During the FDA’s November 2016 DSCSA workshop, several participating organizations, including the Generic Pharmaceutical Association (GPhA), asked the FDA if serialized data is considered GMP. It was a simple question, but the answer has deep significance for manufacturers.
GMP stands for Good Manufacturing Practice. The International Society for Pharmaceutical Engineering (ISPE) describes a GMP as a system for ensuring products are consistently produced and controlled according to quality standards. The goal of establishing and following GMPs is to minimize the risks involved in pharmaceutical production, catching flaws or highlighting problems that can’t be eliminated during final product testing. In plain English, a GMP system is any system that runs within the framework of producing and maintaining drug products. For example, Enterprise Resource Planning (ERP), Quality Management Systems (QMS), and material management systems are all GMPs.
What does that mean in the real pharma world if serialized data is considered GMP? Here’s one example: Drug manufacturers that operate under CFR 21 Part 11 compliance would need Computer System Validation (CSV) to adhere to GMP and comply with Part 11. CSV is a time- and labor-intensive process. No GMP means no CSV—instantly saving time and money.
So there was a lot on the line when GPhA asked that question in November. Unfortunately (and unsurprisingly), the FDA provided no answers. That leaves it to the industry to interpret a way forward. In order to help you know what’s right for your organization, let’s back up and paint a clear picture of GMP.
Lifting up the Hood on GMP
In 2006 the FDA issued guidance that set expectations and scope recommendations for the GMP framework. In that release, “Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations,” the FDA explained their “Six-system Inspection Model” and how they would audit manufacturers following such a model. The six systems are:
- Production System
- Facilities and Equipment System
- Laboratory Controls System
- Materials System
- Packaging and Labeling System
- Quality System
FDA personnel are instructed to inspect manufacturers based on the above quality system model. But how does this apply specifically to serialization? Let’s take a look.
Your serial number is first generated in a serialized data repository. The common serial data repositories are ERP, WMS, packaging systems, or a third-party serial data manager system. This means serial data could infringe on four of the six systems in the FDA’s model: Production, Packaging and Labeling, Materials, and Quality systems. If the serial numbers are housed in ERP, WMS, and packaging systems, the answer is simple: They are clearly GMP. The problem arises with remaining system, third-party serial data management. Is that GMP? Before we jump to conclusions, we need to answer some questions.
First, is the third-party system an extension of the packaging and labeling, production, or materials system?
If one of the answers is “yes,” then the third-party system is GMP. If not, we move on to these questions:
- Will the data generated and maintained in the third-party system be part of the production data?
- Will the data generated and maintained in the third-party system be the source or part of the source data for returns and recalls?
- Is the data generated and maintained in the third-party system relevant to pharmacovigilance?
- Will the data generated and maintained in the third-party system be relevant to product investigations?
If you answer “yes” to any one of those questions, then the serialization system is indeed GMP. In short, if you are a manufacturer (virtual or asset based), serialization is a production element, and is therefore GMP.
Now imagine the FDA is visiting your facility—and they have a lot of detailed questions about your serialization system. Do you have clear answers to provide? You should, especially if you don’t plan to validate.
If that scenario concerns you, there’s something you can do: Share your answers with me. We can ensure you’re ready to provide all the information and answers that are required.
GMP Help from LSPediA
Serialization is complex—and now validation is adding more tasks to your to-do list and unknowns to your situation. But the truth is you’re not alone, and most organizations are stretched for resources. It’s worth your time to talk to LSPediA about OneScan Solutions. Our validation packages is one of the best in the industry. That’s LSPediA. We’ll bring our “A game” to your organization and help you fast-track your progress to meet the November deadline. Contact us today.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]