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7th March 2023  Content supplied by: Microgenetics

The 11 Requirements of GMP in Pharmaceutical Manufacturing

If you work in Pharmaceutical manufacturing, you’ll know that Good Manufacturing Practice (GMP) is essential to ensure consistency, control, and quality in your end product.

But do you know the 11 requirements of GMP according to EudraLex Volume 4? Or what you have to do in order to meet these requirements?

First, let’s talk briefly about EudraLex.
EudraLex is the collection of rules and regulations governing medicinal products in the EU. If you’re in the USA, you’re governed by the FDA.

Although EudraLex consists of 10 Volumes, only Volume 1 and 5 present official legislation. The other 8 Volumes – including Volume 4, which we’re interested in here - are for guidance.

Within Volume 4, 11 basic requirements of GMP are set out. Following these is important to meet regulation, whilst reducing errors, operational costs and speeding up time-to-market.

Here’s what the 11 requirements are:

  1. Processes should be clearly defined and reviewed to show that the manufacture of products complies 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
  2. 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
  3. 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
    Correct facilities and adequate space should be in place to allow for processes to 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 so 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
  4. Instructions and procedures should be written in clear and unambiguous language

    This should ensure that they can be followed easily by personnel

    Instructions should be specifically applicable to facilities available
  5. 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
  6. 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 for those performed using instruments which record results and statuses
  7. Any significant deviations are fully recorded and investigated

    Investigations should aim to identify the impact of the deviation, why it occurred, and implement corrective or preventative actions to prevent the deviation from reoccurring
  8. 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
  9. 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
  10. 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
  11. Complaints about products are examined, and any defects are investigated

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

As these guidelines apply to all stages of production and Quality Control, anyone working within your facility should be trained fully to understand these requirements. This training should be kept up to date.

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:

Part 1: What is GMP?
Part 2: GMP Personnel and Documentation
Part 3: Quality Control
Part 4: Minimising Contamination

To contact Microgenetics directly, use the Request Information below.



Date Published: 7th March 2023

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