How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process

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Description

How to Validate a Pharmaceutical Process provides a "how to" approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the "why" is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.
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Product details

  • Paperback | 218 pages
  • 152 x 229 x 12.7mm | 360g
  • Academic Press Inc
  • San Diego, United States
  • English
  • black & white illustrations
  • 012804148X
  • 9780128041482
  • 760,957

Table of contents

Preface



Introduction
New & Legacy Products

The three phases of PV

What it will attempt to do

Product Status

Section I - What is Process Validation and Why do Process Validation?

Defining Process Validation


Risk Based Approach
Good Science

Brief Review of the Regulations and Guidelines


21CFR
ICH
Other regulatory information

The Role of Change Control
Section II - Stage I - Process Development

Starting the Process Validation Program


Validation Master Plan
SOPs
Quality Programs

Equipment and Utility Qualification


Determining what needs to be done


Direct
Indirect
System Boundaries

Commissioning
Qualification


IQ
OQ
PQ


Dealing with Computers and Automation Validation


General Computer System Validation
Part 11

Process Development


Risk Assessment
Process Description (Defining the process)
Critical v. Non-Critical
Determining CPPs and CQAs
What variables are in the process


Why are they variable?
Can they be controlled?


Section II - Process Qualification

The Process Validation Protocol


What makes a good protocol
Sampling Plans for Process Validation
Conducting the Process Validation protocol


Solid Dose
Creams, Liquids and Ointments
Parenterals

Preparing theProcess Validation report

Dealing with Deviations


Investigations
Resolution

Section III - Continued Process Verification

Collecting and Evaluating Production


Use of Control Charts

Use of Statistical Process Control - pPk, Pk, cPk, cP
Section IV - Other Related Activities

Cleaning- Verification to Validation
Facility Qualification
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About Steven Ostrove

Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations.
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