GMP (Good Manufacturing Practice)

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

What is GMP?


The system of Good Manufacturing Practice (GMP) ensures that manufactured products such as food, cosmetics and pharmaceutical products are consistently produced and controlled according to defined quality standards. Every aspect of the manufacturing process is examined and covered by GMP to protect against product risks such as cross-contamination, adulteration and incorrect labelling. The implementation of GMP can help to reduce loss and waste, and protect both the company and the consumer from negative food safety incidents.



In this article you will learn more about:


1. The GMP regulation


2. The 12 GMP guidelines


3. Compliance with GMP guidelines



The GMP regulation


The quality of manufactured products is strictly regulated, as it could pose negative health risks to consumers and even to the environment. Good examples of how a manufactured product that does not comply with GMP guidelines can have fatal consequences for consumers are: poor hygiene and inadequate temperature controls, cross-contamination and adulteration.


The GMP rules are followed by many manufacturers all over the world. The respective national governments are responsible for regulating the production, verification and validation of manufactured products and for ensuring that they are effective and suitable for market distribution.


In the USA, for example, GMP is enforced by the US FDA through the Current Good Manufacturing Practices (CGMP), which cover a wider range of industries such as cosmetics, food, medical devices and prescription drugs. In Europe, relevant guidelines for the pharmaceutical sector are controlled by the European Commission, through the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).


The relevant authorities carry out factory inspections to determine whether a manufacturing company complies with the GMP guidelines. If serious violations are found during the inspection, all products are recalled, which is problematic for the manufacturers both in terms of profit and business operations.



What are GMP guidelines?


The 12 GMP guidelines contain several basic ideas that help manufacturers to implement an effective manufacturing process and to integrate quality within the company and the associated processes. As a rule, the GMP guidelines are flexible, although countries with their legislation follow their local guidelines and principles. But almost all regulations are derived from the basic GMP concept and the associated GMP guidelines:


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, quality or action mechanisms. Therefore, quality assurance, GMP standards, quality control and quality risk management should be fully and correctly implemented to achieve this quality objective.


  • Quality assurance The quality assurance system aims to ensure that manufactured products are designed and developed to meet GMP requirements.

  • Good manufacturing practice for products As part of quality assurance, Good Manufacturing Practice deals with production and quality control. It aims to minimize the risks inherent in the production process.

  • The essential requirements according to the WHO (World Health Organization) Good Manufacturing Practices for Pharmaceuticals are as follows:


    1. All manufacturing processes are clearly explained, are systematically and practically checked and are demonstrably capable of consistently producing medicinal products of the required quality and of complying with their specifications and/or the marketing authorization.

    2. Critical steps in the manufacturing processes and fundamental changes to the process are validated.

    3. All necessary requirements for GMP guidelines are provided, including (1) appropriately qualified and trained personnel; (2) adequate facilities and room conditions; (3) appropriate equipment and services; (4) appropriate materials, containers and labels; (5) approved procedures and instructions.

    4. Instructions and procedures shall be written in an instructive form in clear and unambiguous language specific to the facilities provided.

    5. The employees are trained to carry out the procedures correctly.

    6. During production, records are made manually and/or by the equipment. These are intended to prove that all steps required by the defined procedures and instructions have actually been carried out. It must also be ensured that the quantity and quality of the product meet the expectations. All significant deviations are recorded and investigated in full.

    7. Records of production, including distribution, which enable the complete batch history to be traced, are kept in an understandable and accessible form.

    8. The distribution (wholesale) of the products reduces the quality risk to a minimum.

    9. A system is available to retrieve each batch of a product from the sale or delivery.

    10. Complaints about marketed products are investigated, the causes of quality defects are identified, and appropriate measures are taken with regard to the defective products and to prevent their recurrence.

  • Quality control An important part of good manufacturing practice is quality control. It focuses on samples, specifications and tests. The organization, GMP documentation and release procedures are reviewed to ensure that the products pass the required tests before they are released for sale or delivery.

  • Quality risk management Quality risk management is a systematic process that helps to identify risks that may affect product quality. According to its principles, quality risk management should ensure that:

  1. The assessment of the quality risk is based on scientific knowledge, experience with the process and ultimately on the protection of patients and users.

  2. The effort, formality and GMP documentation of the risk management process depends on the hazard potential.

  3. The general risk management process and its integration into product quality can be described in the ICH Q9 guideline.

sanitary and hygiene area


The sanitary and hygienic area is of crucial importance in every aspect of the manufacturing process. It includes everything that can cause contamination, such as premises, personnel, equipment, containers and production materials. All possible sources of contamination should be identified and eliminated with a detailed sanitation and hygiene programme.


buildings and equipment/rooms


In principle, the premises should be located in an environment suitable for the operation. There should be no risks for contamination of materials and products. Besides, the premises should be easy to clean and maintain so that operating problems hardly ever occur.


