Article 007 - Pharma Manufacturing and Distribution , a different lot .

You can send a CPG customer the wrong items and get away with it reasonably unscathed . But the same cannot be said for customers who order pharmaceutical goods . It’s a lucky day if they only sue for sending them the wrong goods , but if your mistakes cost people’s lives then you’re looking at much more severe consequences .

The Pharmaceutical distribution process is a different beast altogether . It’s a cycle of complex processes and tasks that require a high level of security with constant flow of information sharing . Visibility of the entire distribution flow down to its smallest components is also very critical to ensuring the quality of what’s being shipped out .

From raw materials to WIP and from FG to customer , there are various goods movements that need to be captured to comply with whole the set of existing and emerging government regulations that are put in place around ‘safety and efficacy’ to protect consumers .

If you are looking for a technology platform that is able to not only help optimize your pharma supply chain distribution by accelerating the circulation of goods while at the same time increase the precision of the deliveries , then you will have to look for systems that are able to cater for the following challenges / requirements that are specific to the pharma industry .

Traceability – Lot & Batch tracking

1. An effective method of tracking drugs / medication that have been delivered from a manufacturer .

2. An effective way to also identify counterfeit medications and remove them from the supply chain.

3. A ‘Lot’ ID is basically a tracking ID that can be applied to the raw materials (components that go into the manufacturing of medication , that come from a specific supplier) which is in turn tracked by another tracking ‘ID’ called a batch ID.

4. The Lot ID will also be tied to additional information like the UOMs being used , date of manufacture and date of expiry and other relevant information

5. The Batch ID , which can consist of several Lot IDs can also be tied to information related to date of manufacture , date of expiry , ideal temperature conditions for storage …etc .

6. Lot IDs and Batch IDs make the process of ‘product recalls ‘ much more faster and efficient . lot and Batch tracking allows the manufacturers and distributors to easily locate the recalled medication from anywhere within the manufacturing process as well as anywhere within their supply chain .

7. Once the defective Finished Goods Batch or Raw Material Lot is identified , the offending F.G or R.M can be put on ‘hold where it sits’ and not be allowed to move onto the next part of the process flow , EX: From R.M picking locations to WIP or From F.G picking locations to customer .

8. To comply with government regulations where a ‘Pedigree or ePedigree’ statement with the list of batches and lot codes used per batch are generated to passed on from manufacturer to anyone down stream from them like whole sale distributors , hospitals and pharmacies for tracking purposes

Serialization

1. Taking tracking IDs a step further by applying a tertiary tracking ID (a specialized serial number) to each individual medication /drug (usually done at packaging level) to track goods individually throughout the supply chain from manufacturer to patient / consumer .

2. Serialization came into the picture to make it even more easier for manufacturers and distributors to spot products that have been tampered with or that are counterfeit .

3. Unit level serialization requires 2D barcodes or GTIN barcodes to store information such as ,product origin, shelf life and batch number.

4. Things can get even more complicated when distributors need to further aggregate multiple child Serial numbers (usually by sealable unit – Box , Bottle ..etc) to a master serial number for more effective master packaging and shipping .

Conclussion:

The Pharma supply chain which has been plagued by counterfiet medication , adulteration shady marketing have been forced by both their consumers and government regulations to further ensure that their products are manufactured safely adhering to the highest quality standards and distributed correctly , cost effeftively in a timely fashion . And so they will have to adopt technological platforms that will allow them to do just that .