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News filtered by category

  • Validation Engineering | GMP Compliance – cGMP Consulting

    From Documentation to Execution: What Validation Engineers Deliver at cGMP Consulting

    July 2nd, 2025Engineering Support, FUE, Industry Expertise

    Discover how cGMP Consulting’s validation engineers support GMP compliance through documentation, coordination, execution, and audit-ready processes.

    Read More
  • Preclinical to Clinical: What It Really Takes

    The Preclinical to Clinical Transition: What It Really Takes

    April 28th, 2025Auditing, FUE, Industry Expertise, QMS, Training

    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, 2025FUE, Industry Expertise

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

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

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

    April 1st, 2025FUE, 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, 2025FUE, 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, 2025FUE, Industry Expertise

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

    Read More
  • Temperature Mapping

    Temperature Mapping: Protocol, Equipment, and Pro Tips

    February 21st, 2025FUE, Industry Expertise

    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, 2025FUE, Industry Expertise

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

    Read More
  • Cross-Contamination Risk Assessment Template for GMP

    Cross-Contamination Risk Assessment for GMP Compliance

    February 4th, 2025CQV, Engineering Support, Industry Expertise, Quality & Regulatory Compliance Solutions

    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
  • Cross-Contamination Risk Assessment in GMP

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

    November 12th, 2024CQV, Engineering Support, Industry Expertise, Quality & Regulatory Compliance Solutions

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

    Read More
  • Equipment Requalification Importance Equipment Qualification

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

    October 31st, 2024FUE, 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, 2024FUE, Industry Expertise

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

    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, 2024CQV, Industry Expertise

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

    Read More
  • Equipment Qualification

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

    October 10th, 2024FUE, Industry Expertise

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

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

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

    October 1st, 2024CQV, Industry Expertise

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

    Read More
  • Vaporized Hydrogen Peroxide Chambers

    Vaporized Hydrogen Peroxide Chambers

    June 4th, 2024CQV, Industry Expertise

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

    Read More
  • Cross Contamination Risk Assessments

    Cross Contamination Risk Assessments

    May 13th, 2024CQV, Engineering Support, Industry Expertise, Quality & Regulatory Compliance Solutions

    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
  • Factory of the Future

    Embracing the Factory of the Future

    October 25th, 2023CQV, Industry Expertise

    Discover how to build intelligent factories with digital technologies, agile processes, and modular systems. Improve efficiency, sustainability, and adaptability in modern 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, Industry Expertise

    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
  • Temperature Mapping - Warehouse

    Temperature Mapping: Ensuring Optimal Storage Conditions

    May 31st, 2023FUE, 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, 2022FUE, 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, 2022CQV, Industry Expertise

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

    Read More

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Logo 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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