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Pharmaceutical Manufacturing Software: Challenges, Opportunities & Selection Tips

pharma manufacturing software

The pharmaceutical manufacturing industry has been rapidly evolving. The manufacturers of drugs, vaccinations, and medical devices, among others, face numerous business challenges, which include stringent regulatory requirements, radical healthcare reforms, volatile market trends, etc. Then there are challenges pertaining to traceability, and quality control.

There’s also the stiffening global competition, and the challenge of dealing with an informed & demanding consumer base, which has a whole new set of demands driven by the recent changes around the world on different fronts such as health and wellness, lifestyle, safety, preferences, sustainability and technology.

The constantly changing market conditions, and the ever-growing demand for new and enhanced pharmaceutical products has put a lot of pressure on pharmaceutical manufacturers, who need to be ready to react quickly and flexibly to meet the demand for production in huge quantities, and remain competitive.

Impact of COVID-19

A lot has happened around the world in past one year ever since the first case of COVID-19 pandemic was reported, followed by the lockdown. China, being the purported fountainhead of the COVID-19 pandemic, and also the major center of medicinal raw material production, derailed the global supply chain, and affected the pharmaceutical manufacturing operations around the world.

Check this- Around 70 percent of the pharma raw materials are imported from China. Furthermore, more than 75 percent of businesses have “one or more direct or Tier 1 supplier,” from China, and 938 of the Fortune 1000 companies have Tier 2 suppliers there. These stats throw light on how pharma manufacturers world over suffered immediately after the outbreak of COVID-19.

In order to adapt to these changing trends, and negate the business challenges along with the impact of Corona virus pandemic, pharmaceutical manufacturers need to invest in a technological tool such as an enterprise resource planning (ERP) software. Through this blog, let’s understand in detail the challenges and opportunities for pharma manufacturers, and how to select an ERP that can aid in these challenges:

Challenges and opportunities

Challenge- Supply chain disruption:

As mentioned in the above paragraphs, COVID-19, and the subsequent efforts to control it caused significant disruption to supply chains around the world, predominantly due to pharma manufacturers’ heavy reliance on China for a particular ingredient or ingredients. The key for them is to make their supply chain resilient so as to meet future crisis with confidence.

Opportunity

During such unprecedented times, the pharma manufacturers need an ERP more than ever. Using it, the manufacturers can maintain a list of multiple approved suppliers, who can easily chip in when the primary supplier breaks down, and is unable to meet procurement requirements. ERP ensures that these are the vendors who have ‘supplier verification’, and offer ingredients that meet quality & consistency standards.

Challenge- Keeping up with regulatory updates:

The pharmaceutical regulatory landscape is ever-evolving. Furthermore, during the pandemic, the regulatory bodies as well as governments around the globe have revised regulatory guidelines for the products, as well as conducting operations at the plant. Keeping up with these guidelines is a challenge for the pharma manufacturers.

Opportunity

A pharma manufacturing software ensures that the pharma businesses meet all the local and global regulatory requirements such as the FDA CFR 21 Part 11, and also other industry, and environmental requirements. Its specific features such as workflows, approval controls, and audit trails help create a business model where in the businesses stay complaint and adhere to all the rules and regulations.

Challenge- Helping with Quality Control & traceability:

The market demands compel pharmaceutical manufacturers to create safe and top-quality products, and for that, they need the capability to quickly identify when, where, and what goes wrong at their manufacturing plant.

Opportunity

A pharma manufacturing software with Quality Control (QC) functionality allows the manufacturers to set quality checks and quality statuses at different stages, thus ensuring the movement is as per cGMP and only the appropriate materials are sent for approvals, while the inappropriate ones are rejected and sent for quarantine. Also, its bi-directional traceability functionality allows tracing ingredients right from procurement to final sale, enabling swift product recalls.

Challenge- Deal with the rising costs:

In the post-COVID-19 world, with raw materials in limited supply, their prices have sky-rocketed exponentially. Besides, shipping costs too have gone up in most countries. With sales being on the lower side in the initial part of the lockdown, the cash flow also took a hit. Dealing with these challenges is yet another headache for the pharma manufacturers.

Opportunity

A pharmaceutical manufacturing software helps reduce labor costs by managing complete labor information such as skill-set, shift timings, assigned tasks, and more, and by improving overall process flow. Pharmaceutical software also manages efficient & effective deployment of a pharma manufacturer’s resources, keeping the costs under check, and also creating top-quality products at compelling prices.

Challenge- R&D & commercialization support

Extensive clinical trials, rigorous sample testing, and long product life cycles, are an integral part of the pharmaceutical manufacturing process. However, managing these samples and keeping their manual record could lead to costly errors. Also, a lot goes into researching and developing a drug, getting its approval, and preparing for its market launch.

Opportunity

A pharmaceutical software allows maintaining records of samples along with their trial histories in one centralized database, which can be accessed by anybody, at any time, especially for reference and audit purpose. Moreover, a pharmaceutical software provides support to the entire new product development lifecycle, and to all the processes such as manufacturing, sales & marketing, production planning, et al.

Challenge- E-commerce support:

With changing times, the consumption and buying patterns of the consumers have also changed, as the pharma companies (both B2C and B2B) are beginning to break into the e-commerce space. COVID-19 has further given a thrust to this situation. In order to successfully deliver these critical products, pharma manufacturers require flawless time and information management.

Opportunities

One way the pharma manufacturers can keep pace with these innovations and beat the challenges that come along with them is by integrating their online store by their pharmaceutical software. This allows them to oversee important product data in their web store, and have complete control over their online operations. Besides, opening up to a whole new set of customers remains a key benefit of the same.

ERP selection tips

If you have made up your mind of purchasing a pharmaceutical manufacturing software by now, this part of the blog can help you take the final few steps, which are the most critical ones. Read these simple steps to get started with your ERP selection process:

Requirement analysis: To begin with, you must define your business requirements clearly. This includes identifying the pain areas of the business which need to be addressed. You also need to analyze your business financials to reach to a budget for the project. This is the most important step, as it can make or break the entire project.

Shortlisting: Once you have your requirements ready, you can accordingly prepare a shortlist of four to five prospective ERP vendors that offer solutions targeting your business requirements.

Comparison: Once the shortlist is ready, the next step is to compare the options based on their performance in different requirements. Demo sessions and trial accesses can be handy in this regard.

Final selection: Take into account certain important factors such as training & post-implementation support, upgrades & data security, and system scalability, etc., before making the final decision.

Once you follow these four steps, you are bound to pick the right pharmaceutical manufacturing software for your business.

Closing thoughts

Given the current scenario, it has become all the more important for the pharmaceutical manufacturers to maintain highest quality standards across all processes. To achieve this objective, a pharma manufacturing software is a must-have. It provides accurate actionable data, centralizes management, fastens decision making, streamlines operations, and maximizes efficiency.

Furthermore, such a system can also help improve the manufacturing processes in general, along with patient safety, quality, and hygiene standards. One such system is BatchMaster ERP for Pharmaceuticals. To know more about it, and whether it serves your pharma manufacturing business or not, visit our website, or connect with our experts to schedule a free demo.

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Author

Sanjay Panjwani

I am Managing Director at BatchMaster Software India Pvt. Ltd., a leading vendor of ERP solutions in all the 7 continents. With over 30 years of presence in the ERP market & 1500+ customers situated all over the globe, BatchMaster is a mature organization of 200 plus employees.

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