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One of the imperative and fast-growing sectors in the world is the pharmaceutical. The pharmaceutical industry deals with producing and selling drugs, medicines, and aids that are necessary for treatments and health improvement.

Since the industry is immensely important for maintaining the well-being of people, it is therefore strictly regulated. There are standard practices and certifications that industry players need to follow and adopt to prove that their products are safe and fit the industry and the consumers. There are certain certifications in the pharmaceutical industry, mostly developed by the ISO. Here, in this blog, we are going to discuss some of the prominent certifications within the ISO that you and every company in the pharmaceutical industry should achieve.

Why Certifications are Essential for Pharmaceutical Companies?

Before you know about the key certifications needed by your pharmaceutical company, you must learn why you need them.

Pharmaceutical companies often face many difficulties that make the regulation of quality and safety of their products challenging. Here are the most common challenges.

• Lack of Product Development Efforts: Even though pharmaceutical products are critical for the health and well-being of consumer; these same companies cannot spend enough resources and money on research and innovation to develop new products. New products will no doubt help in the treatment of conditions and medical advancements of other treatments. Many companies are reluctant about spending large amounts of resources or money on R&D because of increased costs of drug development and testing, low success rates, and lower ROI.

• Lack of Confidence in Customers: Still many people are afraid to trust medicines and drugs since it is a matter of their lives. Thus, they seek medical alternative therapies or natural remedies. This creates enormous pressure on pharmaceutical companies to produce and deliver products that consumers can trust.

• Higher Price: Many consumers can afford certain drugs even if they are their price is too high! is mainly because they are produced from rare items and a through complex manufacturing processes. So, it is also the responsibility of businesses to find ways to optimise their costs and provide products at affordable rates.

• Governmental and Industrial Regulations: Government entities as well as regulatory bodies in the pharmaceutical industry provide regulations for ensuring the safety and effectiveness of the drugs and medicines which every company should abide by.

The certifications are not just formal declarations for a pharmaceutical company. They are proof that a company follows the best practices, complies with the applicable regulations, and meets the needs of the customers. The next section explains briefly what certifications your company should obtain.

Key Certifications Needed by Your Pharmaceutical Company

ISO 9001

This is the worldwide accepted standard for quality management and hence, it is the foremost standard for every pharmaceutical company to achieve. This standard underlines a set of principles and best practices that will help you to deliver superior quality drugs or medicines and do so in a manner that satisfies the consumer. This standard can be achieved with other management standards like the ISO 14001 and the ISO 45001 to ensure a safe environment and workplace.

ISO 13485

This is a particular standard for the quality management of medical devices or equipment. Therefore, this standard applies to those manufacturers that also produce medical devices along with drugs. Complying with the standard’s requirements ensures that their devices are safe for use, handling, and meet the needs of the patients. It also helps companies to prevent legal compliance risks that could lead to penalties or litigations.

ISO 27001

This is the international standard for Information Security Management System (ISMS). It is very crucial for companies in the pharmaceutical industry to secure their highly confidential data or information regarding medicines and drugs which include produce formulas, contract details with third parties, and information about suppliers. Complying with the requirements of the standard implies that your business keeps all information regarding products, processes, and stakeholders confidential.

ISO 14001 and ISO 50001

These are the global standards promoting practices for environmental protection and energy efficiency respectively. Compliance to both will help businesses to save the environment, its energy sources, and the future of our planet. Thus, certifying to these very standards will help your pharmaceutical company to demonstrate environmental compliance and improve energy management. This will also enhance the corporate reputation, brand, and create competitive advantage against competitors of your company or within this industry.

Key Takeaway

The importance of these above certifications or simply the quality certification in pharmaceutical industry is undeniable! From ensuring the quality and safety of the medicines/drugs, to ensuring compliance with legal and industry requirements, there are numerous ways these certifications benefit pharmaceutical companies. Also, importantly, the certification(s) will help you to integrate management systems and adopt practices that improve the efficiency of processes and reduce your manufacturing costs. Therefore, you will be able to provide the medicines or drugs at a much more competitive price.

Need help in achieving certifications for your pharmaceutical company? Get in touch with the ISO consultants at Compliancehelp. We have hands-on experience in different certifications and can guide you in getting prepared for required certifications. Talk to our team today!