When choosing a company to manufacture your pharmaceuticals, there are so many different aspects to consider. Aside from the bottom-line pricing, product safety and quality are the biggest drivers of deciding whether to contract with a manufacturing company.

The FDA’s regulations offer a systematic framework for companies to follow to ensure that their products are of the highest quality and safety. The FDA warning letters companies might receive are then a result of inspections and any noncompliance with established standards. Over the years, more warning letters have been issued because an aging American population and an increasing need to address chronic diseases has prompted growth in research and development in pharmaceuticals and medical technologies.

Before the addition of the Quality System Regulations in 1997, the FDA found that about 44% of quality issues leading to voluntary recall actions were attributed to deficiencies in product design that would have been prevented with better controls. The general trend has been an increase in violations in design control which shows increasing FDA’s emphasis on it. The quality systems fall in five categories:

• Production and process controls – Production and process controls relate to establishing and maintaining procedures to document, monitor, and verify compliance of the manufacture of the product. These processes are applied to all phases of production beginning with initial purchase and receipt of raw materials and/or parts and extending to the sale, distribution, installation, and servicing of the finished product.
• Corrective and preventive actions – CAPAs relate to establishing and maintaining procedures for investigating non-conformances, identifying actions to address these, and verifying that these actions are effective. 
• Design controls – Design controls involve the establishment and maintenance of procedures to control the design of the device to ensure that the specified design requirements are met.
• Management controls – Management controls refer to policies, organizational structure, resources, personnel, and internal review of the quality system.
• Document controls – Document controls relate to procedures for documenting device and batch-/lot-specific specifications and production processes, as well as those for document approval, distribution, and changes.

The Difference Between Form 483 and a Warning Letter

After an inspection, the FDA usually issues Form 483, which details inspectional observations. The form is used as a guide for voluntary corrective action with a response from the company required within 15 working days.

It is not a final determination of whether the business is in violation of any regulations. On the other hand, a warning letter states the exact regulation of which the company is in violation. The warning letter has the potential to have an impact on requests by the company for certain licenses or applications. The FDA can also take legal action if the concerns in the letter are not addressed.

The Most Common Warning Letter – Failure to Follow Standard Operating Procedures (SOPs)

Just like any other organization, the FDA has limited resources. This means that when they inspect a company, one of the biggest aspects they focus on is the standard operating procedures because the foundation of the quality system is a set of SOPs that are meant to be followed to ensure compliance with regulations. The consensus is that if a company does not take compliance with SOPs seriously, they will not take other regulatory compliance seriously either.

Why Oakwood Labs Is the Best Choice for a CDMO Partner

Oakwood Labs maintains rigorous in-house quality systems, including Quality Assurance and Validation, QC Microbiology, and QC Chemistry. Our team is highly committed to quality and has a long history of compliance.

Quality Assurance/Validation

We have a documented Quality Management System (QMS) designed and implemented to fulfill the following regulatory requirements:

• FDA 21 CFR Part 210 and 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
• FDA 21 CFR Part 4, Regulation of Combination Products
• FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
• ICH Q10 Pharmaceutical Quality System

Need a Trusted Partner for FDA Compliance? Contact Us

If you want to ensure that your operations avoid running afoul of the FDA, let the experts at Oakwood Labs help. Reach out to our team today to discuss project details and we can get to work developing workable solutions.