Reference: softwareadvice.com

Buyer's Guide

by Lisa Hedges,

Content Analyst 

Last Updated: September 26, 2017 

Pharmaceutical manufacturers must contend with the conflicting requirements for complying with regulations from up to a half dozen federal agencies—with the need to maintain security, particularly during the development and testing phases. And then they have to put out consistent, quality product at the end of the day. While large, multi-billion dollar firms dominate the headlines, there are still a large number of smaller firms that make either a single pharmaceutical, ingredients for other manufacturers or specialize in medications with expired patents.

What Is Pharmaceutical Manufacturing Software?

Three of the most critical features companies are looking for in their pharmaceutical manufacturers software are:

• Inventory management: Since pharmaceutical ingredients and products are often controlled substances and must be secured, you can imagine the importance of a detailed inventory system for tracking these controlled substances. Substances used in the process also often have limited shelf lives. As such, they need to be rotated and used in a timely fashion.

• Production management/quality assurance: Production management must include recipe scaling for different batch sizes. Batch tracking, again for both ingredients and products, is mandated as part of recall management.

• Regulatory compliance: There’s a ton of regulatory compliance pharma manufacturers have to wade through. Not only must the shipping be documented, but disposal must be secure, documented and non-polluting. Even manufacturing start-up is regulated for some compounds. New and updated pharmaceutical manufacturing systems should support the FDA’s process analytical technology (PAT) initiative.

In addition to these three critical capabilities, most pharmaceutical management systems also offer some forms of fulfillment system that addresses both the security and shipping labeling aspects, both of which are stricter than general fulfillment systems.

Accounts receivable is standard except that the sums involved can be in the millions of dollars and for some products the customers must be positively identified. Payroll and personnel are again standard, as are general ledger and accounts payable.

If pharmaceutical manufacturing operations are part of a parent firm, they are likely to be using part of an organizational enterprise resource planning (ERP) system. Small and medium firms may use stand-alone accounting modules but are more likely to use manufacturing-specific systems. Most manufacturers use premises-based systems, but security is more of a driver than is cost.

Common Features of Pharmaceutical Manufacturing Software

Pharmaceutical manufacturers should examine the following functions while considering their unique requirements:

Formulation management and batch sizing    The system should include formulation management, including ingredient substitution and batch scaling. Advanced systems can size batches to quantities of ingredients in stock. The system should provide for formulations of different strengths.

Available to promise, capable to promise    Available to promise (ATP) and capable to promise (CTP) are measures of manufacturing capacity. The system should calculate the ATP and CTP for any stock item, accounting for ingredients on hand and any work in process.

Lot tracing and recall management    Each lot must be identified and tracked. The ingredients of each batch must be tied to their individual batch number as well.

Recall management    Recalls are initiated for two reasons. First, a problem in the process causes a product to become tainted or contaminated. Second, an ingredient is tainted or contaminated. In either case, the system needs to identify all of the affected batches and the customers that received those batches.

Hazard Analysis Critical Control Points (HACCP) compliance    The system should support reporting for Hazard Analysis Critical Control Points (HACCP), in accordance with HACCP Principle 7: “Establish record-keeping and documentation procedures.”

FDA compliance    The FDA is empowered to regulate standard and homeopathic pharmaceuticals; the standards for labeling are similar but have unique differences. The system should correctly label standard and homeopathic products as necessary.

Drug Enforcement Agency (DEA) compliance    If the pharmaceutical manufacturer makes products or uses ingredients regulated under the Controlled Substances Act, it is subject to oversight from the DEA. The system should document compliance with the act and have access to a current database of controlled substances, regulated chemicals and analogues.

Environmental Protection Agency (EPA) compliance    If the pharmaceutical manufacturer makes or uses products listed under the Toxic Substance Control Act, the substance may be regulated by the EPA. The system should maintain all compliant records as well as preparing a pre-manufacture notice before a new compound is created.

Quality assurance    The system should support quality assurance (QA) testing. The protocols should be documented and implemented through the system. The QA system should randomly identify samples for testing and compare test results against norms. Advanced systems will feature dashboards that will alertadministrators to problems with quality.

Process analytical technology support    The system should identify critical process parameters and define their affect on critical quality attributes as part of quality assurance testing.

Code of Federal Regulations 21 Part 11 compliance    Strictly speaking, no software package can be 21 CFR Part 11 compliant because the rule stipulates administrative and procedural controls as well as technical implementation for electronic and hybrid record keeping. However, it can support 21 CFR Part 11 by completely implementing the technical requirements.

Current Good Manufacturing Practice (cGMP) compliance    cGMP compliance is required for many regulatory agencies at the state and federal levels as well as for insurance purposes. The system should produce required compliance reports.

Yield variances    The system should track actual yield versus expected yield for each batch. The system should report excessive variance based on user-defined thresholds and indicate if variances are so large that regulating agencies should be notified.

Packing & drumming    The inventory system must be able to value and price items in different container sizes. It must also identify or generate suitable labels for containers.

Inventory storage planning    Some pharmaceuticals require a specific storage environment. The inventory system and receiving systems should notify workers about any special requirements.

Expiration tracking    Both pharmaceutical ingredients and pharmaceutical products can have limited shelf lives. The system needs to track expired and close-to-end-of-life inventory.

Shipping    Many pharmaceuticals have restrictions on shipping either via USPS or common carrier. In some cases, the contents of a package may not be listed on outside labeling. The system should identify any special requirements and produce appropriate shipping labels.

