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

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