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GMP (Good Manufacturing Practice)

Strengthen your GMP in the company by understanding the 12 basic guidelines and maximizing today's technologies.

What is GMP?

Good Manufacturing Practice (GMP) is the testing of manufacturing products such as food, cosmetics and pharmaceutical products with the help of defined quality standards. GMP supports the avoidance of cross-contamination, adulteration and mislabelling, which can reduce loss and waste and thus provide consumers with optimum protection.

In this article the following questions are discussed:

1. Why is GMP important?

2. What is a GMP certification? The most important principles

3. What is GMP compliant documentation? 4 Tips for GMP compliance

4. How do digital technologies support GMP documentation?

5. Summary

Why is GMP important?

The quality of manufactured products is strictly regulated, as it may pose negative health risks to consumers or the environment. Win manufactured products that do not comply with GMP guidelines can have fatal consequences for consumers, such as: poor hygiene and inadequate temperature controls, cross-contamination and adulteration.

GMP is a globally recognized system for process evaluation. A company that wants to ensure good manufacturing practice must first implement a basic system for effective evaluation and documentation. Only accurate and complete documentation can guarantee the safety of the manufactured products.

What is GMP certified? The most important principles

The GMP guidelines for obtaining GMP certification contain a number of basic ideas that help manufacturers to implement an effective manufacturing process and to integrate quality within the company and the associated processes. These GMP guidelines may vary depending on local and national legislation. Meanwhile, almost all regulations are based on this basic GMP concept:

Quality management

The principle of quality management (QM) is to ensure that the products manufactured are suitable for their intended use, meet the requirements and do not endanger consumers due to inadequate safety or quality defects. These measures are taken care of by the company’s quality manager.

Quality assurance

The quality assurance system is designed to ensure that manufactured products are designed and developed to comply with GMP requirements.

Good manufacturing practice

As part of quality assurance, Good Manufacturing Practice deals with production and quality control. It aims at minimizing the risks inherent in the production process.

The Good Manufacturing Practices for Pharmaceuticals of the WHO (World Health Organization) refer to the following aspects:

  1. Explication and testing of manufacturing processes
  2. Validation of critical steps in the manufacturing processes
  3. The operational requirements for GMP are given:

    – qualified and trained personnel
    – adequate facilities and room conditions
    – suitable equipment and services
    – suitable materials, containers and labels
    – Approved procedures and instructions.

  4. Documentation of the entire process ‘
  5. Storage of the documentation
  6. Reducing the quality risk to a minimum.
  7. Internal system allows the retrieval of a single batch of a product from sales or delivery
  8. Complaints are investigated and the causes are eliminated.

Quality control

Quality control is part of good manufacturing practice. It is used to carry out samples, specifications and tests. This involves reviewing the facility, its GMP documentation and release procedures to ensure that the products pass the required tests before they are sold.

Quality risk management

Quality risk management serves the systematic identification and assessment of risks that could impair product quality. The relevant aspects for quality risk management are:

  • Sanitary and hygiene area

    The sanitary and hygiene area includes everything that can cause contamination, such as premises, personnel, equipment, containers and production material. All sources of contamination must be identified and regularly controlled.

  • Facilities

    The premises of a company should offer the lowest possible risk of contamination of materials and products. The premises should also be designed so that they are easy to clean and maintain, and so that errors in operation can hardly ever occur.

  • Equipment

    The devices should be designed and arranged in such a way that they can easily be used according to their intended purpose. They should be properly cleaned, stored and maintained. A defect or malfunction should always be marked.

  • Raw materials

    All materials required for production must be stored properly. A predefined warehouse management system is suitable for this purpose.

  • Personnel

    All employees must be qualified and trained for the specific fields of activity. They should be sensitized to the GMP guidelines. Training and hygiene instructions should take place regularly.

  • Validation and Qualification

    Qualification is intended to ensure that systems, premises and equipment are suitable for their intended use. Validation checks whether processes and procedures can repeatedly deliver high-quality products. If there are critical phases in the manufacturing process, these should be checked and documented to ensure consistent quality.

  • Complaints

    The handling of complaints is based on a predefined GMP complaints system. An ideal complaint management system should have a suitable resolution process for all eventualities.

  • Documentation and logging

    Accurate logging and documentation helps managers and supervisors to keep track of the history of the manufacturing process and the corrective actions taken. The basic requirements for GMP documentation follow:

  • Inspections and quality audits

    Inspections should be carried out regularly to monitor whether the GMP guidelines are implemented and adhered to. Areas that require more work are documented and corrective measures are provided for continuous improvement. Quality audits are performed to evaluate the quality systems implemented by the manufacturing company.

What is GMP compliant documentation? 4 tips for the compliance with GMP

GMP-compliant regulations optimize the safety of finished products, especially in the pharmaceutical industry. This enables the highest possible quality for consumers. The following 4 tips will help you to maintain GMP conformity:

  1. Build a team
    Have a team of professionals focused on improving current manufacturing processes and adherence to GMP. Members conduct quality assessments of operations to identify problems and develop appropriate corrective actions. The team’s responsibilities also include the scheduled monitoring of instruments, equipment, processes, and employee skills.
  2. Perform validations by
    Validation is a documented proof to demonstrate the functionality of measuring instruments, processes and activities that are regularly used or performed. In this way it is checked whether they function as expected. GMP may include a number of things that need to be validated, but it is good to focus on the following processes:
  3. Make use of surprise audits
    A surprise audit every now and then can help to gain a better insight into the
    into the events of the plant. Identify the real causes of non-compliance and take action before a major problem occurs.
  4. Focus on compliance training
    Providing training for employees is the best way to ensure GMP compliance. This gives employees a better understanding of Good Manufacturing Practices and continuously improves existing processes or systems to ensure that GMP standards are maintained. All employees should be trained in logging, hygiene, proper handling and labeling of equipment and SOPs to minimize errors and ensure compliance with regulations.
  5. How do digital technologies support GMP documentation?

    A GMP certification is achieved and maintained by following the seven GMP principles as well as continuous and consistent documentation. The use of software tools helps to rationalize and simplify the documentation of GMP records. Supervisors and employees are supported in the daily implementation of routine GMP controls.

    Lumiform is an inspection app and software that can help your company with GMP planning and documentation.

    • Carry out paperless GMP controls with any mobile device
    • Get notified about routine checks using automatic notifications
    • Use free digital GMP checklist templates and customize them to your company
    • Attach photos of any deviations directly to the controls and initiate corrective actions
    • Carry out temperature controls with sensors
    • Receive an automated report of all controls performed and forward it by e-mail to the responsible person for analysis.
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    • The GMP conformity of the guidelines results in a constant quality assurance of products such as food and pharmaceutical products and can be certified by systematic documentation.
    • There are a number of general principles which are adapted according to local and national legislation and operations and which are set by the WHO, among others.
    • GMP certification is best achieved through GMP team building, process validation, the introduction of surprise audits and training.
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