Have you validated your analytical test method used for cleaning samples?

July 14

According to the Code of Federal Regulations (21 CFR 211.67 Equipment Cleaning and Maintenance), facilities must have an effective equipment cleaning program.  Furthermore, To ensure your equipment is clean, you must verify by taking samples during the cleaning process. These sample must be tested using an analytical test method. These methods must be validated.

A company recently received the following observation:

…. Test methods used for the verification of cleaning of production equipment are not established.

Specifically,

a.         The firm uses unvalidated analytical test method to perform routine equipment cleaning verification. The analytical test method currently used to quantify the residual products on cleaning are tested with Thin Layer Chromatography (TLC) method. This TLC method originally developed to determine completion of … in step during manufacturing process. This TLC method has not been demonstrated to quantify to the levels of the cleaning validation requirement, detection limit of … ppm.

b.         Cleaning validation of … utilized UV-Visible Spectrometric method …. However, currently the company utilizes a TLC method for rinse sample tests for equipment cleaning verification. This method was never verified and hence no assurance that the production equipment is completely free from API or degradants as a proper analytical method is not used.

According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to equipment cleaning (21 CFR 211.67(a), and 21 CFR 211.67(b)) have been in the top 10 observations cited by the FDA each year.

For more information on FDA’s expectations regarding equipment cleaning, refer to Validation of Cleaning Processes.

To view more observations pertaining to equipment cleaning, refer to the following GMP Trends® Issues: 1111, 1096, 1052, 1033.

For more observations pertaining to manufacturing controls, see our new Issue 1116 available today.  It also has observations pertaining to quality systems, API manufacturing controls, and medical devices.

Stay in Compliance! Subscribe today!

Stay in Compliance!

To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else!

LEARN MORE
About GMP Trends

GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

Available Reports
Stay in Compliance!

Sign up for free highlights and updates from GMP Trends


Report Categories
Recent Posts
Recent Comments
    Archives
    Categories
    Meta

    Become A Subscriber And Stay Ahead of the FDA

    To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

    SUBSCRIBE NOW