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Your Serialization Project Might Be Missing the Most Important Document Needed for Success

By December 13, 2016March 16th, 2021DSCSA, Serialization

A quality agreement defines the relationship between a company and its contract organization, laying out the rules for how they will do business together. In a highly regulated industry like pharma – with strict compliance laws and many responsibilities to keep track of – quality agreements are vitally important.

“FDA is adamant that everyone throughout the supply chain is responsible for quality,” explained Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, “and that the owners of a drug and contract facilities should work together proactively – under a quality agreement — to control risks to product quality and patient safety.”

Mr. Sklamberg and many others in the industry believe that a well-drafted quality agreement for contract manufacturing will:

  • Promote and improve communication between the parties
  • Clearly delineate the parties’ responsibilities, especially with respect to quality issues
  • Assure coverage of all critical steps needed to ensure the quality of products

Quality Agreement Guidance from FDA

On November 22, 2016, FDA published the final Guidance for Industry – Quality Agreements. It addressees how parties involved in the contract manufacturing of drugs can utilize quality agreements to outline their responsibilities and assure drug quality, safety, and efficacy.

Their guidelines recommend that quality agreements include these five sections:

  1. Purpose/scope — to cover the nature of the contract manufacturing services to be provided
  2. Definitions — to ensure that the owner and contract facility agree on precise meaning of terms in the quality agreement
  3. Resolution of disagreements — to explain how the parties will resolve disagreements about product quality issues or other problems
  4. Manufacturing activities — to document quality unit and other activities associated with manufacturing processes as well as control of changes to manufacturing processes
  5. Life cycle of, and revisions to, the quality agreement

Serialization’s Most Important Document: CMO Quality Agreement

Outsourcing in the pharma industry is trending up – with good reason: CMOs are masters of efficiency, saving the developer time and money, allowing them to focus on drug research and development. But while CMO engagement in the traditional cGMP sense is a tried and trusted model, the DSCSA changes that game completely.

Here’s why: The DSCSA puts the ultimate responsibility for serializing drug products on the shoulders of manufacturers, but many manufactures are at the mercy of the CMOs when it comes to compliance.  Without a sound quality agreement, the entire serialization project is in jeopardy. I’ve seen this problem play out in my own business.

True story: I was commissioned to perform a CMO serialization gap analysis by a pharma company. But when I called the CMO, they refused to engage. When I asked why, the CMO cited that they are not required to collaborate on serialization because the quality agreement didn’t cover it.

Protect Your Business, and Your Product

Pharmaceutical manufacturing does not run on handshakes. It runs on quality agreements. It’s the single most important document in the serialization world – and you must have one in place (harmonized with the FDA guidelines) before any other work starts. If you don’t have one yet, or need help preparing your quality agreement, LSPediA is here for you.

Partner with LSPediA for CMO Management and Regulatory Compliance

How do you align CMOs to your objectives? What technologies does you CMO need? How do you exchange serialized data with a CMO?

Working with LSPediA on serialization means you have a partner with deep experience and a complete understanding of the entire serialization process, including:

  • Developing a quality agreement with key DSCSA responsibilities in compliance FDA guidelines
  • Ensuring CMOs stick to agreed-upon deadlines and responsibilities
  • Designing and optimizing packaging, QA, and warehouse processes

And our RxChain solution is a perfect, 2-in-1 fit for both manufacturers and CMOs that provides:

  • Level 4 Enterprise Serialization for Track-n-Trace
  • Level 3 Edge Warehouse for scanning, shipping, and reconciliation

Plus, the benefits you gain by partnering with us go beyond the serialization process, extending across your organization to:

  • Lower overall serialization spending by reducing the number of redesigns
  • Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
  • Shorten your project timeline by removing trial-and-error process

Contact us today and we’ll create a serialization strategy that’s right for your manufacturing business and tailored to your CMO partnerships.


About LSPediA

LSPediA is a leading management consulting company in the field of DSCSA and Global Serialization with a successful track record and 100% repeat business from our clients. We pride ourselves on the fact that our clients invite LSPediA back to work on future projects: an indication that we’ve done it right the first time. This is the service and the promise that we offer and stand by – We Do It Right The First Time.

We value long term relationships and work hard with clients’ internal teams to properly define the roadmap, architectur,e and systems that align best with their business goals, ultimately bringing our clients the maximum value both now and into the future.

Contact us today to get a boost for your DSCSA and Serialization