HANDBOOK OF VALIDATION IN PHARMACEUTICAL PROCESSES

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HANDBOOK OF VALIDATION IN...

HANDBOOK OF VALIDATION IN PHARMACEUTICAL PROCESSES

James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell

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ক্যাটাগোরিগুলো:

সাল:

2021

সংস্করণ:

FOURTH

প্রকাশক:

CRC PRESS

ভাষা:

english

ISBN 10:

0367754290

ISBN 13:

9780367754297

ফাইল:

PDF, 33.48 MB

IPFS:

,

english, 2021

অনলাইনে পড়া

ডাউনলোড (pdf, 33.48 MB)

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আপনি আগ্রহী হতে পারেন

McBraun, Steve — Computerized System Validation: Be ready for audit!

Emmet Tobin — A Guide to Process Validation for Medical Devices

ISPE — ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)

ISPE — Practical Implementation of the Lifecycle Approach to Process Validation

ISPE — Technology Transfer

ISPE — ISPE Good Practice Guide: Single-Use Technology

ISPE — ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls

PHARMACEUTICAL STERILE PRODUCT GMP AUDITING MANUAL — PHARMACEUTICAL STERILE PRODUCT GMP AUDITING MANUAL

Steven Shire — Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product

Christopher M. Riley; Thomas W. Rosanske; George L. Reid — Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Sarwar Beg (editor), Md Saquib Hasnain (editor), Mahfoozur Rahman (editor), Waleed H. Almalki (editor) — Handbook of Analytical Quality by Design

Javed Ali, Sanjula Baboota — Regulatory Affairs in the Pharmaceutical Industry

Avis, KennethE — Sterile Pharmaceutical Products : Process Engineering Applications

Jon Voss — Cleaning and Cleaning Validation: A Biotechnology Perspective

Dilip M. Parikh — Handbook of Pharmaceutical Granulation Technology

Sarwar Beg, Majed Al Robaian, Mahfoozur Rahman, Syed Sarim Imam, Nabil Alruwaili, Sunil Kumar Panda, (eds.) — Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design

Dipak Kumar Sarker — Quality Systems and Controls for Pharmaceuticals

Shayne Cox Gad — Handbook of Pharmaceutical Biotechnology

Gad Shayne Cox. (ed.) — Pharmaceutical Manufacturing Handbook Production and Processes

David J. am Ende — Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing

Whyte, W — Cleanroom technology: fundamentals of design, testing and operation

Robert A. Nash, Alfred H. Wachter — pharmaceutical process validation an international

Buncher, Charles Ralph; Tsay, Jia-Yeong — Statistics in the pharmaceutical industry

Orlando Lopez — 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Michael J Akers — Sterile drug products : formulation, packaging, manufacturing, and quality

P. Agalloco James, Frederick J. Carleton — Validation of Pharmaceutical Processes

Rodríguez Pérez José — The FDA and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals

Niazi, Sarfaraz K. — The Future of Pharmaceuticals: A Nonlinear Analysis

Erfan Syed Asif — Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval

Hazel Aranha, Humberto Vega-Mercado — Handbook of Cell and Gene Therapy

Gibson, Mark; Schlindwein, Walkiria S — Pharmaceutical quality by design : a practical approach

Rowe, Philip — Essential Statistics for the Pharmaceutical Sciences

Andrew Teasdale (Editor), David Elder (Editor), Raymond W. Nims (Editor) — ICH Quality Guidelines: An Implementation Guide

Peter Kleinebudde, Johannes Khinast, Jukka Rantanen — Continuous Manufacturing of Pharmaceuticals

Dipak Kumar Sarker — Packaging Technology and Engineering: Pharmaceutical, Medical and Food Applications

Garciá-Munoz, Salvador; Reklaitis, Gintaras V.; Seymour, Christine — Comprehensive quality by design for pharmaceutical product development and manufacture

Hout, Sam A. — Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments

Orlando López — Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Sarfaraz K. Niazi (Author) — Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume One, Compressed Solid Products

Sarfaraz K. Niazi (Author) — Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume Two, Uncompressed Solid Products

Sarfaraz K. Niazi (Author) — Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products

Sarfaraz K. Niazi (Author) — Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume Four, Semisolid Products

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