In the pharmaceutical industry, each raw material has its own history.
Go through a number of steps before an active ingredient goes down the production line or is added to a final product. All teams members in procurement, quality and manufacturing departments need to understand this process.
Failure to choose the right supplier, document or verify the materials can lead to compliance problems, delays or quality problems.
This is why traceability is one of the number one pharmaceutical procurement issues.
Often starts with a CAS Number: An example of this is something simple.
Finding a pharmaceutical raw material's CAS Number is a mere first step to finding the actual batch in a certified batch of a product that is traceable from that CAS Number. It involves supplier verification, documentation analysis, quality testing and full supply chain visibility.
Let's take a look on how this works.
CAS Number, Chemical Abstracts Service Number, a number which is assigned to a chemical substance.
Imagine that it's a fingerprint of a chemical.
For example, if a pharmaceutical buyer is seeking to buy a specific active ingredient can use the CAS Number to acquire the exact active needed.This resolves confusion due to various chemical names, trade names, or regional naming.
CAS Number, however, only indicates the identity of the material.
It doesn't tell you:
The actual traceability process starts once the substance is identified.
After the procurement material is identified, the procurement team starts looking for the suppliers.
This can be one of the most important steps in the sourcing process as all decisions that are made thereafter is dependent upon the quality and reliability of the supplier.
When choosing a pharma raw material supplier, the buyers consider the following things:
The aim is not to identify just any supplier who will supply the material. The result is to identify a supplier that can supply the material consistently, reliably and with complete transparency.
This is where supplier visibility comes in very handy.
If supplier information isn't available, procurement teams are required to make decisions without the clarity of knowledge regarding quality and compliance.
Documentation verification is the second step after identifying potential suppliers.
Documentation is evidence that a material has been produced under controlled conditions and has met specified requirements.
A few of the most critical documents are:
The Certificate of Analysis is very special since it contains data specific to a batch.
It typically includes:
Documentation from suppliers can be reviewed by procurement staff against in-house quality standards, before purchasing.
The step helps to lower the risk and increase confidence in supplier selection.
After the shipment reaches a manufacturing facility, the material goes into another level of traceability.
Supplier verification moves to material identification at this point.
All incoming materials are checked and notes are taken.
Typical activities include:
The material is then given internal-tracking data, which enables it to be tracked throughout its life cycle in the organization.
In this tracking process, a valuable link is established between the supplier's batch and the manufacturer's internal records.
This connectivity makes traceability much more difficult without it.
In order to be approved for use, a raw material must be received.
Pharmaceutical materials usually go through a quality evaluation process prior to production.
The aim of testing is to prove the material has the same properties as the supplier states and conforms to specific quality requirements.
Testing may include:
Quality teams conduct comparisons of laboratory results with the supplier documentation and the product specifications.
If it is acceptable to the requirements, then it can go on to be produced.
If problems are detected, the material could be returned or may need to be investigated further.
This step is one of the most critical points of the pharmaceutical traceability process.
Upon approval, the raw material is added to the manufacturing process.
At this point, traceability goes beyond the batch that the supplier provided.
Manufacturers track:
This results in a comprehensive traceability linking the supplier's material with the end product pharmaceuticals.
If it is found later, manufacturers can easily find out:
The affected raw material batch(s)
The visibility allows an organization to react to investigations, customer complaints and product recalls if needed.
The pharmaceutical supply chains are becoming global in nature.
Suppliers, manufacturers, testing laboratories, and logistics providers can be spread across a variety of countries for a single product.
With growing complexity in supply chains, visibility is becoming more difficult.
That's why traceability has become a top concern for procurement teams.
A good traceability assists the organisations:
Traceability is not considered to be a quality function only. It has become a strategic procurement need.
Quick retrieval of supplier information, batch records and sourcing information can benefit organisations ability to make informed procurement decisions.
Supplier information was fragmented in email, spreadsheets, filing systems and isolated databases traditionally.
It can be challenging to manage traceability in such circumstances.
Supplier records, documentation and sourcing information are typical things that procurement teams must spend a long time looking for.
Digital procurement platforms are aiding in this solution.
Running multiple systems means multiple systems, but organizations can enjoy unified sourcing environments that provide better visibility of the sourcing process.
Benefits include:
These features can offer pharmaceutical firms with a number of suppliers and thousands of raw materials a substantial increase in sourcing efficiency.
A pharma raw material marketplace is a single source for procurement teams to find and manage suppliers.
Buyers can find information about suppliers, product, and sourcing opportunities in one place instead of having to search through multiple channels.
This has a number of benefits.
Firstly, it makes suppliers more visible.
Second, it makes it easy to compare suppliers.
Third, it enables enhanced procurement decision making.
Most importantly, it helps procurement teams to lay a stronger foundation for sourcing prior to materials entering the supply chain.
The more robust the supplier selection process, the more traceable it will be along the material life cycle.
In the world of pharmaceutical procurement, traceability begins well before a material gets to the warehouse.
It starts at a supplier discovery.
ChemDmart enables pharmaceutical buyers and pharma raw material suppliers to easily connect through a dedicated B2B sourcing platform for Pharmaceutical and Chemical buyers.
ChemDmart offers access to supplier networks, sourcing opportunities, procurement intelligence and RFQ management tools, which helps organisations gain better visibility of suppliers and enhance sourcing efficiency.
From APIs, intermediates, excipients, specialty chemicals to industrial raw materials, centralized supplier information can help in making informed sourcing decisions.
The more effective sourcing is, the more robust the traceability.
The journey of a pharmaceutical raw material from a CAS Number to a certified batch is a journey of visibility, verification and control.
A CAS Number is a way to identify a substance, but much more is needed for true traceability. It demands a sure supply chain, authentic paperwork, quality testing, batch tracking, and complete transparency of the supply chain.
Pharmaceutical supply chains are getting longer and more complex and procurement teams are playing a greater role in traceability from the initial sourcing phase.
Those that take advantage of supplier visibility, supplier intelligence, and digital procurement will be better armed to manage risk, improve quality control, and increase supply chain trust.
Traceability doesn't start in manufacturing these days in the pharmaceutical world. The first is smarter procurement.
