) x 9.27(h) x 1.19(d) |
About the Author
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.
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.).
Appendices.
Index.
Foreword
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.