If you’re manufacturing food, drinks, or medicine, you know you have a sea of regulations and standards which you need to hit and adhere to.
You knew that starting out.
But it does leave you with two questions:
- What are the regulations and standards that I should adhere to?
- How do I get my organization to run in an effective manner so that we consistently adhere?
Lots of companies are very good at asking the first question, but the second sometimes gets overlooked.
This is how we end up with malpractice and lawsuits and all kinds of bad things.
You don’t just have to know what the standards are, or intend to reach those standards, but you have to consistently hit those standards in order to be the successful safe business you want to be.
That’s why in this Process Street article we’ll be looking at:
- What is CGMP? Current Good Manufacturing Practices explained
- What are the current Good Manufacturing Practices?
- What is a Quality Management System and how does it help CGMP?
- How Process Street can help you build your Quality Management System
What is CGMP? Current Good Manufacturing Practices explained
Good Manufacturing Practices (GMP) are the recommendations for businesses which need to adhere to the guidelines set by regulatory bodies in regards to the manufacture or sale of a range of products: food, drinks, medicines, cosmetics, and medical devices, primarily.
There are different regulatory bodies which oversee these terms depending on what country you’re in:
- The United States has the U.S. Food & Drug Administration (FDA)
- The United Kingdom has Medicines and Healthcare Products Regulatory Agency (MHRA)
- South Korea has the Ministry of Food and Drug Safety (MFDS)
- Australia has the Therapeutic Goods Administration (TGA)
- Bangladesh has the Directorate General of Drug Administration (DGDA)
- South Africa has the Medicines Control Council (MCC)
- Brazil has the National Health Surveillance Agency (ANVISA)
- India has the Central Drugs Standard Control Organization, which is comprised of a series of regional bodies
- Pakistan has the Drug Regulatory Authority of Pakistan
- Nigeria has the National Agency for Food and Drug Administration and Control (NAFDAC)
Which means, if you’re looking for country-specific advice and regulatory detail then you’re in the wrong place and you should search the relevant authority in your region.
There are also transnational GMPs you should look out for depending on your industry, including standards from:
- The European Union
- World Health Organization
- International Conference on Harmonization
“But”, I hear you ask, “why is it called C-GMP?”
And that’s a good question, but one with quite a simple answer. The addition of current is there to signal to manufacturers that these recommendations are updated on a regular basis. In the US, we’re talking every 10 years.
So you need to keep on top of the regulatory environment even if the iterations of the practices tend not to change too much – the exception being areas like electronic reporting and such, where technology tends to move faster than standards can keep up.
These standards can be quite broad and wide-ranging but are generally designed to be adhere-able. So you shouldn’t get too scared of them. The FDA describes its regulations pertaining to drugs as:
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
What are the current Good Manufacturing Practices?
The recommended practices are obviously too detailed for me to work through them all step by step here in this article.
However, we can look at an overview of the general principles which underlie all GMPs.
The following points are from a World Health Organization book titled Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials; Good Manufacturing Practices and Inspection, Volume 2 (2007) – which you can access in its entirety on that link if you’re really serious about this kind of thing. Which you should be.
- Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP).
- Production and control operations are clearly specified in a written form and GMP requirements are adopted.
- Managerial responsibilities are clearly specified in job descriptions.
- All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
- The finished product is clearly processed and checked, according to the defined procedures.
- Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products.
- Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life.
- There is a procedure of self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
- Deviations are reported, investigated, and recorded.
- There is a system for approving changes that may have an impact on product quality.
- Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
The above is basically a system of quality assurance. What you see in those 11 points is a framework of quality assurance which applies directly to GMP.
While CGMP will contain further more detailed specifications relating to certain industries, product types, or other variables, it all fits within the overarching framework of quality assurance exampled above.
So, in short, if you want to adhere to current Good Manufacturing Practices, you need to have a quality assurance system in place which can deal with all of the above points.
This might seem intimidating – long words and complex sentences often have that effect – but it doesn’t have to be.
All of this is achievable via four concepts:
- Policy: A policy is a stated aim of an organization; a principle which its operations should adhere to.
- Process: A process is a flow within an organization whereby resources or information get transformed.
