Around the world, good manufacturing practice (GMP) defines and controls how manufacturers in certain industries should maintain quality control and reduce the risk they will produce a faulty product that causes harm.
But what is good manufacturing practice, and why is it important?
What is good manufacturing practice?
Defining good manufacturing practice (aka GMP)
Good manufacturing practice, or GMP for short, refers to a system of rules and best practices designed to help control the quality of pharmaceutical and other consumable products entering the market. Not only does GMP protect consumers from faulty goods, it helps manufacturers improve their quality and mitigate potential liability risks.
That’s the short version, anyway. Going into more detail, GMP isn’t just a set of guidelines but an entire certification process - countries around the world work hard to lay down rules and inspect manufacturers accordingly to ensure that they are complying with global standards. Many countries won’t allow the import of certain goods if they haven’t been certified.
- Read more: The Modern Manufacturing Guide
What are some of the risks GMP covers?
As mentioned, for manufacturers and customers, GMP helps to mitigate the risk that products will be produced with certain faults. For example:
- Contamination
- Incorrect labels
- Incorrect dosage of a particular ingredient
GMP also helps protect an organization’s people and equipment, as many of the rules are written to ensure staff are fully trained, equipped, safe, and that equipment is kept to a reasonable standard. In fact, GMP covers all aspects of a business from people to processes. We’ll talk more about that below in our section on the five Ps of GMP.
Does GMP only apply to pharmaceutical manufacturers?
We’ve talked mostly about pharmaceutical companies so far — those making medicine. But does GMP cover anyone else?
Yes, these standards also cover manufacturers producing a variety of products that must be made safe for human consumption. For example:
- Food and beverage manufacturers, including those producing dietary supplements
- Cosmetics manufacturers
- Medical device manufacturers
Other good practice regulations
A variety of other sectors also have their version of GMP. For example, those in farming or agriculture will likely be guided by good agricultural practice (GAP). Meanwhile, there’s good clinical practice (GCP) for hospitals and doctors, good laboratory practice (GLP) for labs, good distribution practice (GLP) for those distributing medical products, and more.
Why is GMP important?
Errors with a product can’t all be caught in a lab. If there were no common guidelines to follow at the manufacturing stage, there would be no way for governments or manufacturers to know that every unit in a particular batch would be made to the same quality and - more importantly - the same level of safety as whichever units were tested in the lab.
So, GMP is protecting consumers from the risk that they will purchase something with too high a dosage, or that contains a certain allergen that it’s not meant to. On the other side of the coin, manufacturers following these best practices are protecting themselves from the potential liability of producing a faulty product that causes customer harm.
In the end, GMP saves money. Using these rules manufacturers can catch errors early before a product goes to market, which means saving on the otherwise costly bill of product recalls and reputational damage. Customers save money by knowing they can trust a product. Governments save money on enforcement and regulation measures that might otherwise snowball out of control without GMP to guide everyone.
Being a responsible manufacturer means abiding by good manufacturing practices
Understanding the five Ps of GMP
We could write multiple articles on the specific legislation surrounding GMP, but what’s more important to learn today is not necessarily specific laws but the principles that guide those laws. And that’s where the ‘five Ps’ come in: people, premises, products, processes, procedures.
People
An organisation’s people are its greatest asset, and also potentially its greatest weak point. It’s often said that good people will do bad things if they have bad training - while perhaps slightly harsh, the sentiment is important: people must know how to do a good job in order to do it.
So what should you be asking yourself?
- Have we invested in staff training and competency?
- Do staff know the GMP rules for our territory?
- Do staff know how to stay safe and reduce risks at work?
- When was our training last updated?
- Do we have a policy in place to update training regularly to keep it relevant in future?
- Are the roles and responsibilities in our company clearly defined so people know exactly what they are doing each day?
- Is there a clear chain of communication for people to use if they have questions or concerns, and do they feel comfortable speaking up and using those channels?
Premises and equipment
Functioning, clean equipment is vital to success in manufacturing quality products and staying certified by your country’s GMP legislator. So, everything to do with your physical premises from the equipment it contains to its very layout must be factored against good manufacturing practices.
So what should you be asking yourself?
- Is our equipment clean?
- Is our equipment designed to prevent cross-contamination?
- Is our equipment validated and calibrated?
- Do we have procedures in place to guide the regular cleaning, maintenance and calibration of said equipment?
- Does the layout of our facility support everything mentioned above?
Products and materials
From what comes in to what goes out, every item that enters your facility must be handled with the same level of quality, care and scrutiny to reduce the chance an error may occur at one of the many points along a product’s journey from raw component to consumer product.
So what should you be asking yourself?
- Do we assess all of our primary materials for quality issues before putting them to use?
- Do we have goods handling procedures in place to ensure the careful handling and storage of all components and products in the facility?
- Have we clearly specified all the raw materials we require for our products?
