Quality & Regulatory

Regulatory Services

At Unichrom Laboratories Pvt Ltd, our regulatory services are led by a team of seasoned professionals with extensive expertise in the pharmaceutical industry. This team specializes in managing regulatory submissions, amendments, and communications with global regulatory authorities, including ROW Market. With a proven track record in handling variations, additional data requests, inquiries, on-site pre-approval inspections, and renewal inspections, our team ensures seamless compliance with regulatory requirements.

Quality Assurance

Quality is our core strength. To uphold excellence at every stage, we have established a dedicated in-house Quality Assurance (QA) department. Our QA system is designed and developed to align with all applicable elements of ICH Q7 guidelines. From manufacturer qualification to order execution, we ensure robust procedures and controls are implemented. We have incorporated In-process quality assurance to assure every stage of the manufacturing process. On the clients demand, we may approach State FDA-approved facility for testing.

We use Quality Management System frameworks to guide process efficiency, optimize continuous improvement efforts, and adopt data for evidence-based decision making. We are highly regulated with globally recognized standards to improve quality through transparency, documentation, and systemic approaches to improvement,l Data integrity is maintained throughout the entire manufacturing process, ensuring accuracy and consistency at every stage. We utilize a range of tools for effective quality risk management.

Quality Control

Unichrom Laboratories Pvt Ltd is equipped with advanced, state-of-the-art instruments designed to perform a wide range of analytical processes, including method validation through various sophisticated analytical techniques.

Our team comprises highly qualified and well-trained professionals who ensure thorough inspection and quality checks of materials before shipment. Quality Control is strictly adhered to standards, and specifications to deliver products without defects.

One important aspect of QC is In-Process Quality Control (IPQC), which refers to the continuous monitoring and control of product quality during the manufacturing process itself. IPQC focuses on real-time detection of variations that could lead to defects, ensuring that issues are addressed promptly before they escalate. We follow quality tools like OOS and OOT enable the .swift and efficient, fostering proactive quality management. Its systematic approach enables timely intervention and corrective actions to enhance product quality and regulatory compliance.The APQR data is maintained.

Quality Policy

Quality department of Unichrom Laboratories Pvt. Ltd. is an independent body that functions and reports to Director of the company.

The Quality policy is as follows:

To Manufacture “WORLD CLASS PHARMACEUTICAL PRODUCTS”.
To Satisfy “NEEDS AND EXPECTATIONS OF CUSTOMERS”.
To Ensure “COMPLIANCE OF CURRENT GOOD MANUFACTURING PRACTICES”.
To Built “QUALITY AT EACH AND EVERY LEVEL”.
To Invest in “CONTINOUS DEVELOPMENT AND IMPROVEMENT”.
Assurance to “PRODUCT QUALITY STANDARDS AT AFFORDABLE PRICE”.