Are you responsible for Good Manufacturing Practices (GMP) auditing and quality control in your company? Then you know how important it is to have the right tools. Software can be a huge help in managing these processes more efficiently. In this blog post, we will discuss how the GoAudits mobile app and digital checklists can help streamline GMP audits and quality assurance, and provide free templates for your GMP audits and self-inspections.
What is GMP (Good Manufacturing Practice)?
GMP or Good Manufacturing Practice is a set of guidelines that manufacturers must follow to guarantee that manufactured products are safe for human consumption or use. Many countries have established GMP rules and guidelines that match their legislation, in order to protect the general public from harm.
The GMP guidelines most commonly apply to food and beverage, cosmetics, pharmaceutical products, dietary supplements, and medical device industries. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff:
- People: roles and responsibilities, appropriate training
- Products: thorough testing from starting materials to packaging
- Processes: defined and controlled manufacturing steps that ensure consistency
- Procedures: detailed Standard Operating Procedures, good documentation, regular checks and batch records
- Premises: cleanliness, hygiene standards, correct equipment, eliminating cross-contamination or accident risks
GMP standards are not prescriptive. It’s a set of performance-based requirements, for which each manufacturer sets up their own quality control processes. This means creating detailed written procedures for the manufacturing process, essential for each process that could affect the quality of raw materials or the finished product.
Enforcement of GMP standards is ensured by specialized agencies such as the Food and Drugs Administration in the US, the European Medicines Agency, and other national agencies.
The 10 principles of GMP (and how GMP software can help)
GMP guidelines can be summarized into 10 principles, and software can help you achieve regulatory compliance in each of these steps.
1. Creation and Implementation of SOPs
Every process potentially impacting product quality must have detailed, written procedures. For example, Standard Operating Procedures (SOPs) establish consistent operational guidelines. They act as a comprehensive ‘instruction manual’ for daily operations, ensuring that every process is performed uniformly. Utilizing software ensures these guidelines are always current, easily accessible, and adhered to.
2. Design and Maintenance of Facilities and Equipment
Facilities and equipment should be designed, maintained, and cleaned to safeguard product quality. Regular validation and calibration of equipment are vital to ensure consistent and reliable operations. This requires regular inspections for cleaning and housekeeping standards, as well as equipment checks and equipment cleaning, which can be made easier with an inspection app.
3. Quality Assurance in materials
All materials used in the manufacturing process, including ingredients and packaging, must be of tested quality, clearly identified, and traceable. This ensures the integrity and safety of the final product.
4. Controlled and Validated Production Processes
Manufacturing processes need to be clearly defined, controlled, and validated. Quality assurance needs to be embedded in the production process to guarantee consistent quality in every step, every day. Validation of critical processes is essential.
5. Rigorous Quality Control
Quality control is paramount, involving testing products at various production stages. These tests ensure the identity, purity, potency, and overall quality of the product, adhering to stringent standards. Digitizing quality checks with an inspection app makes it easier to embed QA in daily operations.
6. Comprehensive Documentation
Accurate and comprehensive documentation, including records and raw data related to production and distribution, is essential. These documents must be retained for review, showcasing transparency and traceability. The GMP software can streamline this process, ensuring secure and organized record-keeping.
7. Trained and Qualified Personnel
The role of qualified, trained personnel in quality processes cannot be overstated. Each individual involved in the manufacturing process must possess the necessary education, training, and experience to perform their tasks effectively. A checklist app gives access to SOPs and easy checklists on a mobile device, making it easier to train staff.
8. Validation and Control of Changes
Any changes to the manufacturing process must undergo thorough review, validation, and documentation. This ensures that the quality of the product remains uncompromised by any modifications.
9. Handling of Complaints and Recalls
Effective systems for managing complaints and product recalls are crucial. This involves the investigation and review of complaints and implementing appropriate corrective actions, ensuring ongoing product safety and quality. Software helps keep track of corrective actions, ensuring accountability and traceability.
10. Regular Auditing for Compliance
Conducting regular audits is key to ensuring adherence to GMP guidelines. These audits help identify areas for improvement and ensure the implementation of corrective actions, maintaining the highest standards of quality. Audit management software can streamline the planning, execution, and documentation of these audits.
Incorporating these principles ensures that a manufacturing facility operates at the highest standards, producing safe and quality products. Each principle focuses on a specific aspect of manufacturing, working together to create a comprehensive framework for quality and safety.
Best practices of GMP audits and operational checks
GMP compliance not only improves the reputation of manufacturing firms but also cuts batch recalls and negative feedback from customers. A GMP software can help with each and every one of the GMP principles outlined above. However, more particularly, the software can help streamline GMP audits, self-inspections, and daily production line checks.
A GMP audit is a process by which a quality assurance specialist or auditor reviews the procedures and operations of a manufacturing facility to ensure that they meet the GMP guidelines. The purpose of the GMP audit is to identify any areas in which the manufacturer needs to improve their compliance with the guidelines.
Frequency of GMP self-inspections
The GDP guidelines do not specify how often self-inspections should be carried out. However, the following aspects should be taken into consideration:
- Self-inspections should be planned and carried out according to a schedule
- A risk-based approach should be used to determine what areas to cover with what frequency.
- Self-inspections should be at least annual.
At the operational level, GMP audits may include annual evaluations of the whole quality management system, but they are also made up of on-the-job daily inspections by the Quality team embedded in the production line. Additionally, all staff have to be trained and aware of GMP requirements, for example via manufacturing SOPs or written instructions.
Quality checks on the production line
Ensuring GMP compliance can therefore imply frequent checks. As a result, training the whole team on the production floor can quickly become an administrative burden. Paper-based audit checklists or spreadsheets can get easily lost and can be tricky to retrieve when needed. With data scattered in different sources, is also hard to see an overview or historical trends.
Digitize your GMP self-inspections with a simple GMP compliance software
In order to streamline GMP audits and quality control, many businesses are turning to GoAudits, a mobile app that allows users to create digital checklists and easily collect data from the production line.
Nissin Foods, the manufacturer of Cup Noodles, implemented the GoAudits inspection app to manage quality control, product and packaging integrity checks, facility inspections, standard operating procedures, and more. The app is very easy to use for production staff and the audit completion rates significantly improved after the introduction of the app.
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, the Quality Control Manager, Nissin Foods
When it comes to choosing software for your GMP audits and quality control, there are a few important features to look for. Here is a checklist of what to look for:
- The ability to easily create and manage customized checklists.
- Automated reporting features to accelerate the resolution of non-compliance
- Task management and workflows to assign corrective actions in case of non-conformance
- User-friendly and simple interface to maximize adoption
- Summary reports and dashboards that allow to uncovering of additional insights and improve processes
Free GMP audit checklists and templates
To help you digitize your quality assurance processes, GoAudits offers a library of GMP and other manufacturing audit checklist templates to get started quickly. Our customer support service can also help digitise your existing checklists during your 14-day free trial. Here are some examples that will help you visualize the use of such digital checklists:
- GMP Internal Audit checklist
- GMP inspection checklist
- GMP checklist for breweries
- Food Manufacturing SOP checklist
- Food Manufacturing Hygiene Checklist
- Vendor quality audit checklist
- BRC audit checklists
- HACCP Plan checklist
- SQFI Food Manufacturing audit checklist
- More manufacturing audit checklists
- More food production audit checklists
Learn more about GoAudits functionalities: GoAudits for Manufacturing.