cGMP Consulting Inc.

New manufacturing facilities or spaces require facilities, utilities, and equipment be qualified for regulatory compliance, product quality, and patient safety.?? ? Our latest article, "An Introduction to Facilities, Utilities, and Equipment Qualification: Essential Steps for Compliance and Safety", breaks down key concepts like Qualification vs Validation, IQ, OQ, PG, and best practices for qualification of your facility and its utilities and equipment.? ? Read the full article here: https://lnkd.in/gadpf7RU ? Have you faced challenges in qualification processes? Share your experiences and insights in the comments!?? ? #PharmaceuticalManufacturing #cGMP #QualificationAndValidation #EquipmentQualification #IQOQPQ #Compliance #GMP #FacilitiesUtilitiesAndEquipmentQualification?

Spring into Compliance! The first day of spring is here—a season of growth, renewal, and fresh starts! Just as nature transitions, our businesses must also adapt and evolve to maintain compliance and efficiency. As the seasons change, now is the perfect time to:? ?? Reevaluate qualification needs for facilities, utilities, and equipment.? ?? Prepare for seasonal qualifications (e.g., summer and winter mapping for temperature-controlled storage).? ?? Refresh risk assessments to ensure ongoing regulatory compliance.? ?? Optimize validation processes for new and existing equipment. How is your team preparing for the season ahead? Let’s discuss! #SpringIntoCompliance #GMP #QualificationAndValidation #EquipmentQualification #IQOQPQ #RegulatoryCompliance??

cGMP Consulting celebrated Employee Appreciation Day at Crust Brewing! It was a great opportunity for team members from different client sites to connect and enjoy a well-deserved break. We’re grateful for the hard work and dedication of our incredible team. #TeamAppreciation #HappyHour #Networking #EmployeeEngagement

Celebrating St. Patrick’s Day with a Commitment to Quality In Chicagoland, we celebrate St. Patrick’s Day with enthusiasm—but when it comes to quality and compliance, luck is never a strategy. Success is built on expertise, preparation, and continuous improvement. At cGMP Consulting, we help companies move beyond luck to ensure long-term compliance and operational excellence. Wishing you a safe and happy St. Patrick’s Day! #StPatricksDay #QualityExcellence #cGMPConsulting??

Ensuring dietary supplement quality goes beyond just ingredient lists. Identity, Purity, Strength, and Composition are key pillars in regulatory compliance and consumer safety: ?? Identity – Verifying raw materials to prevent adulteration.? ??Purity – Confirming the absence of contaminants and impurities.? ??Strength – Ensuring active ingredients meet labeled potency.? ??Composition – Maintaining correct formulation consistency. Robust testing of both raw materials and finished products is essential for regulatory compliance, product efficacy, and consumer trust. ? How is your organization addressing these compliance challenges? Let’s discuss! #DietarySupplements #FDACompliance #GMP #QualityControl #IdentityTesting #ProductTesting #RegulatoryCompliance?

The FDA’s focus on 21 CFR Part 111 compliance is increasing, with product specifications and ingredient identity specifications being top violations in 2023 and 2024. Our latest article breaks down these two most common FDA observations and provides actionable steps to stay compliant and inspection-ready. Read more: https://lnkd.in/guRCcRxF #cGMP #21CFRPart111 #FDACompliance #DietarySupplements #QualityAssurance

Today, we’re highlighting the two most common FDA observations for dietary supplement manufacturers over the past two years. ?? 21 CFR 111.70(e) remains the most frequently cited issue, with 78 observations in 2023 and 91 in 2024—primarily for failure to establish an identity specification for each component.? ?? 21 CFR 111.70(b)(1) has emerged as a rising concern, with zero observations in 2023 but 66 in 2024—a clear indication that FDA has made this a new enforcement priority. At cGMP Consulting Inc., we’ve worked with numerous dietary supplement manufacturers to address 21 CFR Part 111 compliance challenges. Stay tuned—tomorrow we’ll publish an article exploring these observations in more detail, along with practical, actionable strategies to help manufacturers stay ahead of compliance risks. #DietarySupplements #FDACompliance #cGMP #RegulatoryReadiness #QualityMatters #cGMPConsulting?

Join Our Team at cGMP Consulting! cGMP Consulting Inc. is growing, and we’re looking for top talent! We’re hiring for the following roles: ?? Electrical Engineer SME ??DeltaV Project Manager Explore career opportunities & apply today: https://lnkd.in/ePVKym5b #Hiring #EngineeringJobs #ElectricalEngineering #SME #DeltaV #ProjectManagement #GMP #CareerOpportunities

Announcing Our New Facilities, Utilities, and Equipment (FUE) Qualification Page!? For decades, we’ve been providing gold-standard Facilities, Utilities, and Equipment (FUE) Qualification services, achieving industry-leading expertise after years of working with top pharmaceutical companies. While FUE Qualification is not new to us, our website now better reflects the depth of expertise and industry leadership we bring. What you’ll find:? ? Our gold-standard FUE service and how it ensures compliance, process efficiency, and product quality.? ? A breakdown of our process, giving you insight into what to expect when working with cGMP Consulting.? ? IQ, OQ, PQ explained—critical steps for meeting cGMP standards.? ? Qualification vs. Validation—understanding the key differences in these terms, often used interchangeably.? ? Resources and expertise to help you navigate the qualification process with confidence. Check it out here: https://lnkd.in/gTSYNsxj? ? #FacilitiesUtilitiesAndEquipmentQualification #IQOQPQ #EquipmentQualification #QualificationAndValidation #cGMPCompliance #GMP #RegulatoryCompliance #PharmaceuticalManufacturing?

Celebrating International Women’s Day – March 8th As we approach International Women’s Day, we want to take a moment to recognize the incredible women who continue to shape our company, our industry, and our world. We encourage everyone to take time to reflect on the impact of women in their lives, workplaces, and communities—and to continue fostering a culture that values and supports all individuals. #InternationalWomensDay #IWD2025 #cGMPConsulting?