- Do we have a master formula for our products that can be repeated without deviation to better guarantee quality control, and which factors every stage of the journey:
- R&D
- Processing
- Manufacturing
- Testing and sampling
- Record keeping
Processes
Well-defined processes can help a manufacturer stick to the legislative requirements surrounding GMP and produce quality, safe products every time. By taking time to investigate your various processes, document them, and ensure that they can be measured and assessed regularly, you’ll be putting yourself in a position to maintain quality control and continuously improve.
So what should you be asking yourself?
- Have we documented each of the processes in our organisation?
- Are these documents clearly defined and consistent with one another?
- Have we identified change control procedures in order to improve upon these processes in future?
- Could an independent GMP auditor use these documents to clearly follow our processes?
Good manufacturing practice depends on well-documented processes.Procedures
If your policies provide the guidelines and rules to follow in the business and your documented processes outline the journey of your products from end to end, then it is your procedures that are the step-by-step instructions of how to achieve those processes. In order to remain compliant with GMP legislation then your procedures must be detailed down to the nitty-gritties as well.
So what should you be asking yourself?
- For each of our process flows, do we have individual procedures clearly detailed?
- Are we missing any key procedures not directly related to the manufacturing process, i.e. whistleblowing, harassment or conflict mediation, what to do in case of natural disaster, and so on?
- Are our procedures documented, and are those documents consistent with one another?
- Could an independent GMP auditor view those documents and understand your procedures?
Quick facts about GMP around the globe
United Kingdom
Who runs GMP certifications in the UK?
It is the Medicines and Healthcare Products Regulatory Agency (MHRA) that performs GMP inspections in the UK.
How to get GMP certified in the UK
If you are a new manufacturer looking to become certified, you will be inspected by the MHRA when you apply for your manufacturer's licence. From then on, you will be inspected on a regular basis. If the MHRA deems your organisation to be at a higher risk (based on their risk ratings system), you may be inspected more frequently as a priority
European Union
Who runs GMP certifications in the EU?
In the European Economic Area, GMP inspections and certification is coordinated by the European Medicines Agency (EMA). However, each nation typically has its own inspectors run by the local regulatory authority.
How to get certified in the EU
Each country in the EU has its own regulatory body and so manufacturers must apply to the applicable authority for their country. That said, the EMA plays a large role in harmonising these individual agencies by coordinating guidance on GMP, ensuring common interpretation of EU GMP requirements, and developing EU-wide procedures on inspections.
- Read more: Good manufacturing practice (EMA)
United States
Who runs GMP certifications in the US?
The US Food & Drug Administration (FDA) controls the GMP regulatory and inspection process in America, using its Current Good Manufacturing Practice (CGMP) guidelines.
How to get certified in the US
In order to be certified to manufacture pharmaceutical and related products in the US, you will have to apply for approval with the FDA. At that point FDA assessors will arrive to determine if your company has the necessary equipment and ability (the five Ps) to safely manufacture what you intend to make.
Australia
Who runs GMP certifications in Australia?
The federal Department of Health’s Therapeutic Goods Authority (TGA) controls manufacturing licenses and GMP certification in Australia.
How to get certified in Australia
If your manufacturing facility is in Australia, you’re manufacturing applicable goods and you have no exemptions, rather than GMP certification you will need to apply for a manufacturing licence. Companies that are based overseas may need to apply for GMP certification by the TGA if the TGA does not recognise the local regulatory body’s standards as being similar enough to Australia’s own.
Medical devices are also licensed separately to other therapeutic goods such as medicines, with manufacturers of these products requiring a Conformity Assessment Certificate.
New Zealand
Who runs GMP certifications in New Zealand?
New Zealand manufacturers must conform to standards outlined by the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods - which is held by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
How to get certified in New Zealand
Medsafe refers to the above-mentioned code whenever a manufacturer applies for a License to Pack Medicines or Licence to Manufacture Medicines, or for a GMP certificate. An auditor may come to your premises to check for compliance, although this may not be necessary if you can produce equivalent compliance documents from a recognised overseas agency.
- Read more: Medsafe: Manufacturing (Medsafe)
Third-party GMP certifiers
While ultimate authority over GMP certification sits with local regulatory bodies, there are a variety of third-party companies around the world that specialise in such legislation and can help you prepare for your inspections and/or provide their own certifications (i.e. the NPA in the US).
If you’re not confident about passing an inspection or are simply unsure of what you need to do, it may be worth your time speaking to such a company for their advice. Of course, we can’t guarantee results with a third party but it never hurt to at least check what’s out there in the market.
Conclusion
Good manufacturing practices exist to protect customers and manufacturers alike from the risk of faulty products. They combine a mixture of best practices - known as the five Ps of GMP - as well as strict legislation to ensure compliance and mitigate the risk that a harmful product may end up in the market.
Other resources
GMP certification and GMP certificate in Europe – an overview
SGS Good Manufacturing Practice (GMP) Certification
SMPNutra - Who Gives GMP Certification?
Australia Department of Health - Good manufacturing practice overview
