With its scope covering a whole lot of things such as drugs and vaccinations, and medical devices, among others, the huge and diverse pharmaceutical manufacturing industry has attained colossal proportions.
The industry is extremely sensitive in nature, given that its operators deal with critical life-saving medicines and equipment. And naturally so, the industry is one of the most highly regulated ones.
The manufacturers have to deal with conventional challenges such as strict regulatory requirements which are getting more stringent by the day, traceability and quality control challenges, cut-throat competition, unforeseeable market trends, and increasingly aware consumer etc. on a daily basis.
Amidst all this, the manufacturers strive to produce effective and reliable drugs and devices, for which they invariably look to evolve with changing times. They look to embrace technological innovations so as to improve their manufacturing processes in general, and many other things such as improving patient safety, quality, and hygiene standards etc.
In this quest, a pharmaceutical manufacturing software comes to their rescue, as it helps them impeccably link all the departments, and integrate all the internal processes. As a result, the pharmaceutical manufacturing businesses operate more efficiently and profitably.
If you are a pharmaceutical manufacturer, you ought to know more about this tool which acts as a panacea to the problems you face. So, in this blog, let’s take a look at 10 absolutely mind-numbing facts about the pharmaceutical manufacturing software:
1) It secures formulation: For the process manufacturers, i.e. the formula/recipe-based manufacturers, it is extremely important to get their drug formulation accurate. ERP implementation in pharmaceutical companies comes in handy in this regard, as its formulation module helps the manufacturers manage their formulas – which usually are developed after intense research and hard-work – comprehensively. Formula security, thus, is of paramount importance to them, knowing even slight modifications to the formula can have disastrous effects. An ERP system keeps a record of all the modifications saved, and immediately updates the concerned people about the changes, seeking their approval. Formulation module’s formula approval feature restricts the access to the formulas, allowing only the authorized to make changes.
2) It helps meet regulatory compliance: Meeting the industry, environmental, as well as regulatory requirements is a non-negotiable requisite for pharmaceutical manufacturers. And needless to say, it is impossible to be done manually. The manufacturers need an industry-specific manufacturing software which ensures that the business meets all the local, national, and international regulatory compliances such as the FDA CFR Part 11, cGMP, reporting and labeling and more. In addition, a pharmaceutical manufacturing software also helps create a business model which adheres to all the industry norms as well as best practices.
3) It helps with Quality Control & traceability: The pharmaceutical manufacturing industry has invariably struggled with the Quality Control issues, and there has always been a strong need for credible and reliable quality standards. A pharmaceutical ERP software, with its QC module, eliminates even the slightest of slip-ups and ensures conformance with expected results. It allows tracking of every raw material within the supply chain, right from receipt through finished product delivery. Well-defined QA and QC roles mean that only the appropriate materials are sent for approvals, while the inappropriate ones are rejected and sent for quarantine, returned or scraped. Also, the ERP system enables swift product recalls through its bi-directional traceability functionality.
4) It helps with supplier management: ERP implementation in pharmaceutical companies enables the manufacturers to procure raw materials from only the recognized suppliers who have the ‘Supplier Verification’. This way, only the high quality, and safe materials come into the system. A pharmaceutical manufacturing software checks for vendor recognition, and only accepts raw materials procured from the authorized vendors whose information is stored in the system. An alert is generated automatically if there’s any discrepancy or when the vendor certification is nearing expiry.
5) It helps maintain device history and MBRs: FDA guidelines make it mandatory for the pharmaceutical manufacturers to maintain device history or Manufacturing Batch Records (MBRs), which are essentially the written instructions for a specific manufacturing process for each unique formulation and batch size. It is compulsory for them to document everything, right from raw material testing to post-sale servicing, for a faster and smoother audit procedure. A pharmaceutical manufacturing software makes it possible. Post production, the entire data related to the production process is stored in the Batch Master Record (BMR), which can be compared to the MBR for audit purpose and also to see if there is any deviation. The deviations, if any, can be fixed through NC/CAPA.
6) It helps with sample management & clinical trials: Pharmaceutical manufacturing involves extensive clinical trials, rigorous sample testing, long product life cycles, etc. Keeping a record of all the samples, communication with the customer and the specified modifications manually can lead to costly errors, and is thus out of question. ERP implementation in pharmaceutical companies makes it convenient for manufacturers to manage such records and trial histories in a common database that can be accessed anytime, especially for reference use and audits.
7) It ensures data security: Just like for any other manufacturing business, data security is crucial for pharma manufacturers as well. Whether it’s regarding formulation, material substitution, sensitive reports or even the customer order details, data security is of paramount importance. Pharmaceutical manufacturing software boasts an array of security features such as access controls, data encryption, audit trails, and electronic signatures and passwords, among others.
8) It ensures production as per cGMP norms: A pharmaceutical manufacturing software ensures production is carried out as per the cGMP (Good Manufacturing Practice) norms. The complete material movement is controlled through lot statuses. Quality tests are applied at all major points of the supply chain right from material receipt from the vendor, its entry in the warehouse, issue to production, converted to intermediates or finished good and finally while shipping to production. This ensures only the right quality material is moving along the supply chain, hence following GMP.
9) It gives real-time access to information: In the pharma industry, changes may happen at a rapid rate. The companies must be equipped enough to respond to the changes on time, or else be prepared to lag behind the competitors. ERP implementation in pharmaceutical companies ensures that manufacturers get real-time access to critical information through powerful reporting tools. This way, the manufacturers can make the right decisions at the right time, and keep driving the business growth.
10) It provides commercialization support: The life of pharma manufacturers is pretty difficult. They work really hard to research and develop a drug, and even harder to get approval for the same. Once they do get the approval, the preparation for its entry into the market begins. The manufacturers need a system that can manage these complex, multi-layered processes involved in launching a product. And that system is a pharmaceutical manufacturing software, which supports all the processes such as manufacturing, sales and marketing, production planning and quality management, among others. It ensures they work in full co-hesion with each other ensuring real-time availability of data and approvals, speeding up processes and eliminating costly delays involved in placing your products on the shelves before your competitors.
In sum: If you are into a pharmaceutical manufacturing business, and want to know how a pharma ERP can help you, this blog should be of good help. By understanding the 10 absolutely mind-numbing facts about the pharmaceutical manufacturing software, you now know how important ERP implementation in pharmaceutical companies is.