This will be a series of blog postings in which using that presentation I will outline some regulatory background, the QA process and then the manufacturing steps through to when the product is dispatched to our customers.
Before I start, the photo that you see is where we are based in Christchurch New Zealand.
This photo was taken before the series of earthquakes which started in Sept 2010 with the most severe one last February. The city skyline is a bit different now in that the high rise buildings that you see in the background have all now being demolished along with another 1000 buildings in the CBD. Some of the houses you seen in the foreground are no longer there as large pieces of the cliff 'shaved off' in the last big shake last June.
Fortunately the quakes have now settled down and with a bit of luck will be stable for the next 1000 years or so. As I have mentioned in earlier blog posts, we were lucky in that our factory, offices and warehouse although damaged were all repairable so we had minimal disruption.
OK, let's start!
The objective of the A4M presentation was:"To present an overview of how supplements are manufactured"
This will consist of the following:
1. Regulatory Overview
- Overview of GMP
- Myths about the US FDA
Some countries have strict regulations, some don't. Those Countries with clear cut rules and enforcement are: Australia, Canada, USA.
New Zealand has regulations and subject supplement companies to standards and audits. However, some of the regulations are somewhat dated and new regulations have been prepared and are currently going through the select committee process before being submitted to Parliament.
Because the majority of our customers are in the USA we operate under USA FDA guidelines (cGMP).
Some background about US GMP
- When it was first proposed some years ago there was a lot of opposition from manufacturers because of the extra costs it would impose.
- The GMP code is very comprehensive and in our opinion reasonable and necessary.
- On the 28th June, 2010 every company wanting to sell products in the US or to the US market should be GMP compliant. Sadly as at 2011 apparently about 70% of US manufacturers will still not compliant.
- US FDA started visits to inspect foreign manufacturers facility as from October 1, 2010
There is a lot of misunderstanding about what an FDA registered facility is. Here are the key points:
- The US FDA does not approve any facility. The only time that a supplement manufacturing facility may get an 'indirect approval' is if the FDA does a surprise audit and the facility if found compliant in all respects and no rectification notices are issues. That does still not amount to approval but rather that the facility was compliant at the time of audit.
- As such there is no list of FDA approved facilities
- There is however a list of FDA registered facilities which we are on
- There is not a list of GMP compliant facilities
- The FDA Registration of facilities came about as part of the “Bioterrorism Act of 2002”
I felt it was important that the above was made clear as there is a lot of misinformation about GMP and regulations, particularly on the internet. Also, contrary to what some media and others may say the US FDA is very active in policing the GMP regulations. We receive copies of notifications of non-compliance and rarely does a week go by where a manufacturer is not issue a non-compliance notice with a demand for rectification.
This will be enough for today. My next post will start on the manufacturing process. There are three vital components needed to ensure that supplements are of high quality and effective.1. The Formulation. This is a very complex process and will not be addressed at this stage as the methods that we follow are commercially sensitive.
2. The selection of ingredients. This is critical and will make or break a supplement. I will explain not so much as to how they are selected but rather what is done to ensure that what is selected is what we get and use.
3. The manufacturing process itself which guarantees that the supplement contains what is says on the label.