Facilities

Pharmaceuticals Product Development is challenging venture for local & global market and development of novel drug including biotechnological products. Constantly pumping of new products in market helps the company to survive and build up its image. Personnel of Product Development department always try to provide an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process. It is important to recognize that quality cannot be tested into products, but should be built in the product by design. We introduce innovative high quality (efficacy & safe) new product considering cost effective. Our Product Development team emphasize on successful in developing & introducing quality products according to ICH guidelines and continuous improvement of new and existing product for customer satisfaction, environmental change,  technology change and other competitors.

For that, we have dedicated and trained R&D personnel along with well-equipped separate Analytical laboratory with all necessary machineries and equipment of GMP standard in pilot scale.

Quality is the mainstay of our competitiveness. Our objective is to constantly achieve quality excellence. To achieve this, we take considerable focus in adherence to the QA policies. Quality Assurance, though an independent function, works as an interface between R&D and manufacturing strictly abiding with the standardized quality system, providing consistency, effectiveness and efficiency for all manufacturing activities across all our manufacturing locations. An excellent team of professionals having good understanding of concepts of quality systems and cGMP is working to ensure Quality Assurance at each stage right from receiving of starting materials to finished products to assure the highest international standards.

The major functions covered under the supervision of Quality Assurance:

• All validation activities including System validation such as Water system & HVAC system, Facilities validation such as Room qualification(RQ), Machine/Equipment validation (IQ, OQ, PQ), Process validation, Analytical method validation
• Approval of raw & packaging materials and finished products & batch release
• Monitoring of manufacturing processes through in-process control
• Implementation of cGMP
• Medicinal products are not sold or supplied before a qualified person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorization and any other regulations relevant to the production, control and release of medicinal products;
• There is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system.
• Quality Compliance is responsible for change control management, deviation control, handling of product complaint, product recall handling, Product quality review, documentation management.
• Quality assurance is responsible for self-Inspection, policy preparation, gap analysis, validation, personnel training, and qualification, ensure data integrity onsite and also confirms quality system as per regulatory requirement.
• Quality Assurance is responsible for review and evaluation of quality performance indicator, progress review and self-monitoring of Quality CAPAs, quality projects.
• Quality Assurance is responsible for management of retention sample and APQR of finished products.