In this blog post, we take a detailed look at GMP, what this involves, and why it's such an important part of medicine production.
What does GMP mean?
GMP stands for good manufacturing practice. This is the minimum standard that a medicines manufacturer must meet during their production processes.
[more]A GMP system ensures that products are manufactured in a consistent, controlled way that's compliant with applicable quality standards. Good manufacturing practices are designed to minimise the risks involved in pharmaceutical production - especially risks like mislabelling, adulteration and cross-contamination (i.e. risks that cannot be eradicated through testing the final product).
According to UK government guidance, products must:
- Be appropriate to their intended use
- Be of a consistently high quality
- Meet the requirements of the marketing authorisation or product specification
The European Medicines Agency (EMA) coordinates inspections to verify compliance with the above standards. The EMA also plays a vital role in synchronising GMP activities at the European Union (EU) level; however, good manufacturing rules change frequently and differ from one country to the next.
Organisations that may have to comply with good manufacturing practices include:
- Manufacturer licence holders
- Wholesale dealer licence holders
- Blood establishment authorisation holders
- Non-UK sites employed by UK marketing authorisation holders
The five Ps of GMP
The regulation of good manufacturing practices is very important. Regulation ensures consistent quality and safety of products produced.
In order to comply with the strict standards that govern pharmaceutical manufacturing, organisations should follow the five Ps of GMP. These are:
1. People
Each employee involved in the manufacturing process is expected to adhere to the strict processes and regulations that are in place. All employees should be trained to understand their individual roles and responsibilities, and performance assessments should be carried out to help improve productivity, efficiency and competence.
2. Products
All manufactured products must be put through constant testing, comparison and quality control before they are released to consumers.
3. Processes
All manufacturing processes must be properly documented. This documentation should be clear, consistent, and given to every worker. Frequent assessments should be conducted to ensure all employees are following the correct processes.
4. Procedures
The guidelines for carrying out the correct processes in order to achieve a consistent result should be followed by all employees at all times. Any deviation from standard procedures, for any reason, should be reported and investigated immediately.
5. Premises
All manufacturing premises should promote cleanliness at all times to avoid the risk of cross-contamination, accidents and fatalities.
GMP regulations
GMP regulations are authorised by national governments to regulate the production, verification and validation of manufactured products and ensure that they are effective and safe for distribution. Visit gov.uk to view the UK government's GMP guidance.
The quality of manufactured products is highly regulated, and with good reason - pharmaceutical products can pose a significant risk to consumer health and the environment if the correct processes aren't followed.
Complying with good manufacturing practices helps to avoid problems caused by poor hygiene, cross-contamination and poor temperature control.
Meeting GMP standards
Good manufacturing standards are developed to improve the safety of manufactured products (in particular pharmaceutical goods) and to ensure that consumers receive the best possible quality.
By following GMP standards, manufacturers can cultivate positive reputations while also reducing the number of product recalls and negative reviews from consumers.
In order to meet GMP standards, a company needs skilled, highly-trained workers. Additional measures - such as surprise audits and rigorous validation checks - may also be used to ensure compliance.
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In summary, good manufacturing practice involves a prescribed set of processes and standards that must be followed at each stage of any manufacturing process to make sure the finished product - the one released to the general public - is fit for purpose. GMP is especially crucial when producing vaccines, medicines and medical devices.
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