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cGMP Consulting Inc.
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  • New Product Introduction in Pharma | Project Management

    What Is NPI, Really? And Project Management’s Role in the Process

    May 6th, 2025Industry Expertise, NPI, Project Management, Trending News

    Explore how project management drives successful new product introduction in the pharmaceutical industry.

    Read More
  • Preclinical to Clinical: What It Really Takes

    The Preclinical to Clinical Transition: What It Really Takes

    April 28th, 2025Auditing, CQV, FUE, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development, Training, Trending News

    Explore what it takes to move from preclinical to clinical, with a focus on cGMP readiness and key challenges to be aware of for a successful transition.

    Read More
  • Pharmaceutical Still Equipment Qualification Example

    Real-World Example: Equipment Qualification of a Pharmaceutical Still

    April 21st, 2025CQV, FUE, Industry Expertise, Trending News

    Key questions to evaluate GMP certification readiness, spot gaps, and build a stronger quality system for FDA-regulated industries.

    Read More
  • GMP Certification

    GMP Certification: Is Your Manufacturing Facility Ready?

    April 15th, 2025Auditing, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions

    Key questions to evaluate GMP certification readiness, spot gaps, and build a stronger quality system for FDA-regulated industries.

    Read More
  • Trends and How They Impact Supplement Manufacturing

    Six Emerging Trends and Their Influence on Dietary Supplement Manufacturing Practices

    April 7th, 2025CQV, FUE, Industry Expertise

    Learn how six key trends are reshaping dietary supplement manufacturing and 21 CFR Part 111 compliance across the industry.

    Read More
  • Risk-Based Facilities, Utilities, and Equipment Qualification

    Facilities, Utilities, and Equipment Qualification: A Risk-Based Approach

    April 1st, 2025CQV, FUE, Industry Expertise

    Learn how a risk-based approach streamlines facilities, utilities, and equipment qualification for smarter, compliant pharmaceutical manufacturing.

    Read More
  • Controlled Room Temperature Qualification & Temperature Mapping

    Controlled Room Temperature Qualification and One Key Element: Temperature Mapping

    March 26th, 2025CQV, FUE, Industry Expertise

    Ensure compliance with controlled room temperature qualification and temperature mapping for warehouses, freezers, and incubators.

    Read More
  • Facility, Utility, and Equipment Qualification

    An Introduction to Facilities, Utilities and Equipment Qualification: Essential Steps for Compliance and Safety

    March 21st, 2025CQV, FUE, Industry Expertise

    Ensure compliance through proper facility, utility, and equipment qualification. Learn about IQ, OQ, PQ, and best practices for pharmaceutical manufacturing.

    Read More
  • Top FDA Observations in Dietary Supplement Manufacturing

    Top Two FDA Observations in Dietary Supplement Manufacturing: How to Avoid Them

    March 10th, 2025Auditing, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development, Training

    Learn the top FDA observations in dietary supplement manufacturing, how to avoid these compliance issues, and how cGMP Consulting can help you meet 21 CFR Part 111.

    Read More
  • Understanding 21 CFR Part 111 for Dietary Supplement Makers

    Understanding Dietary Supplement Regulations: 21 CFR Part 111

    March 4th, 2025GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Understand 21 CFR Part 111, the cGMP dietary supplement regulations for safe and compliant supplement manufacturing.

    Read More
  • Temperature Mapping

    Temperature Mapping: Protocol, Equipment, and Pro Tips

    February 21st, 2025CQV, Industry Expertise, Process Validation

    Learn about the process for ensuring controlled storage conditions, temperature mapping. Discover key equipment considerations. cGMP Consulting can help!

    Read More
  • Distributors: Why Temperature Mapping Is Essential for cGMP Compliance

    Why Temperature Mapping Validation Is Critical for Distributors

    February 18th, 2025CQV, Industry Expertise, Process Validation

    Learn why temperature mapping is vital for FDA-regulated distributors—ensuring compliance, product integrity, and risk protection.

    Read More
  • Why Distributors Should Embrace cGMP Compliance

    Unlocking Business Potential: Why Distributors Should Embrace cGMP Compliance

    February 11th, 2025GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development, Training

    Discover how cGMP compliance helps distributors access regulated industry opportunities by ensuring quality and building trust. Let cGMP Consulting help!

    Read More
  • Cross-Contamination Risk Assessment Template for GMP

    Cross-Contamination Risk Assessment for GMP Compliance

    February 4th, 2025CQV, Industry Expertise

    Discover how to create a cross-contamination risk assessment as a part of a Contamination Control Strategy to ensure compliance and safeguard product quality.