- Procedure: A procedure is a specified step by step way of approaching a given task.
- Audit: An audit is an event where an organization or one of its parts is checked to see whether it meets certain criteria.
Combine these four concepts together effectively and you have a quality management system.
What is a Quality Management System and how does it help CGMP?
A quality management system is a way to keep a large organization running smoothly.
The rough idea is that you document your policies, processes, and procedures, and then make sure you’re operating day-by-day in a way which adheres to those documents.
It has to be implemented. People need to follow the procedures, and the procedures need to have been created with the policies in mind and the processes understood.
If we take a look at probably the most famous quality management system, ISO 9000, or more specifically ISO 9001:2015, then we’ll see a slightly more holistic approach to quality management than was outlined in the quality assurance points from the WHO.
ISO 9001:2015 defines the 7 principles of quality management as being:
- Customer focus
- Engagement of people
- Continuous improvement
- Evidence-based decision making
- Relationship management
So – focus on the value you’re giving the customer and make sure that ethos comes from the top. Empower your staff to try to service that customer need and to figure out the internal processes which can best deliver that service. Then evaluate, inspect, and iterate those processes to make them better. Formalize that improvement system so that you can do it again and again and again – but make sure it’s based on evidence, metrics, and your approaches can be verified from the outside. Oh, and try not to rip anyone off; ethics are free.
The effective use of policies and processes to deliver that system is pretty much what quality management is.
If you’re still not certain, check out this example ISO 9001:2015 QMS Mini-Manual we created for a fictional marketing company called Brightstar Marketing. Click through the initial sections to read the policies and scroll through to see the procedures.
You can see more about that template in this detailed post of ours about it: How to Write an Actionable Policy and Procedure Template (ISO Compliant!)
If you like that one, you can either add it straight to your free Process Street account or you can add this one below instead. The one below is a blank template version of the above which you can fill in yourself according to the instructions.
Now, our approach would likely be to build out all your procedures in Process Street first before compiling short versions of them in your process manual, but if you’re in manufacturing then you likely already have them written down somewhere – so feel free to just throw them in.
But how do I make a QMS for CGMP?
Well, let’s go back to the WHO principles for the production of pharmaceuticals.
We’ll look at each one by number and see how it relates to a QMS.
- Your procedures for designing and developing new products should be documented and those procedures should adhere to regulations.
- Make sure your documented production procedures adhere to regulations. Update the procedures if regulations change.
- Your recruitment procedures should make managerial responsibilities clear.
- You should have procedures which apply to control testing.
- Make sure you have procedures for checking finished products.
- Batches of products should be checked before going on sale. This should be part of your documented process.
- Ensure you have procedures for not damaging the products. Put handle-with-care stickers on your boxes, etc.
- Perform regular audits on how good your procedures are.
- Make sure you have a documented process for deviations so that you can find out what went wrong and try to fix it for the future.
- Have a documented process for any product improvements.
- Audit your product quality and try to improve it.
Do you see?
That 11 point list was just a series of policies, processes, procedures, or audits which the World Health Organization wants you to have documented, and then to follow.
Isn’t it a lot less intimidating now when you see that this is basically just a bunch of checklists which you need to use in your business to show you’re taking things seriously?
Now look at that Marketing Procedures template embed again above and think about how you would do it if you needed to have these kinds of WHO procedures in place.
How Process Street can help you build your Quality Management System
Process Street is superpowered checklists.
That checklist then exists as a single instance record of your activity. You can add upload fields, form fields, or include team members, to gather information in the checklist. All of that activity from each checklist is saved in the Template Overview as a database-style record of activity.
Checklists can link to checklists or can trigger automations in other apps. You can create stop tasks or required fields to make sure no one skips ahead. You can build it really easily with conditional logic so the tasks in the checklist change in real-time depending on what information has been entered or selected.
You can create:
- Accounting processes
- IT processes
- HR processes
- Security processes
- Inspection processes
- ISO QMS audit processes
- Sales processes
And processes specific to your business.
You can even use the Mini-Manual template above to compile overviews of all these processes in one single document.
Process Street is an off-the-shelf quality management system for your business.
How did you construct your CGMP QMS? What were your main challenges? Let us know in the comments below!