EurekaMag.com logo
+ Site Statistics
References:
53,214,146
Abstracts:
29,074,682
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on Google+Follow on Google+
Follow on LinkedInFollow on LinkedIn

+ Translate

Systems validation for parenteral clinical drugs application to research and development and quality control laboratories



Systems validation for parenteral clinical drugs application to research and development and quality control laboratories



Journal of Parenteral Science & Technology 37(2): 45-50



The production of parenteral products for clinical use represents unique burdens and problems for quality control [QC] and research and development laboratories [R and D] involved in product development. Since the application of GMP [Good Manufacturing Practices] to QC and R and D laboratory operations is frequently the subject of controversy, this presentation attempts to discuss the FDA [USA Food and Drug Administration] position on this matter. While the FDA does consider that GMP do apply to QC and R and D laboratories involved in clinical drug development, it is recognized that there are legitimate questions about which systems need to be validated and to what degree. The rationale or need for validation is emphasized, and recent FDA experiences are utilized to illustrate problem areas. Some R and D and QC systems for which validation should be considered/required are identified.

(PDF 0-2 workdays service: $29.90)

Accession: 006575809

Download citation: RISBibTeXText



Related references

Systems validation for parenteral clinical drugs--application to R&D and QC laboratories. Journal of Parenteral Science and Technology 37(2): 45-50, 1983

Considerations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research: an EORTC-NCI working group report. International Journal of Oncology 23(6): 1715-1726, 2003

Quality Control Systems In Clinical Chemistry Laboratories. Postgraduate Medicine 34: A58-A70, 1963

Simultaneous determination of antiepileptic drugs in clinical laboratories: Problems of quality control and standardization. Journal of Clinical Chemistry and Clinical Biochemistry. Zeitschrift für Klinische Chemie und Klinische Biochemie 17(1): 35-43, 1979

Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories. Chinese Journal of Physiology 57(2): 63-68, 2014

Simultaneous determination of anti epileptic drugs in clinical laboratories under routine conditions problems of quality control and standardization. Journal of Clinical Chemistry & Clinical Biochemistry 17(1): 35-44, 1979

The practice of development and implementation of quality management systems in medical laboratories. The GOST R ISO 15189-2009 "medical laboratories. The detailed requirements to quality and competence". Particular difficulties of global nature. Klinicheskaia Laboratornaia Diagnostika: 41-45, 2013

Quality control and the standardization of laboratory research methods is the basic way to improve the performance of clinical diagnostic laboratories. Laboratornoe Delo: 135-137, 1979

European Communities Confederation of Clinical Chemistry: essential criteria for quality systems of medical laboratories. Working Group on Harmonisation of Quality systems and Accreditation. European Journal of Clinical Chemistry and Clinical Biochemistry 35(2): 123-132, 1997

Additional Essential Criteria for Quality Systems of Medical Laboratories. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation. Clinical Chemistry and Laboratory Medicine 36(4): 249-252, 1998

Quality control validation in veterinary laboratories. Veterinary Clinical Pathology 28(4): 150-155, 2002

Quality control validation in veterinary laboratories. Veterinary Clinical Pathology 28(4): 150-155, 1999

A perspective on the development of regulatory policy regarding personnel standards, quality control, and proficiency testing for clinical laboratories. American Journal of Medical Technology 46(2): 131-133, 1980

Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation. Clinical Chemistry and Laboratory Medicine 38(10): 1057-1064, 2001

A quality management model for the development, evaluation, and validation of clinical chemistry systems. Clinical Chemistry 41(S6 PART 2): S208, 1995