Applicable to manufacturing businesses, particularly food & beverage, pharmaceuticals, and cosmetics, GMP audits evaluate whether their manufacturing processes comply with quality standards. Whether conducted internally or by external auditors, GMP compliance audits guarantee consistent production and control of products to ensure their safe use. It helps manufacturing businesses, regulated by authorities like the FDA, identify areas for improvement and maintain compliance.
This blog will dive into the five pillars of GMP audits, their benefits, best practices, and how GoAudits can help you prepare for a typical GMP audit, and free customizable checklists to streamline the GMP internal audit processes.
Table of ContentsYes, GMP audits are mandatory for industries regulated by health authorities such as the FDA. Failure to comply with GMP can lead to significant consequences, including product recalls, fines, and damage to reputation.
The duration of a GMP audit can vary significantly depending on the scope of the audit, the size of the facility being audited, and the specific requirements of the regulatory authority or the auditing body. It might take from a few days to several weeks.
As for frequency, it’s common practice to conduct comprehensive GMP internal audits annually. However, this can vary based on regulatory requirements, the complexity of operations, and previous audit findings. External or third-party audits might occur less frequently, often every two to three years, or as dictated by certification or regulatory bodies.
Either way, it’s highly advisable to conduct smaller-scale frequent internal checks to ensure GMP compliance in daily operations.
The GMP audit process encompasses several critical areas, including:
The 5 Ps are the pillars of GMP audits. Here’s a detailed look into each of the 5 Ps of GMP audits:
Workers must be adequately trained for their roles, adhere to hygienic practices, and use appropriate protective equipment to prevent contamination. This includes wearing hair nets, gloves, and other protective gear, and ensuring facilities for hand washing and sanitary practices are accessible.
This involves proper maintenance of the grounds, buildings, and facilities to ensure a clean, organized environment that minimizes the risk of contamination. Key aspects include waste management, adequate lighting, and proper ventilation systems to support sanitary operations and prevent product contamination.
This includes having written specifications and work instructions that are readily available to employees to ensure compliance with safety and quality standards, such as HACCP (Hazard Analysis Critical Control Point) and other food safety standards.
👉 Additional Resources: Learn how HACCP software & checklists can streamline HACCP audits
This includes rigorous control over production, labeling, handling, and storage practices to ensure that products are consistently produced and remain safe for consumption.
Standard operating procedures (SOPs) should clearly define operational processes, and records should be meticulously maintained to document compliance with these procedures. This includes keeping track of changes, customer complaints, laboratory test results, and other relevant information.
Learn More: The 10 Basic GMP Principles
Let’s dive into the nine parts of a GMP audit, highlighting their significance and how they contribute to maintaining high-quality standards.
1. Personnel
The focus here is on ensuring that employees are healthy, appropriately dressed, and follow strict hygiene and food handling protocols. Training and supervision policies are also reviewed to ensure everyone is competent in their roles and understands the importance of GMP standards.
2. Plant and Grounds
It involves evaluating the cleanliness and maintenance of the facility’s exterior, including waste management and the prevention of pest infestation. The aim is to ensure the surrounding environment does not pose a risk to the cleanliness or safety of the products.
3. Sanitary Operations
Auditors assess the cleanliness and maintenance of facilities and equipment. This includes reviewing the procedures for cleaning, the storage of toxic substances, and the effectiveness of pest control measures.
4. Sanitary Facilities and Controls
This examines the availability and condition of sanitary facilities such as potable water, plumbing, and waste disposal systems. The goal is to prevent any possibility of contamination.
5. Equipment and Utensils
The GMP audit checks whether equipment and utensils are maintained and cleaned to prevent contamination. It also reviews the materials from which equipment is made to ensure they are non-toxic and corrosion-resistant.
6. Processes and Controls
It reviews the control measures for preventing contamination during the production process, including the handling of raw materials, cross-contamination risks, and packaging procedures.
7. Warehousing and Distribution
Auditors look at how products are stored and transported to ensure that they are handled correctly and that conditions during storage and transport do not compromise the product’s quality.
8. Holding and Distribution of Human Food By-Products for Use as Animal Food
This ensures that by-products intended for animal food are stored and handled in a way that prevents contamination and distinguishes them from waste materials.
9. Defect Action Levels
The focus is on the procedures in place to address and correct product defects immediately. This is critical for preventing contaminated or substandard products from reaching consumers.
👉 Useful Resource: Food Safety & Quality Audit Checklists
Explore our extensive library of restaurant checklists. Sign up for free and easily customize these checklists to get started.
Preparing for GMP audits can be challenging due to the complexity of the guidelines that must be followed. However, digital tools like GoAudits can make the process more efficient.
GoAudits helps businesses to streamline audits and inspections. Let’s find out how to prepare for a typical GMP audit, focusing on initial preparation, document management, developing SOPs, conducting internal audits, and implementing continuous improvement strategies.
Begin your GMP audit preparation by reviewing past audit results and FDA inspections to identify areas of improvement. This review should cover all operations, including those outsourced. Set up a specific GMP audit agenda with timelines and necessary personnel, ensuring your team understands their roles and responsibilities. Preparation also involves ensuring that all contracts and documentation are ready and easily accessible.
Having a digital audit trail facilitates easy access to historical audits, allowing you to analyze previous findings and corrective actions.
