“Learn the consequences of failing to comply with FDA Part 210 cGMP guidelines. Understand FDA penalties, public health risks, and how to ensure compliance.”
The Price of Failure of Non-Compliance with FDA Part 210
The Food and Drug Administration (FDA) is an eighteenth century federal agency that protects the public health through the regulation of systemic safety, efficacy, and security for all human and veterinary drugs, biological products, medical devices, our nation′s food supply, cosmetics, dietary supplements [and] electronic radiation–emitting products.
FDA Part 210
General cGMP Requirements for Finished Pharmaceuticals. These regulations ensure that drugs are to be produced in a controlled and sanitary environment while also meeting the quality criteria laid down by FDA.
If companies do not comply with the FDA Part 210, both they and the public may face dire consequences. For the company, non-compliance means putting at risk leading to:
FDA warning letters
FDA product seizures
FDA injunctions
FDA fines
Civil lawsuits
Criminal prosecution
For the public, FDA Part 210 noncompliance can lead to: Injuries, Illnesses ,Deaths
Failure to comply specifically with FDA Part 210 can result in complete classes of drugs being recalled. The FDA pulled all ranitidine products, including this common heartburn medication in 2008 because they were contaminated with a known carcinogen. Several drug manufacturers were found to be non-compliant with regard to FDA Part 210, resulting in the recall.
Drug manufacturers must be serious about FDA Part 210. These guidelines are there to aid companies in making sure their products are safe and effective, protecting the public health.
Below are some steps companies can take to help ensure they remain compliant with FDA Part 210:
Consult one of the best and highly professional consulting firms to assist you with your FDA compliant concern. They can assist you to:
Establish a full cGMP programme and its implementation
Educate staff on cGMP standards.
Carry out frequent audits to ensure that standards are met.
Document all cGMP activities.
Contact the FDA at once if you see any violations.
By taking these types of actions, companies will increase the likelihood that they help to protect the public health and avoid possessing results similar to those resulting from non-compliance with FDA Part 210.
Reach out to BioBoston Consulting today or visit our website to find out how we can help your organisation.
