Pharmaceutical company SANTO has successfully earned Good Manufacturing Practice (GMP) certification, enabling expansion into fresh market territories.
Rewritten Article
Taking a leap forward, the pharmaceutical powerhouse, SANTO, eyes global expansion with a cocktail of antidiabetic drugs - sitagliptin and dapagliflozin. Yet, factory director Rustam Baigarin emphasizes that this is merely the appetizer.
Bagging the coveted certificate marks the culmination of a radical overhaul in SANTO's production processes. The GMP standard, an international benchmark for quality-sensitive goods such as medicinal products and food, sets the stage for this transformation.
The production workshop for solid dosage forms served as the testing ground. In this battlefield, two new working stations saw the light, one dedicated to dry granulation of tablet mass, uncharted territory for SANTO, equipped with German machinery. Notably, a serialization system was installed, a fairly fledgling practice in Kazakhstan but a staple in European pharmacies. Moreover, the automation of secondary packaging processes received a green light. Now, SANTO's procedures mirror those of the titans of the European pharmaceutical industry.
One cannot dismiss the importance of cultivating a quality-centric work culture. As Baigarin puts it, "each employee should perform their duties as if an inspector is watching over them, scrutinizing every move."
The Quality Mindset, as dubbed by SANTO, aspires to ingrain a high standard of quality in every aspect of the production process.
Vojtech Zbanyshek, SANTO's quality director, chimes in, "The SANTO Innovation and Quality Center, built in preparation for the European GMP certification, is a testament to our commitment to quality. Obtaining the GMP certificate underscores that our medicinal products meet global quality standards."
With an inventory exceeding 280 unique medicinal product names catering to twelve diverse pharmaceutical groups, SANTO confidently struts its stuff as an international powerhouse, GMP-certified and ready for the global stage.
Gaining the European GMP Certification: A Closer Look
Securing the European Good Manufacturing Practice (GMP) certification is a defining moment for any pharmaceutical company. It demonstrates a commitment to producing high-quality, safe, and effective medicinal products that meet stringent European Union (EU) standards.
- Quality Assurance: GMP compliance demands a focus on quality assurance in every stage of production, from sourcing raw materials to quality control checks at the final product.
- Regulatory Adherence: Companies must adhere to detailed guidelines and regulations, such as those outlined in the EU GMP Volume 4, to ensure compliance. This includes maintaining thorough records, training personnel, and maintaining facilities cleanliness and control.
- Market Access: GMP certification is often a prerequisite for selling pharmaceuticals in the European market, guaranteeing that products meet EU standards.
The Impact of European GMP Certification on Antidiabetic Drug Production
For a company like SANTO, GMP certification brings several advantages when it comes to antidiabetic drug production:
- Enhanced Productivity: GMP compliance ensures that antidiabetic drugs are produced under stringent quality control measures, reducing the risk of errors and ensuring the safety and efficacy of the products.
- Market Expansion: With GMP certification, SANTO can explore new markets, as they can now legally export their products to Europe and other regions requiring similar standards.
- Regulatory Compliance: The certification helps SANTO adhere to regulatory requirements, minimizing the risk of non-compliance issues and potential penalties.
- Increased Trust: GMP certification instills faith in consumers and healthcare providers alike, as it's a globally recognized symbol of quality pharmaceuticals.
I, as a quality-focused employee at SANTO, strive to maintain the high standard of quality in our production process through the Quality Mindset, which aligns our practices with European GMP standards. This certification ensures that our health-and-wellness products, such as our antidiabetic drugs like sitagliptin and dapagliflozin, meet international health and safety regulations.
With the European GMP certification, SANTO's antidiabetic drug production benefits from enhanced productivity, market expansion, regulatory compliance, and increased trust from consumers and healthcare providers worldwide.