    Read More
  • Master Internal Audits for FDA Compliance in 2025

    Get FDA Ready: How Manufacturers Can Master Internal Audits in 2025

    January 21st, 2025Auditing, Industry Expertise, Quality & Regulatory Compliance Solutions

    Learn key steps to conduct effective internal audits, ensure FDA compliance, and boost operational efficiency in 2025. Stay ahead with expert tips.

    Read More
  • Industry 5.0 in cGMP: Revolutionizing Manufacturing Efficiency

    How Industry 5.0 is Revolutionizing cGMP: What Manufacturers Need to Know

    January 14th, 2025Industry News, cGMP, Industry Expertise

    Discover how Industry 5.0 revolutionizes cGMP by enhancing human-machine collaboration, improving efficiency, and ensuring compliance through advanced technology and innovation.

    Read More
  • GMP vs cGMP

    GMP vs cGMP: Understanding the Differences and Why They Matter in Modern Manufacturing

    December 13th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Explore GMP vs. cGMP, their key differences, principles, and benefits, and understand why staying 'current' is essential for regulatory compliance and manufacturing success.

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  • cGMP

    The Complete Guide to Current Good Manufacturing Practices (cGMP)

    December 6th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Learn the key differences between GMP and cGMP, why compliance matters, and how to implement cGMP for regulatory success. Stay competitive and compliant with this essential guide.

    Read More
  • FDA GMP Compliance

    FDA and GMP Compliance: What You Need to Know

    November 26th, 2024Auditing, Industry Expertise, Quality & Regulatory Compliance Solutions

    Get essential insights on FDA and GMP compliance to help your business meet regulatory standards effectively.

    Read More
  • GMP Good Manufacturing Practice

    A Comprehensive Guide to Good Manufacturing Practices (GMP)

    November 21st, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Quality Systems Development

    This guide covers the fundamentals of Good Manufacturing Practices (GMP), the 10 key elements for compliance, the GMP process, best practices, and FDA inspection insights.

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  • Resolving an FDA Warning Letter

    Success Story: Resolving an FDA Warning Letter for a Food & OTC Manufacturer

    November 18th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Regulatory Response

    Learn how a food and OTC manufacturer successfully resolved an FDA warning letter and improved their compliance practices.

    Read More
  • Cross-Contamination Risk Assessment in GMP

    Cross-Contamination Risk Assessment in GMP: Ensuring Safety and Quality

    November 12th, 2024CQV, Industry Expertise

    Learn how to assess and reduce cross-contamination risks in GMP to ensure product safety and quality compliance.

    Read More
  • FDA 483 Observations

    Avoiding Common FDA 483 Observations: An Industry-Specific Compliance Guide

    November 6th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Regulatory Response

    Discover practical strategies to avoid FDA 483 observations and ensure seamless compliance in your industry.

    Read More
  • Equipment Requalification Importance Equipment Qualification

    Why Equipment Requalification is Just as Important as Equipment Qualification for FDA Compliance

    October 31st, 2024CQV, FUE, Industry Expertise

    Learn why equipment requalification is essential for maintaining FDA compliance and operational efficiency.

    Read More
  • How to Qualify Sterile Fill Line Equipment: Key Steps and Best Practices for Compliance

    How to Qualify Sterile Fill Line Equipment: Key Steps and Best Practices for Compliance

    October 23rd, 2024CQV, FUE, Industry Expertise

    Learn the key steps and best practices to qualify sterile fill line equipment and ensure compliance.

    Read More
  • Driving Continuous Improvement in FDA-Regulated Industries: Strategies to Prevent FDA 483 Issues

    Driving Continuous Improvement in FDA-Regulated Industries: Strategies to Prevent FDA 483 Issues

    October 21st, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Regulatory Response

    Prevent FDA 483 issues with expert strategies in compliance, data integrity, and quality systems from cGMP Consulting.

    Read More
  • Proven Data Integrity Practices for CQV: Ensuring Compliance in Equipment Qualification

    Proven Data Integrity Practices for CQV: Ensuring Compliance in Equipment Qualification

    October 17th, 2024Commissioning, CQV, FUE, Industry Expertise

    Discover proven data integrity practices for CQV to maintain compliance in equipment qualification processes.

    Read More
  • Cost of FDA 483

    The True Cost of Receiving an FDA 483: A Breakdown of Financial and Operational Risks

    October 14th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Regulatory Response

    Understand the financial and operational risks of receiving an FDA 483 and how to prevent compliance issues.

