An Easy to Understand Guide to Cleaning Validation

  • 0

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.

Learning Objectives

  • 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
  • Pre-requisites
  • Cleaning Validation Strategy, Plan & Policy
  • Sampling
  • 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
  • Deviations
  • Clean and Dirty Hold Times
  • Validation Report
  • Post Validation Monitoring
  • Maintaining the Validated Status
  • Retrospective Cleaning Validation

Purchase a Copy Today

Click here to purchase a copy of “An Easy to Understand Guide to Cleaning Validation”


Similar articles:

7 Top Tips for Validating Computer Systems in a Regulated Environment [Video]

The validation of any computer system in a regulated environment is always a tricky task with so many areas to cover. Not only do you have to ensure that the application adheres to 21 CFR Part 11 but it must also be validated to ensure that data integrity is not compromised throughout it’s life cycle.

To help you successfully validate a computer system remember the following:

1. Development Methodology

Select a development methodology that best suits the nature of the system – the risk analysis you do will help decide what level of validation is required.

For example, if you purchase the system from a third party vendor you may be able to leverage some of the testing they have already performed to streamline the effort.

2. Hardware

Select hardware based on capacity and functionality – vendors and IT personnel will guide this part of the process.

3. Opertional Limits

Identify operational limits to establish production procedures

4. Opertional Functions

Identify operational functions associated with the

  1. Users
  2. Processes
  3. Regulations
  4. Company standards
  5. safety requirements

5. Worst Case Scenrios

Identify and test worst-case production scenarios

6. Master Validation Plan

Clearly document the validation process and start by creating a master validation plan to define the effort involved

7. Written Procedures

Ensure the availability of written procedures to maintain the validated state of the computer system.

21 CFR Part 11 - Electronic Records

This video is taken from our online course on 21 CFR Part 11 – Electronic records. Click here to find out more about this course.


Similar articles:

The 9 Golden Rules – Ensuring Laboratory Data Integrity [Video]

The enduring assets of a laboratory’s work are the records that document those activities. When laboratory records are used to support a regulatory function, they are considered to be legal documents.

For records to be considered reliable and trustworthy they must comply with the following criteria:

1. Legible and Understandable

They must be able to be read and understood for the lifetime of the record, without having to refer to the originator for clarification. The information may be needed in five, ten or twenty years’ time, perhaps after the originator is no longer available.

2. Attributable

Who made the record or created the data and when?

3. Contemporaneous

The record must be made at the time the activity was performed

4. Original

The information must not be written on a post-it, piece of scrap paper, sleeve of a lab coat etc. and then transcribed.

5. Accurate

No errors or editing without documented amendments.

6. Complete

All the information and data associated with the analysis is included.

7. Consistent

All elements in the sequence of analysis must be date & time stamped and must be in the expected order.

8. Indelible

Records are made on to controlled documents, such as laboratory notebooks or controlled worksheets, or saved to electronic media.

9. Available

Over the entire lifetime of the record for review, audit and inspection.



Similar articles: