Vol 7: Mastering the Art of Regulatory-Driven Specification Setting: A Creative Approach

February 01, 2023The Pathfinder 14 Min Read

Mastering the Art of Regulatory-Driven Specification Setting: A Creative Approach


The U.S. Food and Drug Administration (FDA) provides regulatory guidance on setting specifications for medical devices, food safety, and other products they regulate. This guidance outlines the appropriate levels of testing, validation, risk management, and quality assurance that must be met. Understanding these requirements is essential for staying in compliance with federal law and coming up with creative ways to meet them.

One-way sponsors can use FDA guidelines to their advantage is by establishing performance criteria tailored specifically for their product or process. While FDA regulations may set certain thresholds, sponsors can add additional details that apply only to their production practices or procedures. This allows them to create more precise specifications that are tailored specifically for their products or services – something the FDA may not have anticipated when creating their regulations.

At its core, the FDA provides detailed guidance on how products should be made, tested, validated, risk managed, and quality assured – all within federally mandated thresholds. This can seem overwhelming if you’re not familiar with the nuances of the regulations or have limited knowledge regarding interpretation of those standards; however, having a deep understanding of these requirements allows for more precise specifications tailored specifically for your product or process.

Additionally, it’s important to keep an eye out for updates or revisions as new technologies become available or industry initiatives evolve over time – adhering to these changes helps ensure compliance with federal law despite any modifications that may occur along the way.

Ultimately, setting specifications using current FDA guidance doesn’t have to be mundane or restrictive – there are plenty of opportunities for creativity here! By taking the time to understand the nuances expected by the agency and then applying them thoughtfully in a way that works best for your business processes, everyone can benefit from high levels of protection while still fostering innovation within their own operations.


Setting Specifications and Interpreting Current FDA Guidance


Setting specifications for pharmaceutical products is an important step in ensuring their quality and safety. Specifications help define the acceptable range of a product’s physical, chemical, and biological attributes, and ensure that the product meets its intended use.

Expectations for specifications are outlined by the FDA in their guidance documents. These expectations serve as the basis for quality control and assessment during the manufacturing process and throughout the product’s lifecycle.

Current FDA guidance focuses on two main areas: the development of product specifications and the interpretation of specifications during product testing.

The development of product specifications should take into account the intended use of the product, the formulation, the manufacturing process, and any available data on product variability. The specifications should be based on sound scientific principles and should be reviewed and updated regularly to reflect changes in the product or its manufacturing process.

When interpreting specifications during product testing, the FDA expects that product testing should be performed using validated methods and in accordance with established specifications. The results of the tests should be compared to the specifications to determine whether the product meets the expected standards. If the product does not meet the specifications, the manufacturer should determine the root cause of the issue and take appropriate corrective actions.


Specific Specification Requirements


The FDA has specific requirements for various dosage forms when it comes to setting specifications. Some of these requirements are:

  • Tablets and capsules: Specifications for tablets and capsules should include parameters such as weight, thickness, hardness, disintegration, and dissolution. The FDA also requires that these dosage forms meet specific standards for uniformity of weight and content.
  • Injectable products: Injectable products should have specifications for parameters such as clarity, pH, and particulate matter. Additionally, the FDA requires that injectable products be free from visible particles and be sterile.
  • Topical products: Specifications for topical products should include parameters such as viscosity, spread ability, and stability. The FDA also requires that topical products be free from visible particles and have appropriate uniformity of dose.
  • Ophthalmic products: Ophthalmic products should have specifications for parameters such as clarity, pH, and particulate matter. The FDA also requires that ophthalmic products be sterile and have appropriate uniformity of dose.
  • Nasal products: Nasal products should have specifications for parameters such as spray pattern, volume, and particle size. The FDA also requires that nasal products be sterile and have appropriate uniformity of dose.

It is important to note that these are just general requirements and that specific requirements for each dosage form can vary based on the intended use and the product’s formulation. Manufacturers should consult with the FDA for specific guidance on setting specifications for their products.

In conclusion, setting specifications and interpreting them according to current FDA guidance is critical for ensuring the quality and safety of pharmaceutical products. It is important for manufacturers to regularly review and update their specifications and to perform testing using validated methods in order to ensure that their products meet the expectations set by the FDA.


Upcoming Event

Oct 22


October 22-25, 2023 

Orlando, FL, USA

Orange County Convention Center

The Pathfinder

The latest in biotech for your ears

The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by an expert in the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment.

Subscribe to the Pathfinder

    Lets discuss your product