Accidents can be prevented if a company focuses on the safety issues. To avoid accidents in pharmaceutical facilities, companies needs to consider Quality by Design (QbD) as an important aspect while setting up a pharma unit.
Compliance with safety measures is not only important for the finished goods but also for the raw materials since many hazardous chemicals are used in the pharma manufacturing process and they need to be stored safely. Like any other industry, pharma units are connected with many departments on a regular basis. It is also important to get every department involved while setting up a pharma unit so that they can share inputs without any hassles.
 “Communication becomes even more important as safety initiatives become global in scope due to physical distance, variance in communication technology from country to country, cultural and language differences, and varying regulations.”Alok Ghosh, President – Technical Operations, Lupin |
Alok Ghosh, President, Technical Operations, Lupin highlights the importance of QbD in pharma facilities and says, “QbD is the process to implement the strategies at a planning stage to prevent any quality crises from occurring at a later point. As a concept, it is used across the sectors, in the pharma space. It is especially important as it has the potential to save organisations’ massive damages, both in terms of effort and money.”
He also explains why companies compromise on QbD even when it is extremely important, “Because at a time when manufacturing costs are rapidly growing in this technology intensive industry, it has become imperative for the pharma companies to invest in substantial resources in the planning of a manufacturing unit.”
R&D department
One of the major and crucial departments in the pharma industry is the research and development (R&D), which encompasses chemical research, microbiological research, and pharmacological research. As a result of this diverse nature of pharma R&D, a wide range of chemical and biological laboratory wastes are produced.
Ghosh signifies the importance of the R&D department in the pharma plant, “Today, most of the drugs are produced by chemical synthesis. And numerous types of chemical reactions, recovery processes, and chemicals are employed in order to produce a wide variety of drug products, each conforming to its own rigid product specification,” Ghosh says.
He also informs about the waste streams from chemical synthesis operations that are complex due to the varied operations and reactions employed. The fermentation process generates large volumes of wastes such as the spent aqueous fermentation medium and solid cell debris. Steroids, vitamin B and antibiotics are typically produced using batch fermentation processes. Most processes associated with pharma and research are potentially hazardous for the environment and safeguarding the impact and minimising waste become a critical issue in the industry. The industry itself is trying to overcome such issues.
Safety measures
Pharma formulation plant manufactures is the preparation of dosage forms such as tablets, capsules, liquids, parenterals, creams and ointments. The waste generated during these various formulation processes result from cleaning and sterilising equipment, chemical spills, rejected products and the processes themselves.
 “Pharma companies need to consider all actions in such a way that their activities doesn’t harm environment and make legitimate profit.”Dr R B Smarta Mng. Director, Interlink Marketing Consultancy |
Dr RB Smarta, Managing Director, Interlink Marketing consultancy explains, “Besides manufacturing, manufacturers also should think about waste components which are exposed in the environment. Pharma companies need to consider all actions in such a way that their activities doesn’t harm the environment and make legitimate profit and also develop and create talent pools. Hence, it is very essential to care for the environment.”
Storing
The safety measuresadopted by a a pharma plant is similar to any other facilities. All manufacturing sites need to comply with basic safety measures and equipment at finished products, as well as in raw material sites. Special steps should be taken to ensure that solvent handling and storage is compliant. Adequate alarm and evacuation systems should be put in place.
 “The most important initiative is that of training which needs to be provided periodically to all employees as well as the relevant outside personnel who work on a part-time or contract basis within the manufacturing site.”Debabrata Gupta, Director & COO, USV |
Debabrata Gupta, Director and Chief Operating Officer, USV explains the need for a better storage system in the formulation plant, “The most hazardous chemicals are solvents, which tend to be flammable and also tend to create vapours. These need to be stored and handled carefully. Environmentally safe (eg. flameproof electricals) are a must for handling these solvents. Apart from these, corrosive materials such as acids, alkalis, if not handled carefully, can lead to accidents. Usage of Personal Protective Equipment (PPEs) is a must and should be made mandatory for all operatives dealing with these chemicals.”
 “Companies need to cultivate a culture of safety and make it known that safety is the most important aspect in the company and that short cuts will not be tolerated.”Dr Bhaskar Krishna Arumugam Chief Executive Officer, Granules India |
Dr Bhaskar Krishna Arumugam, Chief Executive Officer,Granules India, speaks on adverse effects of finished products if not stored properly. He says, “There should be no compromise when it comes to properly storing raw materials exercise. Improper storage can be dangerous and have an adverse impact. Cutting corners by improperly handling the material might provide an illusion of saving money, but over time companies with poor safety standards will bear more costs as they stave off lapses. Instead of being reactive, companies should be proactive and implement safety measures and systems, which will ultimately create a better working environment, improve quality and boost productivity.”
He continues, “It is crucial to focus on optimal safety measures while setting up a facility. There might be some additional upfront costs to have strong safety measures in place but the payback period will be short given the benefits a company will bear. Companies need to cultivate a culture of safety and should keep it in mind that safety is the most important aspect in the company and that shortcuts will not be tolerated.”
