FDA 483: Keeping your Quality Control Lab Compliant

White Paper: FDA 483s and Non-compliance in Pharma

The United States Food and Drug Administration (FDA) has the authority to inspect pharmaceutical companies that manufacture FDA-regulated products at any time and write down their observations on Form FDA 483.

An FDA 483 tells a company which areas to improve in, or correct, in order to remain compliant and stay operational. Once a 483 is issued, officials may conclude that serious violations could exist, and a warning letter is then issued.

In pharmaceutical drug production, 483s are issued for:

• Failure to follow written procedures
• Failures in laboratory controls
• Faulty production record reviews
• Absence of written procedures
• Improper cleaning
• Improper sanitization
• Improper maintenance

Drug Production Compliance and QC

It’s established that 483s are an essential tool for keeping up the high standards of compliance and quality management required of companies that produce drugs. In some cases, 483s may lead to product recalls, in other cases recalls arise post-distribution and results from adverse event reporting.

Microbial contamination is one of the most common reasons for a recall to be issued. The root causes of microbial contamination is found in the raw materials or in the final product. Most come from the environment not being sufficiently sterile or from water that is being used.

If the water being used in the manufacturing and formulation of the final product meets regulatory compliance; this being CFR 21 Part 11, USP 643, and USP 645 regulations, the less likely it is that the water itself will be contaminated.

Water Purification for QC Success

Compliance becomes especially important when it comes to the design, installation, and maintenance of the water purification systems needed in pharmaceutical processes. The role of water in drug manufacturing and production means that the quality control processes must be stringent so that the water can be immediately eliminated as a root cause when issues arise.

USP reviews are available to help in the design, operation, and maintenance of an effective pharmaceutical water treatment system and microbiological testing program to prevent microbial contamination in the first place. Including the establishment of alert and actions levels as part of SOPs for testing, validating and troubleshooting, sanitization procedures for all pharmaceutical water systems. This effective implementation of SOPs is possible with the use of water purification systems that meet CFR 21 Part 11 requirements.

Water is unique in its vast contribution and impact across pharmaceutical processes. The monitoring and maintenance of the correct levels of water purity in all these processes, including the use of water purification systems that are compliant, can only contribute positively toward ensuring continued trust and confidence in the pharmaceutical industry.

Continue reading the ELGA White Paper, FDA 483s and Non-Compliance in Pharma, to learn more.

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