This book describes how to comply with equipment cleaning validation regulations and guidelines successfully for activities related to or in support of the manufacture of drug products and substances (and their associated components produced for consumption by humans and animals).
Following the instructions in this book will ensure that you develop and document your cleaning validation processes in a consistent, understandable and traceable manner.
The rules and guidelines in this book are either a direct reflection of the “predicate rules” (the legislation governing the industry) or are best practices used within the industry. Although written primarily with the pharmaceutical and biotechnology industries in mind (two of the most highly regulated industries), these guidelines and good practices can be deployed anywhere.
- Discuss the principles of cleaning validation;
- Understand regulatory requirements and expectations;
- Understand validation requirements;
- Decide which equipment and process require validation;
- Review testing methods used for cleaning process validation;
- Understand different sampling methods;
- Determine cleaning validation acceptance criteria;
- Develop cleaning validation protocols for cleaning processes;
- Create validation reports;
- Understand the need to maintain a validated status.
What Will You Learn?
Upon the completion of this book you will be able to, discuss the principles of cleaning validation, understand regulatory requirements and expectations, understand validation requirements, decide which equipment and process require validation, review testing methods used for cleaning process validation, understand different sampling methods, determine cleaning validation acceptance criteria, develop cleaning validation protocols for cleaning processes, create validation reports and understand the need to maintain a validated status.
Who Should Read This Book?
At around 82 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about cleaning validation or want to brush up on your current knowledge this book is made for you!
We’ve broken down this book into 24 key sections:
- What is Cleaning Validation?
- Regulatory Requirements
- The Scope of Cleaning Validation
- The Cleaning Validation Sequence
- Cleaning Validation Strategy, Plan & Policy
- Recovery Studies
- Analytical Method Selection and Development
- Analytical Method Validation
- Acceptance Criteria
- Cleaning Method Development
- Validation Master Plan
- Cleaning Validation Plan
- Cleaning Process Standard Operating Procedures (SOP)
- Cleaning Validation Protocols
- Protocol Execution
- Clean and Dirty Hold Times
- Validation Report
- Post Validation Monitoring
- Maintaining the Validated Status
- Retrospective Cleaning Validation
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