Importance of GMP Certification from UNICEF for Pharma Companies

Saransh is involved in communicating and implementing strategies internally and externally through decision-making that creates medium- and long-term improvement. He completed education from Oxford University in Drug Development and has achieved success through passion and vision. He engaged in a conversation with the India Pharma Outlook magazine to clear queries on how important UNICEF's GMP certification is for pharmaceutical companies.

How is the UNICEF GMP certification different from other international GMP accreditations?

The UNICEF GMP certification stands out among international accreditations due to its focus on humanitarian aid, emphasizing the quality and safety of pharmaceuticals for children and vulnerable populations. This certification involves a stringent and collaborative audit process that not only assesses facilities but also offers recommendations for enhancements, particularly in quality management systems (QMS), digitalization of processes and sustainability.

Adhering to the EU Annex 1 guidelines, the UNICEF's approach ensures that comprehensive quality and safety processes are maintained throughout the facility. Unlike other accreditations, which may primarily focus on compliance, the UNICEF certification is geared towards building partnerships and fostering continuous improvement, making it a unique and valuable accolade for pharmaceutical companies committed to global health and ethical practices.

What are the factors that enable pharmaceutical companies to win this coveted certification?

Achieving UNICEF GMP certification is a testament to a pharmaceutical company's commitment to global health standards and its ability to meet stringent requirements, driven by excellence. The key factors enabling this achievement include steadfast adherence to continuous GMP compliance and a deep understanding of international regulations. This foundational step ensures that companies not only meet but exceed the expectations set for quality and safety in humanitarian aid.

A company should approach the UNICEF GMP certification process with a learning-driven mindset, emphasising collaboration and openness. This approach underlines the importance of maintaining an open mindset towards audits, fostering an environment where quality and care are paramount. This line of action is crucial for navigating the certification process successfully and ensuring that operations are aligned with UNICEF's goals.

Additionally, UNICEF places significant emphasis on a supplier's capacity to handle bulk and varied orders efficiently. Understanding and quantitatively knowing plant capacities and their constraints are critical in building the confidence of the auditors.

How can the GMP approval from Unicef help pharmaceutical companies in building upon their quality benchmarks?

GMP approval from UNICEF acts as a catalyst for pharmaceutical companies to elevate their quality benchmarks. This collaborative certification process not only validates the existing high standards of quality but also pinpoints areas ripe for enhancement. It serves as a learning platform, pushing companies to adapt and evolve in line with the dynamic compliance landscape of the pharmaceutical industry. Such an audit is not merely an evaluation but a tool for continuous improvement, ensuring that practices are up-to-date and aligned with global needs.

Moreover, UNICEF's initiative of organizing awareness programs for manufacturers and suppliers fosters a deeper understanding of quality benchmarks worldwide. By supplying to diverse regions, companies gain invaluable insights into handling varied quality parameters, including managing temperature fluctuations across different logistics channels. This broad exposure further refines their processes, ensuring that their products meet the stringent standards required in multiple countries and geographies and ultimately enhancing the company's reputation and its commitment to excellence in healthcare.

How can this certification make essential medications more accessible and affordable, especially in low and middle-income countries?

UNICEF's GMP certification facilitates the wider accessibility and affordability of essential medications in low and middle-income countries by enabling pharmaceutical companies like Venus Remedies to leverage economies of scale. The large-scale procurement opportunities presented by UNICEF enable companies to supply high-quality medications at competitive prices, effectively broadening the market while ensuring affordability. Our company’s extensive experience in supplying registered products to over 80 countries worldwide positions it as a key player in UNICEF's mission to make essential medicines available globally.

Moreover, a robust quality assurance process spearheaded by R&D plays a critical role in ensuring the stability and quality of medications across diverse geographic regions. This meticulous validation process guarantees that our products meet stringent quality parameters, supporting UNICEF's efforts in distributing affordable medicines to countries in need. Through such partnerships, pharmaceutical companies contribute significantly to enhancing global health outcomes by making essential medications more accessible and affordable.

Does it have positive implications for companies in the pharmaceutical sector in terms of business, too? Please elaborate.

The UNICEF GMP certification undoubtedly has significant positive business implications for companies in the pharmaceutical sector. First, it provides a tangible boost in business opportunities. For companies like Venus Remedies, the certification is a gateway to new markets, particularly in countries where UNICEF GMP is a recognized criterion for market entry. This recognition not only aids in expanding global reach, but also offers a competitive edge in tender processes, where the certification serves as a badge of excellence and commitment to quality.

Secondly, the certification enhances corporate reputation by associating a company’s brand with UNICEF's values of quality, sustainability and care for the global community. It reflects a balance between maintaining high-quality standards and upholding sustainability, underlining a company's commitment to ethical practices and environmental stewardship. Such recognitions foster trust and open up more partnership opportunities, thus further driving business growth and long-term success in the competitive pharmaceutical landscape.