6 tips for regulatory compliance in logistics
pharmafile | November 2, 2010 | Feature | Manufacturing and Production, Research and Development |Â Â Biocair, GMP, International Council for Harmonisation, pharma logistics, regulatory complianceÂ
Regulation! Regulation! Regulation! Never has our business been more highly regulated than it is today. Seemingly, rules change every day. So how are we supposed to cope?
It can be really difficult, and this brings me to my first point. One of the key issues today is the impact of unconscious ignorance. In other words, not being aware of all the regulations that affect the way we want to do business or run our supply chains.
How many times have you set something up to ship believing that you have taken care of all regulatory requirements, only to find that the shipment ends up being delayed with all the consequential issues and costs associated with that disruption? Judging by the many conversations I have, this type of thing happens a lot.
Because there are few global standards, with each regime applying its own version of control in each area, it gets very complicated. It’s hard enough dealing with what you know without considering what you might not know! Even a widely used and understood area like GMP can be really confusing.
Initially intended as a set of guidelines, GMP can be much more or less than that.
The World Health Organization’s version of GMP is used widely by pharmaceutical regulators and the industry itself in many locations, but some countries have taken it further, producing their own versions. Other’s are linked to the International Council for Harmonisation version published originally in 1999. So whose is right?
The short answer is that they all are. So how can we cope with these things on a daily basis? We can’t all be experts in every regulated area, besides which, we have our main jobs to do.
Here are some tips to ease the burden and enable you to sleep at night:
1. Learn what you can. Identify the key regulatory areas and gain a working knowledge for the locations and regimes you are working with regularly. Knowing something will enable you to avoid being misled and making costly errors. Not wanting to be an expert in every area, the most important thing to know is where to go when you need advice or help.
2. The little black book. You might not be an expert but they do exist, so make sure that you know who and where they are. Link up with them and where possible work with them. This is where networking can really pay dividends.
3. Make sure your service partners have the ability to support you fully in compliance matters. There’s nothing worse than hitting an issue only to be left to sort it out as best you can, often 1,000s of miles from where you work and often in a different language.
4. When choosing your partners make sure that regulatory compliance capability is something that you are looking for and demanding. Ideally your partners should have a long experience of successfully dealing with such matters and a high level of expertise and knowledge. Most importantly of all, they should have a track record of delivering results.
5. Don’t assume that what you know to be correct today will be correct tomorrow. It will change, and most definitely don’t assume that what is right in one location will be right in another, no matter how closely they are linked, even in the same country.
6. Use your network, web and publications to stay as current as possible. A few minutes a month could save you hours, days or even in some cases weeks of disruption and stress.
The other issue I come across regularly is that rules when they exist are nearly always open to interpretation.
Each enforcement officer can and may have their own idea of the intent of a rule, or meaning of a phrase. Expect this to play a part in your supply chain and you won’t be disappointed. No one is doing anything wrong, just seeing things in a different way. This explains how a shipment can cross a checkpoint one week without issue, only to fail the next, even when the rule has remained the same.
This is clearly frustrating, but it happens a lot. One of the secrets here is to work with people who understand both your frustration and that this happens.
Generally speaking they will be the same people who, because they expect this, are ready to jump in and help to resolve the issue pro-actively.
Yes it can be done. The right intervention, carried out in the right way and at the right time can really make a difference.
Another secret is to prepare carefully for a shipment, even if it’s one you do regularly – as discussed above, regulations can change on a daily basis.
For a shipment you haven’t made before, find out what the issues might be and try to reconcile them before you ship; a good service partner should be willing to help with this.
This can be frustrating but whatever time is spent making sure a shipment is compliant, will save significant time and money further on down the line.
Compliance isn’t easy and as the trading world widens it is unlikely to get any easier.
Andy King is the managing director at Biocair.
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