Specifications: Review, Writing, and Modernization

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Written Specifications

Inadequate specifications are among the most common compliance gaps observed in the supplement industry and are frequently cited as a top five violation on the FDA Form-483 (Inspectional Observations). Under Good Manufacturing Practice (GMP) regulations, specifications must include five required elements, and each must be utilized appropriately. 

We support the review, development, and modernization of specifications to ensure they are fit for purpose, aligned with regulatory expectations, and integrated into your quality system. This includes evaluation and implementation of specifications including the GMP Big 5: identity, purity, strength, composition, and limits for potential contaminants.

Specification development and maintenance are often a coordinated processes involving your suppliers, manufacturers, and laboratories. We help align these stakeholders. Not to mention your internal teams in quality, regulatory, purchasing and operations. 

This is a team effort! 

Verification of Specifications 

The natural progression from a good specification is the testing and monitoring plans. We like to work with your team to help align testing and monitoring programs to ensure products consistently meet established specifications using scientifically valid testing, appropriate sampling plans to represent the lot, and working with qualified laboratory partners. If you choose to use in house methods, we can help ensure they meet the regulation expectations including valid reference standards, qualified staff, and appropriate methods. 

Our approach focuses on building efficient and practical systems based on FDA inspection training and expectations from FDA Guidance, Compliance Programs, and Regulations. 

Do you need help? We have a service for specification review and optimization. 

Provide a fast, compliance-focused evaluation of existing specifications to identify:

• Regulatory gaps
• Verification Steps
•  Audit ready, proactive steps toward GMP compliance 

Based on FDA regulations:

• 111.70 - DS Specification Requirements
• 111.75 - Verification of Specification
• 117.126 - Food Safety Plans

Outcome: Delivering clear, prioritized recommendations. 

Program Structure and Workflow: NDA, document intake, review & assessment for compliance with the U.S.  FDA expectations, gaps identified, potential solutions & optimization steps described, and a debrief call. 

One Finished Product.

• One Finished Product Specification
• 3-5 Raw Material Specifications from within the Finished Product
• Associated Certificates of Analysis
• Hazard Analysis, if available
• Sampling and Testing SOP and Plan

Ingredient Specs for use in Dietary Supplements and Foods are also included in this style of review.

Estimated Time Commitment for a standard review: 8–15 hours, depending on documentation quality and organizational readiness. 

System Stabilization or Remediation Engagement: If major gaps are identified, additional time may be needed to implement full corrections. In this case, we will reassess priorities together as early as possible. This level of engagement may require 15-25 hours for reconstruction, rebuild, remediation, or to address significant gaps. 

These engagement scales are based on documentation maturity. 

This is a judgment-free advisory engagement. My role is to integrate with your team and provide objective, practical guidance as you move toward FDA compliance at a pace that works for your organization. We will meet your systems where they are and build forward, step by step. 

Next Steps: 

See below to set up an introduction call or get started immediately with the link at the bottom of the page ("Get Started. Book the Specification Readiness Assessment").