Ensure all documents subject to GMP audits are organized and easily accessible. This includes manufacturing procedures, quality control reports, and team member training manuals.
With GoAudits, all your essential documents can be digitized and stored securely in the cloud, making them easily accessible from any device, anytime, anywhere. This not only saves time during the audit by avoiding the search for physical documents but also ensures that the latest versions of all documents are readily available.
Develop SOPs with a clear audit agenda. It should cover the GMP audit’s scope, including physical locations, organization units, actions, and processes. The agenda should also outline the expected timelines, roles, and responsibilities of audit team members, and be communicated clearly to all involved. With GoAudits, you can create and update SOPs directly within the platform.
GMP internal audits allow you to assess your compliance with GMP standards before the external audit. It should cover facilities, equipment, and personnel training, identifying non-conformances and areas for improvement. It helps in gathering the necessary information and familiarizing the team with the audit process, ensuring a smoother external audit.
GoAudits simplifies the internal audit process with customizable audit checklists, real-time data collection, and instant report generation. It allows you to identify non-conformances and areas for improvement efficiently. It can also help identify trends and recurring issues, facilitating targeted improvements and ensuring readiness for the GMP compliance audit.
It’s easy to get started with GoAudits! Sign up for a free 14-day trial (we even digitize your checklists for free!). Or even better: Book a personalized demo with one of our experts!
After identifying non-conformances, create a corrective action request (CAR) to document and assign responsibility for each issue. Following up on these actions to ensure they are completed effectively is crucial for maintaining compliance and improving processes. Regular updates and the impact of corrective actions should be monitored and documented to demonstrate commitment to GMP compliance and continuous improvement.
After identifying areas for improvement, GoAudits lets you assign corrective actions, set deadlines, and monitor progress in real-time. It ensures that all corrective actions are documented, followed up on, and completed within the specified timeline.
👉 Success Story: Nissin Foods USA
Nissin Foods, renowned for inventing Cup Noodles, completely transformed its GMP audits by adopting GoAudits to digitize quality checks. From paper-based to digital inspections, they achieved enhanced operational efficiency, real-time data access, and quicker corrective actions.
“We are now averaging over 96% completion ratios for our GMP audits. With the ability to immediately email the report to the relevant parties, we get real-time information that allows our supervisors to sign-off corrective actions and resolve any issues much quicker than before.”
Eddie Odie, Quality Control Manager, Nissin Foods USA
Addressing the industry’s audit challenges, the GoAudits manufacturing inspection software offers a rich collection of checklists for manufacturing, GMP audits, and food safety to streamline the auditing processes.
You can use one of our GMP audit checklists below to get started, create your own checklist, or you can let us do it for you at no cost.
👉 More Useful Resources:
Check out more manufacturing audit checklists and food & hospitality audit checklists that you can customize to manage standards within your organization.
Here are the major benefits of GMP compliance audits:
GMP audits help businesses ensure that their operations comply with regulatory requirements, reducing the risk of legal issues and fines. This is particularly essential in pharmaceuticals, where non-compliance can lead to severe repercussions, including product recalls or legal actions.
By identifying areas for improvement in processes, equipment, and personnel practices, GMP compliance audits ensure better product quality. It also helps in maintaining consistency in product production that meets safety and efficacy standards.
GMP manufacturing audits can pinpoint inefficiencies and areas for cost savings, making manufacturing processes more efficient and reducing wastage.
GMP audits raise awareness among employees about compliance and quality issues, ensuring that they are well-informed about the standards and regulations. This can also lead to a more committed workforce that understands the impact of their work on product quality and compliance.
Compliance with GMP standards through regular GMP audits can enhance customer trust and confidence. Customers are more likely to choose products from companies that are known for their compliance and high-quality standards.
CGMP stands for Current Good Manufacturing Practice. CGMP audits play a crucial role in the pharmaceutical industry, acting as a rigorous assessment mechanism to ensure that manufacturing facilities comply with the Current Good Manufacturing Practices enforced by regulatory authorities like the FDA. CGMP audits evaluate the entire manufacturing process, from raw material sourcing to the final product, to mitigate risks of contamination, errors, and substandard products, ultimately safeguarding patient safety and ensuring product consistency.
While both GMP and cGMP are regulations that outline the standards for manufacturing practices, the ‘c’ in CGMP stands for ‘current,’ highlighting the necessity for manufacturers to use the latest technologies and systems to ensure product quality and safety. The CGMP regulations are inherently designed to be flexible, allowing companies to tailor the implementation of these controls using scientifically sound design, processing methods, and testing procedures.
CGMP audits not only assess compliance but also focus on the culture of quality within manufacturing facilities. They are comprehensive, covering everything from the initial design and monitoring of manufacturing processes to the controls in place for ensuring product consistency and quality. CGMP audits are integral to establishing a formal system of controls at pharmaceutical companies, which, if adequately implemented, helps prevent contamination, mix-ups, deviations, failures, and errors, ensuring that drug products meet their quality standards.
Using a digital tool like GoAudits can enhance the efficiency and effectiveness of your GMP audit preparation. It allows for better documentation management, facilitates easier access to records, and streamlines the process of conducting GMP internal audits and managing corrective actions. Its ability to work across devices—even offline—ensures that your team can capture every detail promptly, making the audit process up to five times faster.