Equipment


As with the premises, equipment should be designed, located and maintained so that it functions as intended. They should also be cleaned and stored by procedures. In the event of a defect or malfunction, they should be removed or marked as defective.


raw materials


All materials used for production should be properly stored according to the conditions specified by the manufacturer as appropriate. An appropriate warehouse management system should be implemented to ensure that all incoming materials are correct and of high quality.


personnel


A successful implementation of GMP standards depends heavily on the people who implement them. For this reason, it is important that all employees are qualified and trained for this task. They should be aware of the GMP guidelines. Continuous training, hygiene instructions and other instructions important for their needs should be provided. The responsible managers should be aware of the job descriptions for each employee to avoid misunderstandings and reduce the risk of problems such as overlapping responsibilities.


Validation and qualification


The qualification is intended to ensure that systems, premises and equipment are suitable for the intended purpose. Validation checks whether processes and procedures can repeatedly deliver high-quality products. Critical phases in the manufacturing process should be reviewed to ensure that product quality is consistent and maintained at a high level. According to the WHO, qualification and validation should provide GMP documentation that confirms the following points:


  1. The premises, supporting utilities, equipment and processes have been designed by GMP guidelines.

  2. The premises, supporting utilities and equipment were built and installed by their design specifications (Installation Qualification or IQ).

  3. The premises, supporting utilities and equipment are operated by their design specifications (Operational Qualification or OQ); and a specific process

  4. consistently produces a product that meets its predetermined specifications and quality features (Process Validation or PV, also known as Performance Qualification or PQ).

complaints


The handling of complaints is also part of GMP, so all manufacturing companies should have a well-thought-out GMP complaints system. An ideal complaint management system should have a suitable resolution process for all eventualities.


Documentation and logging


Good GMP documentation and record-keeping is an essential part of the quality assurance system and is required by the GMP guidelines. Accurate logging helps managers and supervisors to keep an overview of the history of the manufacturing process and the corrective actions taken. All general requirements for GMP documentation are listed below:


  1. The documents must be designed, prepared, checked and distributed with care.
  2. The documents should be clear and legible.
  3. The documents must be approved, signed and dated by the appropriate personnel.
  4. The documents must have explicit contents such as title, type and purpose.
  5. The documents must be checked and updated regularly.
  6. The documents must not be handwritten. All corrections made to a document or record must be countersigned and dated. The reason for the correction should also be recorded (if applicable).
  7. Every action taken for traceable activities such as the manufacture and control of products must be recorded.

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 carried out to evaluate the quality systems implemented by the manufacturing company.


GMP audit checklists support companies in complying with the GMP guidelines laid down by the supervisory authorities. By conducting visual inspections on site and carrying out production evaluations, non-compliant processes are identified. Measures are then taken immediately to exploit improvement potential.



So you comply with the GMP guidelines


GMP-compliant regulations are developed to increase and ensure the safety of finished products, especially pharmaceutical products. The aim is to provide consumers with the highest possible quality. Compliance with GMP not only has a positive effect on the reputation of manufacturing companies but also reduces batch recalls and negative evaluations by consumers. Below you will find 5 measures that you can follow to maintain GMP conformity:


  1. Quality 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. Validation Validation is a documented proof to demonstrate the functionality of measuring instruments, processes and activities that are regularly used or performed. It is used to verify that they function as expected. GMP may include several things that need to be validated, but it is good to focus on the following processes:

    1. Process Validation
    2. Validation of cleaning and sanitary facilities
    3. Validation of analytical methods
    4. Validation of the computer system

  3. Surprise audits A surprise audit now and then can help to gain a better insight into the events of the plant. Identify the real causes of non-compliance and take action before a major problem occurs.

  4. Conformity training Providing training for employees is the best way to ensure GMP compliance. This gives employees a better understanding of Good Manufacturing Practices and allows them to continuously improve existing processes or systems to ensure that GMP standards are maintained. All employees should be trained in logging, hygiene, proper handling and labelling of equipment and SOPs to minimize errors and ensure compliance.

  5. Strengthening of GMP in companies Robust processes and easy-to-use systems for enforcing and monitoring standards strengthen compliance with GMP guidelines in your company. As the industry advances technologically, food manufacturers have more opportunities to transform a reactive culture into a proactive, forward-thinking one that is equipped for continuous improvement. Use digital tools such as the Lumiform app and sensors to improve your GMP beyond compliance.



Featured templates

GMP Site Walkthrough Checklist

GMP Site Walkthrough Checklist

Conduct routine visual site inspections and check the overall safety of the production place using this GMP Site Walkthrough Checklist. See template

GMP Food Manufacturing Audit Checklist

GMP Food Manufacturing Audit Checklist

Used this template to review efficient processes and staff training on proper hygiene procedures. See template

GMP Compliance Checklist

GMP Compliance Checklist

A GMP compliance checklist is used to assess a manufacturing company's compliance with manufacturing reports. See template