Becoming cGMP (Current Good Manufacturing Practices) compliant is a commitment and can be a demanding process, especially for small businesses and those subject to new regulations. cGMP certification is yet another level of compliance and is not a one-time achievement but an ongoing obligation. Manufacturers must continuously monitor and improve their processes to maintain conformity with cGMP standards. Here are some common challenges companies might face. See the PDF below for more details. By being aware of these challenges and proactively addressing them, companies can better sustain their cGMP certification and ensure ongoing compliance. #cGMP #cGMPCertification #QualityAssurance #Compliance
cGMP Consulting Inc.
Pharmaceutical Manufacturing
Lake Forest, Illinois 2,710 followers
Established engineering and regulatory compliance firm providing comprehensive services to FDA regulated industries
About us
Founded in 2001, cGMP Consulting Inc. assists clients in adopting new technologies and ensuring compliance with current Good Manufacturing Practices (cGMP). Our seasoned engineering and quality assurance consultants have effectively supported numerous leading companies regulated by Title 21 of the CFR. We excel in identifying and addressing gaps, supporting international pharmaceutical manufacturing, and implementing cGMP requirements.
- Website
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http://www.cgmpconsulting.com/
External link for cGMP Consulting Inc.
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Lake Forest, Illinois
- Type
- Privately Held
- Founded
- 2001
- Specialties
- Equipment Qualification, Validation Master Plans, Process Validation, Pharmaceuticals, Project Management, Track and Trace Serialization, Engineering, Quality Systems Development, Cosmetics, Dietary Supplements, FDA Regulatory Compliance, MoCRA, Cleaning Validation, Auditing, Facilities Qualification, Utilities Qualification, Computer System Qualification, Standard Operating Procedures, 483 Remediation, and Warning Letter Remediation
Locations
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Primary
580 N Bank Ln
Lake Forest, Illinois 60045, US
Employees at cGMP Consulting Inc.
Updates
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We're here to be your MoCRA compliance partner and with that, we’d like to share the FDA’s announcement of the availability of two new features in Cosmetics Direct, the electronic submission portal: • Discontinuation Notices: Easily manage product lifecycle changes. • Relisting Options: Swiftly reintroduce discontinued products. Like and follow us to stay compliant and ahead of the curve with the latest updates and services. Read more here: https://lnkd.in/gvhi2hYW #CosmeticsIndustry #FDA #MoCRA #Compliance #Innovation #CosmeticsDirect
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Here’s your guide to becoming cGMP Certified! Yesterday, we assessed your readiness for cGMP Certification. Today, we are pleased to share our cGMP Certification Audit flyer, designed to guide you through the essential steps to achieve cGMP certification, ensuring a smooth and successful certification journey. Download the Flyer Today! https://lnkd.in/gG55ASGW. Discover how our cGMP Certification Audit services can benefit your business and prepare you for the path to compliance and success. #cGMP #QualityManagement #RegulatoryCompliance #BusinessGrowth #cGMPConsulting #CertificationAudit #ComplianceReady
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Is Your Company Ready for cGMP Certification? Find Out Now! We understand that our clients may be unsure if they are ready for cGMP certification. That's why we've created a comprehensive response to this frequently asked question. Check out our FAQ page at https://lnkd.in/gGH-739j to discover the key requirements. With years of experience in quality system development and regulatory compliance, our team at cGMP Consulting is here to support you through this important audit process, the first step being an assessment for readiness. Ready to take the next step? Visit our website to access the FAQ and learn more about our cGMP Certification Audit services. We are committed to helping you achieve your compliance goals and drive your business growth. #cGMP #QualityManagement #RegulatoryCompliance #BusinessGrowth #cGMPConsulting #cGMPCertificationAudit #ComplianceReady
Explore FAQs: Your Guide to cGMP Consulting's Services
https://cgmpconsulting.com
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We're excited about the launch of our new service: cGMP Certification Audits! Leading this service is Luis Nieves, our esteemed Senior Quality Systems Auditor with over 38 years of extensive experience in quality assurance and compliance. Luis is a cornerstone of our team, consistently ensuring our clients meet the highest standards of current Good Manufacturing Practices. His unparalleled expertise and dedication make him the perfect fit to lead our cGMP Certification Audits. Fluent in English and Spanish, he provides comprehensive support tailored to diverse organizational needs. Visit our website to learn more Luis and our cGMP Certification Audits. https://lnkd.in/gm5TSY2F #cGMPConsulting #cGMPCertificationAudit #QualityAssurance #ManufacturingExcellence #MeetOurTeam
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On June 26, our Pfanstiehl dedicated cGMP Consulting team enjoyed a fun lunch from Big Ed's BBQ in Waukegan, Illinois. It was a delicious way to relax, chat, and strengthen our team spirit. We’re extremely proud of the accomplishments we’ve made over the years with this important, long standing client. What a great opportunity to celebrate! https://lnkd.in/gVSkRThY #TeamBonding #cGMP #Pfanstiehl #BBQFun
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Is your organization cGMP compliant? Or is your goal to become cGMP compliant and eventually cGMP Certified? With the launch of our new cGMP Certification Audit Service, we’re here to help. Check out our general checklist below. By partnering with us, you'll gain access to: ✅ Expert auditors with deep industry knowledge ✅ Comprehensive audit with actionable insights ✅ Customized solutions to enhance your cGMP compliance Ready to elevate your cGMP compliance? Contact us today to schedule your certification audit and ensure your operations meet the stringent requirements of cGMP standards. https://lnkd.in/gm5TSY2F #cGMP #Compliance #cGMPCertificationAudit #QualityManagement #cGMPConsulting #RegulatoryCompliance
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We had a fantastic time at our cGMP Summer Picnic! It was a day filled with delicious food, fun games like cornhole and spike ball, and celebrating our team's achievements and milestones. A big thank you to everyone who joined us for making it such a memorable day! https://lnkd.in/gusFxQgf #SummerPicnic #TeamBuilding #CompanyCulture #cGMPConsulting #EmployeeRecognition
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Wishing everyone a joyful, fun, firework-filled, and safe Fourth of July! #happy4th #GMP #independenceday
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