Validated Cleaning Technologies for Pharmaceutical Manufacturing

Destin A. LeBlanc (Autor)

Buch | Softcover

304 Seiten

2019
CRC Press (Verlag)
978-0-367-39887-3 (ISBN)

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Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

LeBlanc, Destin A.

o Cleaning Objectives. Cleaning and Cleaning Agents. Cleaning Methods. Process Parameters in Cleaning-Part I. Process Parameters in Cleaning-Part II. Cleaning Cycle Development. Grouping Strategies. Setting Acceptance Criteria. Analytical Methods for Cleaning Validation. Sampling Methods for Cleaning Validation. Microbial Issues in Cleaning Validation. Change Control and Revalidation. Special Topics in Cleaning Validation. FDA Expectations. Appendices.

Erscheinungsdatum	24.09.2019
Verlagsort	London
Sprache	englisch
Maße	152 x 229 mm
Gewicht	453 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	0-367-39887-7 / 0367398877
ISBN-13	978-0-367-39887-3 / 9780367398873
Zustand	Neuware