Eudralex Volume 4: the 11 requirements of GMP

Published: 29-Jun-2022

Good Manufacturing Practice (GMP) is essential in the production of pharmaceuticals, to ensure consistency, control, and quality throughout the manufacturing process

In Europe, we follow GMP guidelines set out by the European Commission in EudraLex Volume 4. According to this, there are 11 basic requirements of GMP, intended to regulate both the production, and quality control of products. Here’s what they are:

i) Processes should be clearly defined and reviewed to show that the manufacture of products comply with their specifications

Every step should be documented and follow clearly defined procedures
These procedures should be reviewed regularly to ensure that they allow for consistent manufacture, and allow products to be manufactured to their specifications

ii) Critical steps of the manufacturing process should be validated

This should ensure that the steps can be performed consistently, and produce the desired outcome
Any significant changes to the process should also be validated to ensure these changes do not alter the desired outcome

iii) All necessary facilities for GMP are provided, ensuring that GMP requirements can be met. These facilities include:

Qualified and trained personnel
Ensuring tasks can be carried out correctly by competent staff members
Adequate premises and space
Not only should the correct facilities be in place to allow for the manufacture, but adequate space should be provided to ensure that processes can be carried out effectively
    • Limited space can increase the risk to the product
  • Suitable equipment and services

    Equipment and services should be validated and maintained to ensure that they are suitable for the processes being carried out
  • Correct materials, containers, and labels
Ensuring that the correct materials are available is essential to ensure that manufacture can be carried out to the correct standard
  • Containers must be suitable for the processes being carried out
    • Labels must be correct for starting materials, intermediates and for finished product to ensure it is clear what each material contains
  • Approved procedures and instructions
    • Ensuring that personnel are able to follow these procedures and instructions, which have been set out in the pharmaceutical quality system and approved
  • Suitable storage and transport
    • Ensuring that products can be stored and transported correctly is essential to maintain the quality of the product before distribution

iv) Instructions and procedures should be written in clear and unambiguous language

This should ensure that they can be followed easily, ensuring personnel can consistently follow these instructions
Instructions should be specifically applicable to facilities available

v) Procedures are carried out correctly, and operators are trained to do so

If procedures are clear and personnel trained correctly, procedures can be carried out correctly and to a high standard

vi) Records should be made to demonstrate that all steps were taken

  • This provides assurance that the correct procedures were followed, and that the quality and quantity of product met expectations during manufacture
  • This is applicable for both procedures performed manually, and also for those performed using instruments which record results and statuses

vii) Any significant deviations are fully recorded and investigated

  • Investigations should aim to identify why the impact of the deviation, why it occurred, and implement corrective or preventative actions to prevent the deviation from reoccurring

viii) Records of manufacture and distribution must be retained in a comprehensible and accessible form to ensure that the history of the batch can be traced if required

  • This ensures that if any issues are discovered, there is full traceability of the manufacturing process and where products have been distributed to

ix) The distribution of products minimises any risk to their quality and takes account of Good Distribution Practice

  • Ensuring that no additional risk is placed on the quality of the product during distribution

x) A system is available to recall any batch of product, from sale or supply, in case of defects or issues detected in manufacture after release

  • If issues or defects are identified, there must be a way to ensure that any product which has been released can be recalled minimising risks

xi) Complaints about products are examined and any defects are investigated

  • Measures should be taken to prevent reoccurrence if defective products are discovered

If you or your team could benefit from learning more about GMP within a pharmaceutical setting, click here to watch our webinar series: A Guide to GMP.

The 4-part series of 20-minute-long webinars covers:

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