Product traceability with the understanding of Lot and Serial Number

Product traceability with the understanding of Lot and Serial Number

As a wholesale distributor in the changing pharmaceutical Industry, you must be aware of the DSCSA’s November 2023 deadline. Before the deadline arrives, you must be ready for some of the specific requirements. You now have a lot of questions about why you need to make specific modifications. So, if you understand why the requirements were put in place, the only way to locate software that can help you meet those needs is to understand why they were put in place in the first place. We’ll explain product traceability, why we need to track a lot, and serial numbers as if we’re already tracking lot numbers, which tell us a lot.

What Is a Lot Number?

Lot tracking helps your business with product traceability to keep track of your customers whether they received their product or not and when they got it. Also, you can track the date of purchase from the supplier and from which supplier you purchased. It allows you to track an individual group of products (or shipment) from your supplier to your warehouse and then ultimately to your customer. Lot tracking is a core component in achieving FDA compliance for many businesses.

MetaPharma offers Lot tracking functionality as part of an all-in-one inventory and accounting ERP solution built on Microsoft Dynamics 365 Business Central. This feature of MetaPharma also allows you to perform lot costing – tracking actual costs instead of FIFO or average.

It simplifies the process in determining:

  • Which batches of medications are ready for purchase
  • Expired batches and, if necessary
  • Which batches of medication need to recall

What Is a Serial Number?

Lot number identifies an entire batch of products that were made, a serial number identifies the smallest individual saleable unit. The purpose of a serial number is to be able to track each individual product or smallest individual saleable unit. MetaPharma stands alone in its pharma-specific ability to manage labeling and serialization. Also, as well as regulatory requirements and is very flexible to adapt to the various upcoming regulations.

Why there’s a need to Track Lot Numbers and Serial Numbers?

The DSCSA’s role is to provide requirements that will help to improve the traceability of items moving through the supply chain. Nowadays, as products are moving from B2B, it is simple to add banned product and make them appear as though it is part of a reasonable batch. Once these items are thrown into the mix, there is no way to track where that one product came from or how many were added into that batch. The DSCSA has implemented the requirement for serial numbers because it allows us to identify the subsets of each batch. With serialization, you will be able to track the movement of each individual saleable unit.

Benefits of Pharmaceutical ERP Software Solutions for Pharmaceutical Distributors:

  • Meeting Regulatory Requirements
  • Inventory Management
  • Distribution Management
  • Document Control and Management

For more information and a tailored demonstration, contact us today at Meta-Pharma.

Pharmaceutical Distributors: How Pharmaceutical ERP benefits Distributors?

Pharmaceutical Distributors: How Pharmaceutical ERP benefits Distributors? Managing a pharmaceutical company isn’t an easy task, as it’s one of the most complex and highly regulated industries. Whereas, pharma companies are compelled to alter their compliance practices to conform to changes in regulations and stringent anti-corruption laws. In this article, we will look at how Important is ERP software for pharmaceutical distributors. As with most other industries, pharmaceutical companies are also expected to continuously increase their productivity, streamline their operations and optimize their competitive advantages.

However, it’s not effective to oversee and handle this all manually. Rather, modern pharma companies are now deploying ERP systems to aid with processes such as sales functions, batch production, quality assurance, inventory control, and accounting.

Pharmaceutical Distributors

Pharmaceutical distributors play a middleman role between the manufacturers and patients. If the pharmaceutical distribution is interrupted or mismanaged then the manufacturers might not be able to deliver the pharma drugs to the patients and hospitals in a proper, secure and timely manner. This could put the patients’ lives at risk.

Role of Pharmaceutical Distributors

As logistics experts, distributors do not manufacture, prescribe or promote medicines. Distributors also do not make clinical decisions as to who should or should not receive medicine or what medicine is best for a particular patient. Getting a medicine starts with a prescription, and distributors help make sure that what your healthcare provider prescribes gets to your hospital, pharmacy, or other healthcare facilities safely, securely, and reliably.