Best practice in pharma supply chain management

Reference: pharmaphorum.com

Patrick LemoineJanuary 23, 2017

Pharma needs to utilise the latest technology to maintain agility, and hence competitiveness, across the supply chain, says Patrick Lemoine.

The pharmaceutical industry has been one of the best-performing industries of the past decades with pharma companies excelling in many disciplines (research and development, manufacturing, sales and marketing) while maintaining the highest safety and quality standards. As a result, both sales and profits have risen more than in most other industries.

Yet, in recent years, the industry has been facing significant challenges:

• The competitive intensity has significantly increased with the fast rise of generics.

• Overall, the product portfolio has grown more complex, with more niche products for new markets.

• For over-the-counter (OTC) products, large drugstore chains are imposing the same high standards (e.g. on-shelf availability, promotions) as they do to consumer product companies.

• Healthcare providers and government reforms continue to put strong downward pressure on prices.

• Quality regulations, the rise of counterfeited drugs and the serialisation mandate are forcing pharma companies to make their supply chains more robust to ensure full traceability.

All of this is putting new demands on the supply chain to help address these challenges and bring products to market cost-effectively and at the required service level.

In addition, pharma companies are increasingly relying on a global network of R&D partners, suppliers, logistics providers and contract manufacturing organisations (CMOs) to develop, test, produce, ship and distribute their products. Using specialised outsourcing partners for key supply chain activities provides companies with significant cost and flexibility benefits. Few large pharma companies are not outsourcing to some degree.

However, this new outsourced model brings additional complexity. How do you run a supply chain tightly that is increasingly virtual? How do you run an outsourced supply chain when the in-house enterprise resource planning (ERP) system(s) only see(s) what is inside the four walls of the company? How do you manage workflows that involve exchanging information with outside parties across the multiple tiers of your supply chain?

Redefining supply chain management

Following other industries, like high-tech and consumer goods, pharma companies need to focus on the following five initiatives:

Connect and collaborate using a business network. A digital business network is the foundation of a multi-enterprise supply chain, connecting all outside supply chain partners electronically via the cloud. Unlike the old model of creating point-to-point connections, this is a true, multi-tier network – connecting everyone, like the Internet does, and allowing all partners to work in sync. This enables both end-to-end visibility and the collaboration needed to support business interactions among the different actors. Such a network is like an ERP system, but for the entire supply chain. Without such a platform, it is almost impossible to get the level of real-time visibility and coordination among all supply chain partners that is needed.

Understand true demand. Demand forecasts are only an educated guess of what future demand will be. For their OTC business, the most innovative pharma companies are following consumer products companies: capturing vast amounts of demand-related information which is then fed into sophisticated demand sensing solutions to better predict true demand. This means going all the way to point-of-sale (POS) data or even using signals like weather forecasts or flu trends via social media. This improved demand picture is then propagated to all supply chain partners, ensuring that the pharma company, suppliers and CMOs are all aligned. Demand sensing brings significantly higher on-shelf availability and lower inventories.

Control the quality at the CMOs. Pharma companies need to ensure end-to-end traceability. As external parties, such as CMOs, are increasingly involved, pharma must have visibility into partners’ manufacturing operations to track product quality across the multi-tier, multi-enterprise supply chain. This means connecting to their CMO’s manufacturing execution systems (MES) to capture relevant data at all stages of production. This provides very granular factory transaction visibility to track material flows, lot genealogy, processing steps and associated parameters, such as yields or test results – critical information to ensure traceability. This is a requirement for any serialisation initiative.

Quickly re-plan across the network. Another requirement is to detect and respond quickly to changes in the demand and supply picture. With business networks, companies can see the end-to-end supply chain, not only in-house operations. However, traditional planning systems lack the fast problem resolution and decision-support capabilities required to manage trade-offs and suggest alternative scenarios offered by state-of-the-art planning applications. These tools allow rapid evaluation of new information – be it a supply disruption or an unexpected demand change – and easily compare alternative plans to select the best option. The new plan is then shared with all supply chain partners via the business network.

Better manage distribution. Pharma companies are increasingly relying on external partners for transportation, warehousing and other value-added services. Ensuring product availability means tightly managing distribution partners. This includes getting complete downstream inventory visibility and sophisticated inventory strategies. Proactive management means allocating to the different channels to optimally and profitably deliver the right products to the right customers and make reliable delivery commitments. This is key when competing for shelf space at drugstore chains and pharmacies.

Supply chain operating network

New strategies use the experience of consumer product companies but take into account the specifics of the pharma industry. A cloud-based network to enable end-to-end visibility and collaboration among supply chain partners, combined with dedicated decision-support applications that leverage the data in this network is the best set-up. The benefits are substantial:

• Up-to-date, end-to-end supply chain visibility – ‘one version of the truth’ shared across all partners

• Full quality control of CMOs – as required for traceability and serialisation

• Higher on-shelf availability, generally with lower inventories

• Through smarter channel allocations, better margins and ultimately higher market share

The early adopters are already capturing these benefits, putting themselves ahead of their peers.

About the author:

As VP Product Marketing, Patrick Lemoine is in charge of E2open’s product positioning and company messaging. He has more than 20 years of supply chain experience, as well as a deep knowledge of the high-tech and automotive industries.

He started his career as a consultant with McKinsey and Co and spent the last 15 years in the enterprise software space with companies such as i2, LogicTools, and SAP.

He holds an MBA from Stanford University.