Quality Assurance

At Sharing Formulations Pvt Ltd, we are dedicated to ensuring the highest levels of quality in all aspects of our pharmaceutical operations. Our Quality Assurance Policy reflects our commitment to maintaining consistent quality throughout our processes, from research and development to manufacturing, distribution, and customer support.

• Compliance with Regulatory Standards: We strictly adhere to all applicable local and international regulations and guidelines, including those set by regulatory authorities such as the Food and Drug Administration (FDA). Our quality assurance practices are designed to meet and exceed these standards to ensure the safety, efficacy, and reliability of our products.
• Robust Quality Management System: We have implemented a comprehensive Quality Management System (QMS) that encompasses all aspects of our operations. Our QMS is designed to provide a framework for quality assurance, encompassing processes, procedures, and documentation requirements. It is regularly reviewed and updated to reflect changes in regulations and industry best practices.
• Risk-based Approach: We adopt a risk-based approach to identify and manage potential risks to product quality. Through risk assessments, we identify critical control points in our processes and implement appropriate measures to mitigate risks. This allows us to allocate resources effectively and prioritize areas that have the most significant impact on product quality.
• Standard Operating Procedures (SOPs): We develop and maintain robust Standard Operating Procedures for all critical processes. These SOPs outline detailed instructions and guidelines to ensure consistency, accuracy, and reliability in our operations. Our employees are trained to follow these SOPs and are regularly audited to ensure compliance.
• Training and Competence: We invest in the training and development of our employees to ensure they possess the necessary knowledge and skills to perform their roles effectively. Training programs cover areas such as Good Manufacturing Practices (GMP), quality control techniques, regulatory compliance, and product-specific requirements. This continuous development enhances employee competence and contributes to maintaining quality standards.
• Validation and Qualification: We conduct thorough validation and qualification activities for equipment, processes, and analytical methods to ensure their suitability for their intended purposes. This includes qualification of manufacturing equipment, validation of critical processes, and verification of analytical methods. These activities are performed according to industry guidelines and documented appropriately.
• Continuous Monitoring and Improvement: We maintain a system of ongoing monitoring and evaluation to ensure that quality standards are consistently met. This includes regular audits, inspections, and self-assessments to identify areas for improvement. We utilize feedback from employees, customers, and stakeholders to drive continuous improvement initiatives and optimize our quality assurance practices.
• Documentation and Record Keeping: We maintain comprehensive documentation and record-keeping practices to capture all quality-related activities and ensure traceability. This includes documentation of processes, procedures, batch records, testing results, and product release records. These records are securely stored and easily accessible for review and audit purposes.
• Supplier and Vendor Management: We establish strong relationships with our suppliers and vendors based on mutual trust and collaboration. We conduct supplier evaluations and audits to ensure their ability to meet our quality requirements. We also maintain clear quality agreements with suppliers and vendors, outlining the responsibilities and expectations regarding quality assurance.
• Continuous Customer Feedback and Satisfaction: We actively seek customer feedback and monitor customer satisfaction to identify areas for improvement. Customer complaints and inquiries are recorded, investigated, and addressed promptly, ensuring timely resolution and customer satisfaction. We use this feedback to drive corrective actions and enhance our products and services.

This Quality Assurance Policy is communicated throughout the organization to ensure that all employees understand their roles and responsibilities in upholding our quality standards. We are committed to a culture of continuous improvement, where quality is embedded in every aspect of our operations. By adhering to this policy, we aim to exceed customer expectations, comply with regulatory requirements, and maintain our reputation as a trusted provider of high-quality pharmaceutical products.