ERP for Pharma Distributors

A pharmaceutical distributor, while still operating under state legislation, will not be as closely regulated as manufacturers and as there are plenty of solutions that will let you create a manufacturing record and trace product genealogy you will have a bit more room to choose the best solution for you. It means that we can now look at more agile and cloud-based ERP products, such as Dynamic365.

For example, Meta-Pharma with the integration of Dynamics 365 Business Central, a fully integrated Microsoft ERP Solution is considered a good choice for many mid-sized pharmaceutical distributors these days.

Benefits of Pharmaceutical ERP Software Solutions for Pharmaceutical Distributors:

  • Meeting Regulatory Requirements
  • Inventory Management
  • Distribution Management
  • Document Control and Management

For more information and a tailored demonstration contact us today at Meta-Pharma.

Top 4 challenges facing by Pharmaceutical Supply Chain

Top 4 challenges facing by Pharmaceutical Supply Chain

Pharmaceutical distributors and wholesalers form an important link between drug manufacturers and hospitals, pharmacies, and other pharmaceutical institutions. The relations between the drug manufacturers, the distributors, and the end customers are complex and taken with some of the basic features of the pharmaceutical supply chain introduce a number of challenges for ERP systems.

Here are four of the most significant challenges

Lack of Transparency

One of the most common supply chain issues in the pharmaceutical industry is the difficulty in tracing problems to their source. Whenever pharmaceuticals arrive in a very unsuitable condition for human consumption, or an imitation drug gets into the shipment, or prices rise for no obvious reason.

Digitization

The digitization of documentation and standardization across industry platforms, digital signatures for regulatory documents, smart contracts, blockchain, and automation. The main challenge for pharmaceutical industries is the way to deliver changes securely, enhancing data security to help in post Covid19 work environments. And how to track conversion and reinvention of supply chain tools and techniques for continuous improvement within the digital world.

Compliance and regulations

The pharmaceutical supply chain already has to observe the latest Good Distribution Practice. But regulations are in constant change. Increasingly companies will need to organize their own internal control and management of customs and their supply chains in a better way, improving compliance to a new level.

Developing patient-centric pharmaceutical industry supply chains

With Meta-Pharma’s digital supply network, pharmaceutical manufacturers, health systems, and other stakeholders in the pharmaceutical industry supply chain get the granular end-to-end supply chain visibility and collaborative tools they need to create patient-centric supply chains. Healthcare providers are increasingly shifting far away from a one-size-fits-all approach in favor of personalized medicines, including next-generation cell and gene therapies, to boost patient outcomes.

In the event that you think about the current situation of the pharma industry, it is important to have an ERP system installed in the business environment. It helps in managing inventory, distribution, and manufacturing processes. Also, it streamlines the business operations of a pharmaceutical company. Meta-Pharma is one of the best ERP software solutions for pharmaceutical manufacturers and distributors. Also, it ensures growth in productivity and simplification of operations to enhance profit generation.

For more information about Pharmaceutical ERP and to know how to implement it contact us at Meta-Pharma.

How Pharmaceutical ERP helps Distributors to manage Scheduled Drugs

Scheduled Drugs

One of the most important challenges for wholesale distribution businesses within the pharmaceutical industry is managing Scheduled Drugs, Limits, and Licenses. To control these requirements, many small and start-up pharmaceutical wholesale distributors use manual processes and spreadsheets, but this is often a really time-consuming process and prone to human error, a significant concern for pharma businesses where violations can cause huge fines and therefore the loss of your license to buy and sell the product.

Rather than it’s best to find an ERP software solution that will help to manage Schedules and Limits. Additionally, to all the other regulatory requirements within the pharmaceutical world like Suspicious Order Monitoring, Lot Tracking, and more. Basically, this ERP software will also be able to handle all your operational requirements including purchasing, accounting, financials, and warehouse management.

