What is GMP?

GMP (Good Manufacturing Practices) is a quality system that guides manufacturers, particularly in sectors that impact human health such as food, pharmaceuticals, cosmetics, and medical devices, on what conditions and how products should be produced according to the GMP standard. The use of the GMP standard is particularly referred to as cGMP in the United States. The letter “c” at the beginning of the GMP standard is the abbreviation of the English word “Current,” implying “dynamic.”

As foreseen and fundamental in other standards, the GMP standard is not a system established once; it is a production technique that is continuously monitored and controlled, where systemic or operational deficiencies identified during these controls are corrected, and which evolves by incorporating innovations brought by modern technology and sectoral practices.

These practices covered by GMP are among the fundamental approaches in the production and distribution of food products and can also be described as a series of techniques that must be applied uninterrupted in the stages of raw materials, processing, product development, production, packaging, storage, and distribution to ensure quality in products.

GMP (Good Manufacturing Practices) also functions as a common argument for guides, codes, and regulations created for active substances and pharmaceutical/medical products, products used in and on the body, and food manufacturers.

Why should GMP be implemented?

• The GMP factor provides high assurance regarding the reliability, efficacy, and quality level of produced medicines during their production methods stage.

• With GMP, medicines are produced considering their compliance with marketing authorization.

• GMP establishes production quality and prepares it for sectoral requirements.

• Testing is a part of GMP, but without GMP, it alone does not mean a high level of quality assurance.

What are the Focus Points of GMP (Good Manufacturing Practices) in Our Production?

1. Quality Assurance

2. Good Manufacturing Practices for Pharmaceutical Products

3. Sanitation and Hygiene

4. Qualification and Validation

5. Complaints

6. Product Recall

7. Contracted Production and Analyses

8. Internal Control and Quality Audits

9. Personnel

10. Training towards Good Manufacturing Practices

11. Personnel Hygiene

12. Facilities

13. Equipment

14. Materials and Supplies

15. Documentation

16. Practices in Production

17. Practices in Quality Control

What are the basic requirements of GMP?

• Performing qualification and validation

• Providing suitable resources in the following factors:

  • Qualified and trained personnel (towards GMP)

  • Facilities, production area, equipment, and services (towards GMP)

  • Materials, containers, labels (towards GMP)

  • Procedures, storage, logistics (towards GMP)

  • Laboratories and in-process control (towards GMP)

  • Clear, written instructions and procedures (towards GMP)

  • Trained operators (towards GMP)

  • Records of activities, deviations, and investigations (towards GMP)

  • Records kept for production and distribution (towards GMP)

  • Suitable storage and distribution conditions (towards GMP)

  • Systems for complaints and recalls (towards GMP)

GMP (Good Manufacturing Practices) Validation

What is GMP validation?
GMP validation is a member of the quality assurance program established for pharmaceutical/biotechnology products and processes.

The purpose of its application is to guarantee that the final product produced by the company is fully suitable for its intended use. The organization must documentarily demonstrate that the equipment, tests, activities, methods, and processes it has used and/or applied during production are competent to consistently obtain the desired product. Therefore, GMP must verify that each critical stage of the production process yields the intended product under defined conditions.

The accepted definition for Validation is the definition determined by the WHO (World Health Organization).

WHO (World Health Organization) Definition of Validation:

• Documented activities must prove that the applied procedure, process, equipment, material, activity, or system provides assurance that the expected results will be achieved.

Why should a GMP audit be performed?

• GMP provides a commitment to safe food production and trade.

• GMP builds greater consumer confidence.

• GMP ensures compliance with the necessary minimum standards for food producers/processors.

• GMP increases operational efficiency by streamlining processes and reduces non-conforming activities.

• GMP forms a basis for the organization’s certification regarding other food safety standards and HACCP.