Cleaning Validation Overview

Overview & History

Pharmaceutical cleaning validation is the process of verifying that cleaning procedures for equipment and facilities used in the manufacture of pharmaceutical products are effective in removing any residue from previous products. This is done to ensure that the equipment is properly cleaned, and that no contamination occurs between batches of different products. The process typically involves the use of analytical methods, such as swabbing and rinsing, to collect samples of residue from the equipment and then testing those samples to determine if they meet established acceptance criteria. The results of the validation are used to confirm that the cleaning procedures are effective and to make any necessary adjustments to the procedures.

The history of cleaning validation in the pharmaceutical industry can be traced back to the early 1980s. At that time, the Food and Drug Administration (FDA) began to focus more closely on the issue of cross-contamination between batches of different products. This was in response to a number of reported incidents in which contamination had occurred, leading to product recalls and other problems.

In 1983, the FDA issued a guidance document called “Guideline on General Principles of Process Validation” which described the agency’s expectations for process validation, including cleaning validation. This document provided manufacturers with the general principles for demonstrating that a process is capable of consistently producing a product meeting its predetermined specifications.

In the following years, the FDA issued additional guidance documents on cleaning validation, including “Guideline on Sterilization Validation for Terminal Sterilization” and “Guidance for Industry: Process Validation: General Principles and Practices,” which provided more detailed information on the requirements for cleaning validation.

In recent years, the industry has continued to develop new technologies and methodologies to improve the efficiency and effectiveness of cleaning validation. The focus has been on using rapid and sensitive analytical methods, such as PCR and ELISA, to detect low levels of residue, and on using statistical methods to evaluate the results of the validation.

Cleaning validation has a history of evolving with the industry standards, as it’s a crucial part of the pharmaceutical industry to ensure that the product is safe and free from contamination. The Experts at MEDVACON have experience developing from scratch and revamping existing client’s cleaning validation programs.

Cleaning validation is governed by several regulations, including:

• The Food, Drug and Cosmetic Act (FD&C Act) and regulations: The FD&C Act and regulations require that manufacturers ensure that their products are safe and free from contamination. This includes the requirement for cleaning validation to ensure that equipment used in the manufacture of products is properly cleaned and that there is no cross-contamination between batches of different products.
• Current Good Manufacturing Practice (cGMP) Regulations: The cGMP regulations provide the general principles for the proper design, monitoring, and control of manufacturing processes. This includes the requirement for cleaning validation as part of process validation to demonstrate that the process is capable of consistently producing a product meeting its predetermined specifications.
• International Conference on Harmonization (ICH) Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients (API): This guidance provides recommendations for the GMP of API, and includes requirements for cleaning validation.
• The United States Pharmacopeia (USP) <1058> Residual Solvents: This general chapter provides guidelines for the control of residual solvents in pharmaceutical products, and includes requirements for cleaning validation.
• Good Laboratory Practice (GLP) Regulations: These regulations provide guidelines for the proper conduct of laboratory studies and include requirements for cleaning validation when conducting studies to support a new drug application.
• The European Union Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: This guideline provides recommendations for the GMP of medicinal products and includes requirements for cleaning validation.