Cleaning Validation

Cleaning validation ensures the implementation of an efficient cleaning procedure, which excludes "cross-contamination" between different products or different batches of the same product.

Another definition of the concept of cleaning validation, which is controlled through a separate master plan, is a tool that provides documented evidence that a cleaning procedure is effective in reducing, to predefined maximum allowable limits, all kinds of contamination from an item of equipment or a manufacturing area following processing. The means of evaluating the effectiveness of cleaning will involve sampling cleaned and sanitized surfaces and verifying the absence of product residues, cleaning residues, and bacterial contamination.

Regulatory agencies as well as pharmaceutical industries have placed a great deal of emphasis on the validation of cleaning procedures during the last decade. Various agency documents have clearly established that cleaning procedures should be validated.

In order to prevent contamination, Food and Drug Administration (FDA), in its 1963 GMP Regulations (Part 133.4), stated, "Equipment shall be maintained in a clean and orderly manner." A very similar section on equipment cleaning (211.67) was included in the 1978 CGMP regulations.

FDA emphasizes on the validation of the cleaning procedures, particularly in cases where contamination of materials poses the greatest risk to the quality of drug products. Validation of cleaning procedures should reflect actual equipment usage patterns. If a number of products are manufactured in the same equipment and the same procedure is used to clean the equipment, a worst-case product can be selected for validation purposes based on the solubility and difficulty of cleaning and the calculation of residue limits based on potency, toxicity, and stability.

A descriptive protocol should be available to indicate the type of samples to be obtained. The sampling method used may be swab, rinse, or direct extraction, as appropriate, to detect both insoluble and soluble residues. The sampling methods used should be capable of quantitatively measuring the levels of residues remaining on equipment surfaces after cleaning.

Your Company's L

Your Company's L

Your Company's N

Your Company's N

Was this article helpful?

0 0
Healthy Chemistry For Optimal Health

Healthy Chemistry For Optimal Health

Thousands Have Used Chemicals To Improve Their Medical Condition. This Book Is one Of The Most Valuable Resources In The World When It Comes To Chemicals. Not All Chemicals Are Harmful For Your Body – Find Out Those That Helps To Maintain Your Health.

Get My Free Ebook


Post a comment