GMP: The Essentials

Adulteration, contamination and mislabeling of manufactured products can pose serious health risks to the public and cause costly product recalls. Beyond complying with regulations, following Good Manufacturing Practice (GMP) guidelines can minimize these risks, improve productivity and build confidence amongst your customers.

This article will provide a brief description and background of GMP and cover the basic guidelines promoted by the World Health Organization (WHO) and Food and Drug Administration (FDA) in complying with GMP. We also feature digital GMP self-inspection checklists you can use to prepare for inspections and remain compliant.

Related articles: Digital GMP Audit Checklists | 5S Lean | Gemba Walk

What is GMP?

Good Manufacturing Practice or GMP is a set of quality assurance practices promoted by regulatory authorities (including the WHO and US FDA) to ensure manufacturing processes are rigorously set and monitored. GMP guidelines help ensure that manufactured products like food, cosmetics, and pharmaceutical goods are guaranteed to be safe and of good quality. In addition, following GMP prevents risks of misbranding, contamination, or adulteration of manufactured goods.

GMP Regulators

In 1992, the WHO GMP was published as a guideline for manufacturing biological and pharmaceutical products. GMP is primarily used across 100 countries including Australia, Europe, China, the Philippines and Vietnam. Each country is responsible for the enforcement of GMP for their region.

In the United States, GMP is enforced by the US FDA through its Current Good Manufacturing Practices provisions (CGMP) and covers a broader range of industries such as cosmetics, food, medical devices, and prescription drugs. CGMP regulations contain minimum requirements for methods, facilities and controls used in manufacturing, processing, testing, and packaging of products. The FDA conducts facility inspections in the US to ensure compliance with CGMP. Serious violations can often lead to product recalls at the FDA’s request.

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10 Basic GMP Guidelines

GMP aims to diminish risks inherent in any manufacturing operation (e.g. cross contamination and mix-ups in pharmaceutical production), save money, and develop better manufacturing standards. Here are 10 Basic GMP Guidelines to follow:

  1. #1 Establish Good Written Procedures

    Establishing detailed written procedures can help workers perform their work more efficiently and in compliance with GMP. Standard procedures must be clearly defined and performed consistently.

  2. #2 Qualify and Validate Processes

    After following written procedures, validating the system in place and evaluating workers’ performance should be done next. It is at this stage that quality testing comes in.

  3. #3 Identify Roles and Responsibilities

    Creating a job description for each worker avoids misunderstandings and reduces the risk of negatively impacting product quality. With job descriptions laid out, everyone is aware of their tasks and issues like overlapping responsibilities can be avoided.

  4. #4 Keep All Records

    Keeping logs and records enable you to track all activities performed during manufacturing operations. The practice of record-keeping allows you to document problems, non-compliance, complaints, and other issues concerning processes.

  5. #5 Use the Right Facilities and Equipment

    The design and construction of facilities and equipment used should align with the company’s goal of achieving quality products and securing employee safety.

  6. #6 Assemble a Competent Team

    All workers must be trained to do the job right. Evaluate employee competencies and empower workers through proper training.

  7. #7 Practice Good Hygiene

    One practice of good hygiene is by cleaning the workplace on a daily basis. Use the 5S method or 6S lean to help identify hazards and eliminate risk of contamination.

  8. #8 Maintain Facilities and Equipment

    Regular facilities and equipment inspections are essential to determine if materials are properly maintained or need repair or replacement. Inspections also help control safety concerns and prevent accidents and injuries from occurring.

  9. #9 Ensure Quality

    Check the quality of materials before using them for production. Ensure that materials are approved and meet product specifications. Rejected items must be stored in a secure area.

  10. #10 Use GMP Audit Checklists

    GMP audit checklists can help companies comply with GMP guidelines set by regulatory authorities. By performing site visual walkthroughs and conducting manufacturing evaluations, you can identify non-compliant processes and take immediate action to rectify areas for improvement.

GMP is an efficient approach to improve both the manufacturing processes and the quality of products being made. Investing time and effort to comply with GMP also means you are investing in safety and the reduction of risks for your customers. Risks can be identified and workflows further developed with the aid of GMP audit checklists.

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GMP Checklists: Guide to Better Manufacturing Processes and Quality Products

iAuditor is the world’s #1 cloud-based inspection app used to convert paper forms to digital checklists. Sign up now and download these 100% free and customizable GMP checklists!

  1. General GMP Compliance Checklist
  2. FDA GMP Cosmetics Audit Checklist
  3. GMP Food Manufacturing Audit
  4. GMP Site Walkthrough Checklist

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