    Read More
  • Equipment Qualification

    A Step-by-Step Guide to Equipment Qualification in a New Facility

    October 10th, 2024Commissioning, CQV, FUE, Industry Expertise

    Optimize your equipment for GMP compliance. Our guide covers qualification steps to ensure performance, reliability, and regulatory standards

    Read More
  • Immediate Steps to Take After Receiving an FDA 483: Don’t Risk a Warning Letter

    Immediate Steps to Take After Receiving an FDA 483: Don’t Risk a Warning Letter

    October 7th, 2024Industry Expertise, Quality & Regulatory Compliance Solutions, Regulatory Response

    Discover immediate actions to take after receiving an FDA 483 and prevent further compliance issues.

    Read More
  • Audit Readiness Training

    Your Complete Guide to Audit Readiness: The 5 Step Process

    October 2nd, 2024Auditing, Industry Expertise, Quality & Regulatory Compliance Solutions

    Prepare your organization for success with cGMP Consulting's Audit Readiness Training. Our 5-step process equips your team to excel in regulatory inspections.

    Read More
  • Commissioning, Qualification, and Validation (CQV)

    Understanding Commissioning, Qualification, and Validation (CQV): Ensuring Compliance in cGMP Environments

    October 1st, 2024Commissioning, CQV, Industry Expertise, Process Validation

    Learn about Commissioning, Qualification, and Validation (CQV) in cGMP environments to ensure compliance and product quality in the pharmaceutical industry.

    Read More
  • MoCRA GMP Compliance

    Immediate Steps for MoCRA GMP Compliance: What Cosmetic Manufacturers Can Start Today

    September 17th, 2024Industry Expertise, MoCRA, Quality & Regulatory Compliance Solutions

    Prepare for MoCRA GMP compliance with cGMP Consulting. Get expert help with assessments, SOPs, and training for early compliance and reduced risks.

    Read More
  • Seamless Implementation of Electronic GMP Systems

    Your How-to Guide: Seamless Implementation of Electronic GMP Systems

    August 27th, 2024Auditing, Industry Expertise, MoCRA, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Discover how to seamlessly implement electronic GMP systems with expert consulting from cGMP Consulting and amni.ai. Enhance compliance and operational efficiency in FDA-regulated industries.

    Read More
  • Cosmetic GMPs

    Your Guide to Cosmetic GMPs: The 10 Key Elements

    August 20th, 2024Industry Expertise, MoCRA, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Explore the essential elements of cosmetic GMPs and learn how cGMP Consulting can help ensure the safety, efficacy, and quality of your cosmetic products while navigating regulatory compliance.

    Read More
  • MoCRA compliance

    Your Guide to MoCRA Compliance: The 6 Key Elements

    August 8th, 2024Industry Expertise, MoCRA, Quality & Regulatory Compliance Solutions, Quality Systems Development

    Your essential guide to MoCRA compliance. Discover the latest regulations and steps to ensure your cosmetics meet FDA standards. Start preparing today!

    Read More
  • Mastering GMP Certification: Your Ultimate Guide to Compliance Success

    August 6th, 2024Auditing, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions

    Master the GMP certification process with cGMP Consulting’s ultimate guide. Learn about our comprehensive evaluation, certification recommendations, and ongoing compliance support.

    Read More
  • 8 Key Challenges in Obtaining & Maintaining GMP Certification

    8 Key Challenges in Obtaining & Maintaining GMP Certification

    August 5th, 2024Auditing, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions

    Facing challenges in GMP certification? Learn about the top obstacles and expert tips to achieve compliance in regulated industries.

    Read More
  • GMP Certification Audits

    New Service: GMP Certification Audits!

    June 24th, 2024Auditing, Company News, GMP Certification, Industry Expertise, Quality & Regulatory Compliance Solutions

    Elevate your quality standards with cGMP Consulting's GMP Certification Audits. ISO/IEC 17020:2012 accredited, we offer tailored audits for compliance and quality assurance.

    Read More
  • Assisted Line Clearance

    Assisted Line Clearance

    June 10th, 2024Cleaning Validation, Engineering Support, Industry Expertise, Project Engineering

    Discover the benefits and challenges of assisted line clearance in manufacturing. Learn how automation can enhance efficiency, quality, and compliance.

    Read More
  • Vaporized Hydrogen Peroxide Chambers

    Vaporized Hydrogen Peroxide Chambers

    June 4th, 2024Engineering Support, Industry Expertise, Project Engineering

    Explore the benefits of vaporized hydrogen peroxide chambers for sterilization in GMP environments. Essential insights for compliant manufacturing.