Overview of Scheduled Drugs

In the US, all drugs, substances, and certain chemicals used to make drugs are classified into 5 distinct categories. These Schedules are supported on the drugs’ acceptable medical use and therefore the drug’s abuse or dependency (addiction) potential. There are 5 categories (Schedules I through V) starting with Schedule I drugs which have a high potential for abuse and may cause severe psychological dependence, to Schedule V drugs which have the lowest potential for abuse. Common examples of drugs found under each Schedule are as follows:

Schedule I DRUGS:

Some familiar drugs assigned a schedule 1 class include:

  • Ecstasy
  • Heroin
  • LSD
  • Marijuana
  • Peyote

Schedule II DRUGS:

Some familiar drugs in the schedule 2 class include:

  • Cocaine
  • Morphine
  • Hydrocodone (Vicodin)
  • Meperidine (Demerol)
  • Methadone
  • Methamphetamine

Schedule III DRUGS:

  • Ketamine
  • Anabolic steroids
  • Buprenorphine (Suboxone)
  • Codeine and hydrocodone products mixed with aspirin or acetaminophen

Schedule IV DRUGS:

  • Ativan
  • Ambien
  • Clonazepam
  • Valium

Schedule V DRUGS:

  • Robitussin
  • Lyrica
  • Lomotil

While the DEA will assign all drugs a Schedule, these Schedules can be changed later and every state can prefer to change the Schedule of a product, as long as it’s never lesser than the Schedule assigned by the DEA. Some produce other specific regulations around drug Schedules. For instance, some states require that any distributor wishing to sell Scheduled drugs in that state must have its “NABP Drug Distributor Accreditation. Having this accreditation is similar to being ISO Certified but in the pharmaceutical industry.

Managing Scheduled Drugs with Pharma ERP

To help simplify drug inventory management, Meta-Pharma (Pharmaceutical ERP) provides many great features in our Pharmaceutical ERP software to maintain accurate information and meet regulations. For pharmaceutical distributors dealing with Scheduled products, Meta-Pharma (Pharmaceutical ERP) ERP allows you to.

  • Allot Schedules for both DEA/Federal and States (as applicable) to each product/NDC
  • Allot Licenses to each customer ship-to location with expiration dates, track State License information if applicable, and record all associated Schedules the customer can purchase under the specified Licenses
  • Inform the software used when a customer’s License is close to its expiration
  • If a user changes the ship-to location for an order, Meta-Pharma (Pharmaceutical ERP) performs a re-calculation to determine if the new ship-to has an acceptable License and if not, the system removes the products from the Sales Order. This includes Sales Orders coming from Meta-Pharma’s B2B Online Order Portal which gets automatically re-calculated to ensure active Licenses each time.

To further verify license information. Meta-Pharma performs an acceptable License check every time a process is to perform a Sales Order.

As you can see, using Pharmaceutical ERP makes it nearly impossible to violate Schedule and Limit regulations when it comes to selling products to customers. This is just one example of how Meta-Pharma (Pharmaceutical ERP) ERP helps pharmaceutical distributors manage inventory and sell products, without having to manually track and worry about meeting regulations. These pharmaceutical features are just a set of tools available as part of Meta-Pharma (Pharmaceutical ERP)’s full ERP solution.

For more information about the Pharmaceutical ERP solution and a tailored demonstration contact us at Meta-Pharma.

How to manage your Inventory between your Pharmaceutical Distribution and 3PL

Manage your Inventory between your Pharmaceutical Distribution and 3PL

Moving with a 3PL (third-party logistics) provider model is common practice as businesses seek to exploit value throughout the supply chain. Instead of handling warehouse space, they use to pay a 3PL to handle the pick, pack, receipt, and shipping of product on their behalf. By doing this, the manufacturer ships products directly to the 3PL where orders are then fulfilled on behalf of the Wholesaler or Pharmaceutical Distributors.

This technique is basically for SMEs who do not wish to incur the costs associated with managing and staffing warehouse space, and for businesses that sell across the country and can benefit from multiple locations strategically placed. Before you decide on a 3PL partner, you need to consider all of the features of pharmaceutical ERP software. Below we explore how a Pharmaceutical ERP plays an important role and automates your business processes.

