What are Good Manufacturing Practices (GMP) ?
Definition
Good Manufacturing Practices are a set of principles and guidelines. The first GMPs were published in France in 1978. These guidelines are regularly updated to incorporate regulatory changes.
The WHO defines Good Manufacturing Practices as “one of the elements of quality assurance, ensuring that products are manufactured and controlled in a uniform manner and to quality standards appropriate to their use and specified in the marketing authorization”. The aim is to guarantee the quality, safety and efficacy of medicinal products.
These Good Manufacturing Practices provide an understanding of the requirements of European regulations relating to the manufacture of medicinal products. They are one of the standards applicable to health products with marketing authorisation for the European market, as well as to experimental medicinal products.
The application of GMP by pharmaceutical establishments is verified by the competent authorities during inspections.
GMP compliance certificates issued by the ANSM following these inspections are published in the European EudraGMDP database.
Organisation of Good Manufacturing Practices
The standard is made up of 4 different parts plus appendices and guidelines. The 4 parts are as follows:
- Part I: GMP for medicinal products for human use
- Part II: GMP for active substances used as starting materials in medicinal products
- Part III: GMP-related documents
- ICH Q9: “quality risk management” guideline
- ICH Q10: “pharmaceutical quality system” guideline
- Part IV: GMP specific to innovative therapy medicinal products
The 10 Principles of Good Manufacturing Practice
There are 10 fundamental principles applicable to pharmaceutical operations which are taken from these chapters and which must be applied in order to guarantee the compliance of medicines:
- Creating procedures: writing operating procedures and instructions to provide a “road map”;
- Documentation: provide a precise description of the work in progress to ensure compliance with procedures and traceability;
- Validation: proving the correct operation of the systems in place by ensuring validation circuits;
- System design: integrating processes, product quality and staff safety right from the design phase of buildings, systems and equipment;
- Maintenance: regular and efficient maintenance of systems, installations and equipment;
- Skills: developing and clearly demonstrating skills at the workplace;
- Contamination prevention: adopting regular and systematic hygiene and cleanliness practices;
- Quality first and foremost: regular checks on raw materials and processes (manufacturing, packaging, labelling, etc.);
- Quality audits: planning and carrying out regular audits to ensure GMP compliance and the effectiveness of the quality system.
Conclusion
Compliance with Good Manufacturing Practices is essential. It is a regulatory obligation for pharmaceutical establishments. It is crucial to ensure product compliance and safety. Furthermore, during inspections by the health authorities, failure to comply with these standards may result in decisions of varying severity, depending on the non-compliance observed. The consequences of inspections can range from administrative warnings to sanctions.