As many of you are aware, there are big regulatory changes happening in the EU with regards to Good Distribution Practices in the Pharmaceutical Industry. It all started back in 2011 when the EU posted revised commission guidelines on Good Distribution Practice of Medicinal Products for Human Use. They determined that the previously documented guidelines from 1994 were no longer adequate and they needed to be revised.
Topics: process improvement
If you are a consultant, you know that you only know the answers to the questions that you ask. If questions don't get asked, you can't understand all the things that need to be fixed. This makes it hard to scope projects, know how much to bill, and make sure that you don't loose sight of the end goal. The best way to uncover everything you need to know is to start each engagement with a consistent assessment. A good assessment will:
Topics: online assessments
A Gap Analysis Uncovers Areas for Improvement
Distribution Practice Gaps: Where to Start?
Due to new government regulations, pharmaceutical and biotech firms are forced to improve the efficiency and security of their supply chains. The gaps in these distribution channels become clear, not only to the organizations but to the regulators as well. As these manufacturers focus their attention on the safety and security of their drugs from plant to patient, the ability to prioritize and close these gaps becomes more and more important.
The challenge lies in the ability to get a clear and complete picture of the supply chain. And, in many cases, organizations will use Business Process Assessments (BPA's) that are conducted at a point in time and they cover a defined operational and/or geographical scope of activity. But, there are limitations caused by BPA's:
These three flaws hinder an organizations ability to succesfully prioritize and close the gaps in their pharmaceutical supply chain.
Pharmaceutical companies have to protect their drugs. Today, drug companies react to damage, instead of trying to prevent them from being ruined. And, one of the easiest ways to do that is to understand everything that a drug goes through as it makes its way from plant to patient. If you understand where your drugs go, you can prevent any potential problems. This way, you'll never have a shipment of newly approved and released drugs sitting on a tarmac in Arizona in August being ruined by the heat.
There are a couple of reasons why this is hard to do:
Life Sciences companies spend a lot of time and money producing the drugs that help save lives. But, much of that money is spent in the manufacturing process, what happens to the drugs once they leave the plant?
In the world of Pharma & Biotech, a lot of emphasis is placed on the quality of the manufacturing process. Obviously, it's an important part of the medical technology industry. Without proper manufacturing, these companies don't exist. But, how does the product, once it's so carefully manufactured get from the manufacturing facility to the patient? And, what if something happens along the way? How can Biotech and pharmaceutical companies and their insurance providers be confident that their products are safe and secure as they travel through complex distribution channels?