Pharmaceutical products require specialized procedures for their receipt, storage, handling, and distribution to their final destination.  Meta-Pharma, an ERP Solution for Pharmaceuticals Industry combines years of experience with a technologically advanced infrastructure for a sense of confidence and commitment that clients rely on and appreciate for the needs of pharmaceutical warehouse and distribution.

Meta-Pharma and Automated Processes

MetaPharma is an ERP Solution for Pharmaceuticals Industry built on Microsoft Dynamics 365 Business Central. It includes robust accounting and inventory management features and advanced functionality. Which work for traceability, lot tracking, regulatory compliance with the DEA, FDA, and DSCSA, and warehouse management. These features work together to automate processes and grow your business, increase transparency, and aid in regulatory compliance.

Meta-Pharma is an ERP Solution for Pharmaceuticals that can integrate with the systems used by your 3PL partners. Just like you need a solution to manage your daily business operations. Meta-Pharma with 3PL provides more chances for automation so that it can easily eliminate manual processes and the risk of human error.

Basically, it can be go through EDI, this integration allows your system to connect directly to the system of each of your 3PL partners. It means that instead of manually sending and receiving information and then manually updating your software, the systems can directly exchange information with one another, and then automatically update data and status’.

Value-Added Solution for Pharmaceutical Distribution

As you can see, integrating your Pharmaceutical ERP system with the software used by your 3PL partners is a much more efficient way of doing business. And, when you compare the costs and time associated with this, you may be happy to find that there is a clear case for electronically exchanging data. Especially, if you have to do a lot of transactions and a high order volume then it must be a better ERP solution for your Pharmaceutical Distribution business.

For more information and a tailored demonstration contact us at Meta-Pharma.

Why Pharmaceutical Manufacturing Businesses need ERP Software?

Efficient business processes, centralized management, quick decision-making, and clear analytics have become essential for any business to grow in the modern-day scenario. Each industry has its own reasons for implementing suitable ERP software. Whereas, ERP for Pharma Industry not only enables the consolidation and integration of pharmaceutical manufacturing processes across multiple units but also helps businesses to keep track of operations across the organization.

ERP-Software

MetaPharma, an Advanced Pharmaceutical ERP solution helps businesses in organizing their procurement processes, while reducing production and delivery time. Also, it helps manufacturers to be in compliance with cGMP requirements, in addition to providing a simple and cost-efficient process model. Being an ERP for Pharmaceuticals Industry, it understands formulation management requirements and integrates with your operations to provide real-time information.

Important Features of ERP software for Pharma Industry

  • Mobile Warehousing Management
  • DSCSA Track & Trace Compliant
  • CSOS and ARCOS
  • Quality Control
  • Orange Books
  • Executive Dashboard
  • Serialization Lot and Serial Number Traceability
  • Bill of Materials

Benefits of ERP Software in Pharmaceutical Manufacturing

MetaPharma, Pharmaceutical ERP system offers the following benefits:

  • ERP systems for Pharmaceutical Manufacturing ensure absolute compliance to the stringent regulations
  • Eliminate risk by delivering safer products of superior quality at the right price and right time
  • Introduce new products to market faster and cheaper than competitors
  • Real-time batch monitoring to make accurate business decisions
  • ERP software for the Pharma Industry help maintain formula secrecy
  • Respond quickly to customer demands
  • Smoothen operational process flow and enhance profits
  • Enhance the quality, consistency, and speed to deliver drugs to market
  • Control costs through reduced wastage, optimum material utilization, and inventory management
  • Pharma ERP software offer end-to-end bi-directional traceability, from the raw material to the finished product

This way, ERP software for Pharmaceuticals helps manufacturers streamline their entire operations and take a proactive informed decisions to outlast the competition.

For more information and a tailored demonstration contact us at MetaPharma.