    Read More
  • Auditing Services

    A Guide to Mastering GMP Compliance: 8 Tailored Auditing Solutions from cGMP Consulting

    May 31st, 2024Auditing, Industry Expertise, Quality & Regulatory Compliance Solutions

    Master GMP compliance with cGMP Consulting's comprehensive auditing services. Explore 8 tailored solutions to enhance product quality, ensure regulatory adherence, and build market trust.

    Read More
  • Technical Writing: Deviations

    Technical Writing: Deviations

    May 28th, 2024CAPA Support, Industry Expertise, Operations Support, Technical Writing

    Learn best practices for managing deviations in technical writing to ensure compliance and maintain quality standards. Essential for regulated industries.

    Read More
  • Managing Deviations

    Managing Deviations

    May 20th, 2024CAPA Support, Industry Expertise, Operations Support, Technical Writing

    Discover effective strategies for managing deviations in regulated industries. Learn how cGMP Consulting can help improve compliance and operational efficiency.

    Read More
  • Cross Contamination Risk Assessments

    Cross Contamination Risk Assessments

    May 13th, 2024CQV, Industry Expertise

    Learn how cross contamination risk assessments can protect your products and ensure GMP compliance. Practical tips for every step.

    Read More
  • Risk Management in Regulated Industries

    Risk Management in Regulated Industries

    May 10th, 2024CQV, Industry Expertise

    Explore effective risk management strategies in regulated industries. Learn how cGMP Consulting can enhance your risk assessment processes for safety and compliance.

    Read More
  • Glove Testing

    Understanding Glove Testing in Drug Manufacturing

    November 15th, 2023CQV, Industry Expertise

    Ensure your gloves meet compliance standards. Explore essential glove testing procedures for GMP certification and safety in manufacturing.

    Read More
  • Cyber,Blue,Isometric,Neon,City,Virtual,Reality,Background.,Abstract,Technology

    Factory of The Future by Shivani Upadhyay

    October 25th, 2023Commissioning, CQV, FUE, Industry Expertise, Process Validation

    Explore the Factory of the Future with Shivani Upadhyay’s guide. Learn about digital technologies, agile processes, and modular tech to transform your manufacturing.

    Read More
  • Creating a Periodic Validation Review (PVR) Schedule

    Creating a Periodic Validation Review (PVR) Schedule

    July 12th, 2023CQV, Industry Expertise

    Learn how to create an effective Periodic Validation Review (PVR) Schedule for qualified equipment and systems

    Read More
  • Periodic Validation Review (PVR)

    Periodic Validation Review (PVR): Ensuring Ongoing Compliance

    July 5th, 2023CQV, FUE, Industry Expertise, Process Validation

    Discover what a Periodic Validation Review (PVR) is, how it's conducted, and how often it should be performed to ensure ongoing compliance and system control.

    Read More
  • cGMP Pharmaceutical Aggregation (Types)

    Pharmaceutical Aggregation: Securing the Supply Chain

    June 7th, 2023Industry Expertise

    Learn how pharmaceutical aggregation establishes traceability in the supply chain by linking serialized packaging.

    Read More
  • Temperature Mapping - Warehouse

    Temperature Mapping: Ensuring Optimal Storage Conditions

    May 31st, 2023CQV, Industry Expertise

    Temperature mapping is a Good Manufacturing Practice (GMP) utilized by a variety of industries to capture how temperature is distributed within a space.

    Read More
  • Clean Room

    A Comprehensive Guide to Cleanroom Basics

    April 13th, 2022Commissioning, CQV, FUE, Industry Expertise

    Cleanrooms are highly controlled spaces where pharmaceuticals are produced. Cleaning is the key element of contamination control.

    Read More
  • cleaning of pharmaceutical equipment

    cGMP Upgrade to Automated Cleaning

    March 2nd, 2022Cleaning Validation, CQV, Industry Expertise

    Automated cleaning in pharmaceuticals optimizes labor efficiency, ensures consistent results, and enhances safety through PLC monitoring.

    Read More

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cGMP Consulting Inc.

cGMP Consulting has helped clients stay compliant with the current Good Manufacturing Practices (cGMP) and implement new technologies since 2001.

We are ISO accredited and perform GMP Certification Audits.
cGMP Consulting Inc.

580 N Bank Lane

Lake Forest, IL 60045

Phone:1 (312) 420-7682

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