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GMP LOGFILE Features

2017-03-15

LOGFILE No. 10/2017 – What do GMP compliance and GEP mean?

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither

 

What does GMP compliance mean?

The meaning of the term GMP compliance becomes apparent in Article 8 of EU Directive 2003/94/EC:

  • (1) "[...] suit the intended operation."
  • (2) "[...] the quality of the product."
  • (3) "[...] critical to the quality of the products [...]"

This shows that GMP complianceis clearly linked to the requirements for the products manufactured using the company facilities. GMP compliance, therefore, cannot be achieved without knowledge of the product requirements. This constitutes a major and important difference to other engineering requirements for the construction of technical systems, facilities and equipment. A type examination for GMP compliance cannot be carried out, and the GMP compliance of each individual design must be proven.

This must be taken into account during facility planning, in particular. The relevant requirements must be discussed with the client at an early stage in the process. GMP risk analysis plays a central role in this context.

The regulations and directives that define the requirements for facilities and/or equipment apply to all technical systems and equipment used during the manufacture, storage and transport of medicinal products. It does not make a difference if they are mechanical aids, SPS-controlled facilities and devices, or computerised systems. All the equipment must be taken into consideration. However, this does not mean that all of the equipment used is critical. During a GMP risk evaluation, it is important to distinguish between critical and non-critical equipment. The planning procedure for critical equipment is more complex.

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Figure 4.A-4 Risk evaluation of critical and non-critical equipment

A critical element may be part of a forming set, but it can also be an entire production facility, a single autoclave or an entire cleanroom including infrastructure.

Good Engineering Practice

In accordance with the ISPE Baseline Guide Qualification & Commissioning, Good Engineering Practice (GEP) includes the following activities:

  • professional and competent project management (processes, specifications, personnel)
  • professional and competent engineering planning, procurement, design and technical commissioning
  • absolute compliance with all applicable legal requirements in respect of occupational health and safety and environmental protection
  • compliance with all requirements in respect of function and maintenance
  • absolute compliance with approved industrial standards and guidelines
  • appropriate documentation of established corporate processes and maintenance
  • documented proof of compliance with the relevant laws and regulations

GEP should generally be used for all facilities, equipment and technical systems.

However, it is always mandatory where the functions or components of facilities have the potential to affect the quality of the medicinal product in a critical way.

GEP is the foundation for the implementation of GMP. If adequate quality assurance is not in place at the suppliers and service providers of the technical systems, qualification and/or subsequent validation (manufacturing processes, cleaning processes, analytical methods) can only be carried out with a disproportionately large amount of effort. GEP sets the course for GMP-compliant order processing during all phases of the project. This not only applies to entire systems, but to technical subsystems as well.

The equipment supplier cannot take refuge in the fact that he/she is certified in accordance with ISO 900x. ISO certification does not guarantee GMP-compliant facilities, even though it is a good foundation and is taken into account during supplier audits. Figure 4.A-5 shows a comparison between ISO 900x and GMP.

Image
Figure 4.A-5 Comparison between ISO 900x and GMP

This text is an excerpt from the GMP Compliance Adviser.

Author:

Thomas Peither
Maas & Peither AG – GMP Publishing, Schopfheim

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