Ghosh simplifies it and says that companies must develop internal processes to facilitate sharing of information and experience as implementation progresses. Communication becomes even more important as safety initiatives become global in scope due to physical distance, variance in communication technology from country to country, cultural and language differences, and varying regulations.
It is important to have a culture of safety within an organisation. A culture of safety needs to be driven from the leadership team and embraced from top management to floor operators. Safety, plant efficiency and quality are interrelated aspects in operations. Companies functioning within a safe working environment will have less deviations which will lead to higher productivity and will reduce the chances of quality issues. Apart from this, robust safety measures will improve product quality and efficiency, which will ultimately benefit the manufacturers.
According to Gupta, safe and compliant design should form the first step for a new plant. A hazard and operability (HAZOP) studies, which detail out the different possible hazards are recommended. During the commissioning as well as the operational phase, relevant knowledge is very important.
Environment, Health and Safety
The single largest benefit of environment, health and safety (EHS) is that of reducing gas emissions using technological controls. An EHS system also reduces risks, energy consumption, waste, and ensures that the natural resources borrowed from the environment are returned in the similar form and quality.
Ghosh emphasises, “EHS auditing is becoming a global practice around the world and develops superior audit standards. Companies from across diverse sectors like power, manufacturing, construction, telecom, are opting for EHS compliance as one of the key mandates and requirements in order to strike an ecological balance and minimise waste. In an effort to comply with the green policies adopted by the Western countries, Indian companies are being especially forthcoming in their adoption of a proper EHS management system. This is indeed the need of the hour, and critical so as to conserve water, minimise wastage and decelerate global warming as well as depletion of natural resources. More than anything else, EHS is critical to ensure safety and comply with Good Manufacturing Practices (GMP). Along with safer and healthier employees, a strong EHS management system can do wonders in increasing the productivity of an organisation as well.”
Krishna says, “Fostering a mindset that safety is paramount is more important the amount of money spent on SHE. Companies can have state-of-the-art facilities and safety systems but it will not bring any benefit if employees do not believe in safety or are willing to cut corners. Instead of viewing SHE as a cost centre or regulatory obligation, companies should view SHE as an opportunity to distinguish themselves.”
Employee safety
Customers in many markets have moved beyond solely focusing on product pricing. More customers want to make sure that their partners have strong SHE systems in place. Companies with a strong SHE department are likely to be more dependable and less prone to supply disruptions. In addition, robust SHE systems will improve operational efficiency and product quality since it reduces the chance of variation.
Krishna suggests, “All employees should have training with regular updates and they should know that the company takes training seriously. While setting up the facility, there must be regular meetings and forums so that other departments can provide feedback and input. This will eliminate assumptions while setting up the facility and will ensure that unique challenges of every department are addressed. Open communication will result in strong systems and will increase the buy-in from employees, which is critical for a safety system to succeed. Training should not be a one-sided conversation; sessions should be an open forum because it is important for employees to understand why tasks need to be done in a certain way. This will reduce the chance of deviations, which is ultimately the reason for the cause of accidents. “
Gupta avers, “Employees must work in a compliant manner and therefore need to be aware of the circumstances and the environment. Knowledge of materials handled as well as process knowledge is critical for employee safety. Usage of PPEs is essential.” He continues, “Usually any manufacturing site needs to have PPEs in place, a fully equipped healthcare centre and environmental care mechanisms, like a effluent treatment plant which should be functional. The most important initiative is training which will be provided periodically to all employees as well as the relevant outside personnel who work on a part-time or contract basis within the manufacturing site.”
It is imperative that safety measures are at the top of the list of priorities when the facility is being designed. Safety should be viewed as a way for a company to distinguish itself from competitors. According to Ghosh, for an employee, the most important objective is simply to implement the safety measures that are applicable to him/her. Alignment to the goal of ensuring safety, at the plant, will go a long way in ensuring that no mishaps occur. To prevent such situations, employees must be well acquainted with all the relevant safety measures.
In a continuation effort of Lupin, Ghosh reveals, Lupin earns 65 per cent of its revenue from global sales outside India, of which approximately 28 per cent is from the US. Lupin has a capital expenditure of Rs 450 crore which is spent in maintaining and upgrading facilities, thus making sure that environment, health and safety is taken care of.
Ghosh while speaking about his company’s initiatives says, “We at Lupin are committed to adhering to the strictest standards of GMP and GLP. Our manufacturing facilities and plants are all certified by numerous regulatory boards, and we strive to ensure that our processes are EHS compliant. As Indian pharma stands at the cusp of a global transformation, it is becoming increasingly important for us to adopt and sincerely follow higher standards of environmental safety, and return to nature its resources in the same form and quality that we utilise them for industrial processing. This will not only increase our business and competitive advantage by allowing us to attract better global partners, but will also protect and secure our employee safety, as well as environmental sanctity.”
Almost every pharma company complies with environment safety rule to avoid accidents. A well designed plant restricts and active presence of employees help companies to grow without any obstruction. That’s why prevention is always better than restoring process.
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