Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles.
What are the top 483 observations involving laboratories over the past five years (2018-2022)?
The laboratory is a critical element of a human drug GMP site. Laboratory roles include testing raw materials, conducting in-process tests, and analyzing finished products. Laboratory controls (which include specifications, standards, sampling plans, and test procedures) to ensure that components, drug products, in-process materials, etc., conform to standards of identity, strength, quality, and purity are a regulatory expectation, not to mention, best practice.
But are your laboratories up to par per FDA investigator expectations?
With Redica Systems data, we are able to help our customers find this answer within a few steps.
We headed over to the Reports section and ran a 483 Observation Report for the past 5 years (2018-2022). 2,825 observations and deficiencies were found in this time period for 483s containing Laboratory as the primary issue.
The top laboratory-related 483 observations for human drugs GMP from the period of 2018-2022 are as follows:
Interestingly, laboratory controls are also one of the top four common inspection findings found in 483s issued following pre-approval inspections. They are also a common inspection finding by inspectors from other regulatory agencies, not just FDA. If your site manufactures cell and gene therapy products, laboratory controls will be one of seven key systems FDA investigators will evaluate.
Stay on Top of Laboratory Enforcement Trends with Redica Systems
Robust laboratory operations is integral to ensuring product quality. It is important to stay on top of key enforcement trends in this area. This is how Redica Systems can help. Our actionable intelligence can give you insights into what inspectors are most concerned about recently when it comes to laboratory operations, even beyond laboratory controls.
With our data analytics, you can identify which laboratory systems you need to upgrade and which processes need to be enhanced. This enables you to take a proactive approach to quality and compliance instead of a reactive approach, such as making changes only after receiving a 483.
Contact us today to learn how Redica Systems can help you ensure your laboratory operations are top-notch.
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