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FDA Quality Audits: What You (and Your CMO) Should Be Doing

Many companies dread FDA quality audits…even when they’ve invested the preparation, long-term vigilance and dedication to quality to make them a success. The growing number of pharma and biotech firms that work with CROs and CMOs may worry about them the most – suffering concerns that their success is in someone else’s hands. Whether the contract organization is across town or on another continent, however, doesn’t raise or lower the anxiety – it’s the perceived lack of control over their manufacturing or research partner that can cause apprehension.

For companies outsourcing services – anywhere around the globe – selecting the best contract manufacturer or research firm is critical. And as the product heads towards commercialization, regulatory affairs become a priority in that selection process.

Here are a couple of things you should consider about the roles you and your CMO/CRO will play in the quality process:

  • Understand the Quality Audit
    It is critical that companies – even those that outsource entirely – have a solid understanding of the regulatory process. Knowing what to expect helps you evaluate the capabilities of your partner.

Outsourcing pharma and biotech companies need to pay attention to a number of key problem-areas, including:

  • Inadequate information on product development, processes, or analytical methods
  • Poorly-executed technology transfer
  • Failure to address Out-Of-Specifications (OOS)
  • Process and cleaning validation issues
  • Deviation from Quality systems or GMPs.

Top CROs, CMOs and API suppliers will have a keen understanding not just of FDA Quality audits, but of regulatory systems worldwide, and how they integrate & work with one another.

Understand Your Contract Partner’s Approach to Regulatory

Quality should always matter to your CRO, CMO or supplier – beyond the scope of audits and inspections. A reliable CMO should be able to point to a proud history of regulatory success, coupled with commercial success (always a focus). Emphasizing quality shouldn’t be a catchphrase during inspections – quality should be the core emphasis of the organization you choose to commercialize your product.

Neuland has found the Three Steps to a Successful FDA Quality Audit are:

1. Implementing Quality Early in Product Development
At Neuland, we have a fully-equipped R&D facility that develops process and analytical methods. We also have an experienced team dedicated to technology transfer from R&D through manufacturing. And regardless of the manufacturing stage, all products are produced in-line with the Company’s quality system (per ICH Q-7) to maintain quality consistency at every stage of drug development and commercialization. It’s crucial that a contracting organization implements quality measures early in product development to reduce the likelihood of delays or regulatory difficulties at later stages.

2. Building Strong Client Communications
Pharma companies have very real concerns about the costs, timelines and infrastructure requirements of their products and candidates. A contract partner should perform risk assessments for each product and communicate clearly with clients to develop strategies to reduce quality-related risks.

3. Maintaining Quality as an Organization
As I mentioned earlier, quality doesn’t end when the inspection does.  Any Out-Of-Specifications (OOS) should be fully investigated, and appropriate CAPA (Corrective Actions & Preventative Actions) must be developed and implemented.  Process and cleaning validation needs to be performed on each product as per APIC guidelines, and support for regulatory or DMF queries should be provided.

How much emphasis does your company place on quality and regulatory excellence when selecting a contract research or manufacturing partner?


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