SOPs for Pharmaceutical Industry
The criticality of the pharmaceutical industry has been reiterated once again in the recent surge of global demand for vaccines to fight a pandemic that has brought the world on its back foot. From life-saving medicines to cure for the common cold, the human race is heavily dependent on the pharma industry for its health and healthcare requirements. It also fulfils our need for medical instruments, devices, surgical utilities, etc. In many countries, Ayurveda and homoeopathy also form parts of the pharmaceutical industry.
Both public and private sector enterprises in the pharma industry have a tremendous responsibility on their shoulders in ensuring that they are able to address, forecast and meet the global standards and requirements of securing public health in good condition. This responsibility goes beyond business despite the fact that the commercial aspects also cannot be ignored especially in the private sector.
The pharma industry comprises suppliers, manufacturers, distributors, retailers, import-export traders, etc. of raw materials, medicines/consumables and medical/healthcare devices/instruments. Having sound processes and operations help these businesses ensure that their products and services deliver the intended value to the end-users. And the key to it is better business process management (BPM) through SOPs (Standard Operating Procedures).
Challenges Faced Due to Poor Processes & Management Systems
Lack of Automation. Automation speeds up businesses processes and operations. But to automate a business activity, it must be given a definition in terms of operational standards and procedures. This will help in identifying the automation requirements. Businesses that are not process-oriented find it difficult to map their automation needs. For example, bar code scanning at the time of billing significantly reduces the waiting time for customers in pharmacies. But if a medical store is not serious about becoming process-oriented and improving its operational efficiencies and customer experience, the need for process automation is unlikely to be recognized.
Meeting Market Demand. To successfully meet the market demand, businesses have to ensure the availability of stock as per demand forecasts or orders. A manufacturer has to set and meet its production targets. A retailer has to place orders to distributors. An export trader has to procure its inventory from suppliers. In essence, to meet the market demand, the corresponding volume of supply has to be ensured. Therefore, the production, supply chain, and/or distribution activities of businesses must run very efficiently and effectively. However, if these activities are not designed to run as strong processes and systems, there would be gaps between the demand requirements of the market and the value/supply chain activities of businesses.
Handling Inventory. Inventory management has two important operational aspects – paperwork and physical. The paperwork (which is also done digitally) deals with initiating purchase indents, communication between departments and with suppliers/distributors, bookkeeping of incoming and outgoing inventory, quality control reporting, etc. The physical aspect is related to activities that involve tangible interaction with inventory like counting, measuring, quality checks, lifting, loading, dispatching, etc. Both the paperwork and physical aspects must go hand-in-hand following the right sequence. This calls for a process-oriented approach for planning and executing inventory management activities. These two aspects will not work in tandem if inventory management processes and operations are not planned and mapped to achieve the objectives of the inventory function.
Training Needs. Training needs and specifications cannot be identified where the work procedures are not defined. With procedures in place, it becomes feasible to follow and keep track of the strengths and weaknesses in performances. The struggling areas in performance could be identified when the actual work and results deviate from the standards set. For example, if the delivery timelines are consistently missed by a few members of the delivery team, the problem deserves further analysis. It might be possible that these employees are new to the location assigned to them or they are not very convergent in using the GPS feature.
Lack of Customer-centric Approach. Especially in pharma retail, being focused on customer needs and experiences is critical to compete effectively against both online and offline stores. A strong CRM helps to better understand consumer behaviour, improve customer experience, come up with better product ideas, attract new customers, build more web traffic and user engagement, achieve higher conversion rates, etc. Not having strong CRM processes and systems aided by automation and analytics to achieve insights required to bring these results and improvements would stymie marketing success.
Inadequate Quality Control Measures. Amidst the pandemic of 2020, the global demand for hand sanitizers and face masks surged unprecedentedly. The pharma industry was not ready to handle such levels of demand. But months later the supply in the market was boosted with inferior quality products priced exorbitantly. The problem was the entry of a large number of small, ad-hoc and new players in the market with poor concerns for product quality. This happens and will happen every time processes and QC measures are sent for a toss.
Poor Organizational Functioning. Every business needs a strong organization structure to function as one unit. There could be multiple departments, projects, processes, and operations, all going on at the same time. There are interdependencies involved and a need for synchronized functioning. Where the processes and systems are poorly designed and mapped, these interdependencies cannot actualize that will eventually lead to disruptions in the flow of communication and work across the organization. The core and support functions are critical for any business including ones in the pharmaceutical industry.
Benefits of SOPs to Pharmaceutical Industry
Standardization. When there is consistency in how a business process is being carried out, it leads to scope for improvement. This improvement shows up in resource utilization, quality of output, lesser operational errors, etc. It calls for establishing the roadmap for carrying out a business process otherwise compliance to it cannot be achieved. This technique of establishing the standards of how a process must be carried out is what we know as standardization. No matter in which country or regional branch of a business enterprise the process is being executed, the same set of standards is followed (except minor customizations suit local conditions). SOPs are the means through which organizations incorporate the required operational standards in the execution of their business processes.
Quality Control. Quality is a critical consideration for businesses in the pharma industry, especially for the manufacturers and suppliers because the burden of ensuring quality originates from the source of raw materials. With SOPs for quality control or QMS (Quality Management System), businesses can place the filters through which only the materials/semi-finished products/final products could move down the value chain or for marketing and distribution. The absence of or having poor quality filters means that once a defective material enters the system it might spiral down to the end-users. This is something businesses must avoid especially when it comes to critical healthcare solutions with the aid of quality assurance standard operating procedures.
Robust Supply Chain Management. To be able to meet the market demand consistently and efficiently, the supply chain must be working without glitches. This cannot happen by itself. Supply chain is a massive function comprising inventory management, production, logistics, warehousing, distribution and delivery and returns management. All these functions and processes must work perfectly not only as individual departments but also in cohesion with one another. SOPs can define the operational framework of every process in every department/function and is also the operational language that can define the network of interdepartmental functioning. For example, when a purchase order is finalized, the logistics function must also be informed. And when the logistics team gets the information, it triggers their SOPs to coordinate the transportation required to fulfil the purchase order.
Strong Organization and Principled Management. Every business enterprise needs a strong organization governed by principles of management to sustain the business enterprise. A strong organization provides for division of work, discipline, clear-cut authority-responsibility relationships, formal flow of communication, unity of command, direction to flow of work, scalar functioning, etc. The nature of SOPs is such that these considerations cannot be ignored. While developing SOPs, one must define the scope of duty, reporting and supervision, sequence of activities, expected standards of performance and results, etc. Designing and implementing a strong pharma SOP framework can also help businesses in this sector in organizational change management through change control SOP in pharma. SOP in pharmaceutical industry plays a big role in helping businesses build stronger organizations and become process-oriented enterprises.