Quality
Zuventus is leading Pharmaceuticals company committed to maintain high quality standards. At Zuventus, we continuously strive to achieve customer satisfaction by supplying products that meets desired standards of quality.
It is our endeavour to continuously review our all the operations to make them more efficient and relevant with the changing international scenarios.
We ensure to comply with current statutory and regulatory requirements by stringently adhering to Quality Management Systems.
To maintain quality standards at every Plant, we have well defined procedures and system in place in compliance with the current requirements of good manufacturing practices (cGMP), WHO-GMP Guidelines, Good Laboratory Practice (GLP), Good Distribution Practices (GDP) and Good Clinical Practice (GCP). Our objective is to win customer’s confidence through stringent quality control/assurance which has played key role in our rapid success journey.
Our Quality Management System focuses on continual improvement aimed and develop transparency in all areas of operations and build robust quality culture across the organization.
We are committed to deliver high quality products service for customers to increase customer satisfaction.
We are committed to implement a robust quality management system based on our determination to sustain a quality culture at every level.
Our Quality Management System meets and exceeds the expectations of all stakeholders, including patients, customers and regulators. Thus, our passion for quality goes beyond business and statutory requirements and patients is our first motto.
Our Quality Management Team ensures that every Product manufactured and distributed by us complies with the standards of quality, purity, efficacy and safety.
We remain committed to the highest levels of quality and will ensure that all our facilities and Quality Control Laboratories continue to meet the exemplary standards.
Each Manufacturing Plant has well trained personnel for quality department ensuring strict adherence to quality system and procedures.
Zuventus considers all Manufacturers / suppliers of raw materials and packing materials as vendor. Vendor Qualification is a process for evaluation / assessment through Vendor Facility Audit for standards of the vendors as per Zuventus expectation / requirements. All materials required for manufacturing drug product are being procured from approved vendors. A written procedure is in place for qualification of new vendor(manufacturer) / alternate vendor and requalification of existing vendors of all raw materials and primary / secondary packaging materials used for manufacturing of drug product.
Contract Manufacturing Site qualification are done through GMP Audit of the facility to ensure the cGMP Compliance. Quality Assurance checks the Product evaluation/assessment by testing of Product prior to manufacturing. Further Quality Assurance Team monitors the CMO activities at each Site.
We have well-equipped Laboratory for testing of outsourced Products for Chemical / Instrumental / Microbiological / BET sections capable of Analysis of all dosage forms like Tablets/ Capsules / Liquid Orals / Dry Syrup / Injectable / Lyophilized Injectable / Biotech Products / Patches / Powder / External preparations / Ointments / Food Products / Ayurvedic Products etc.
Product/ batch testing and Stability Testing done at this Lab to ensure the Product is of quality standard.
Our Quality Assurance checks the Physical Verification of each batch of Product with defined criteria and review of batch COA received from Contract Manufacturing Plants after receipt of Product at Central Warehouse. Our Quality Assurance checks the correctness of overprinting details, Pharmacopeia status, Labelling requirements as per D&C Act. Cold chain / Cool chain Products verification for desired temperature at the time of receipt.
We ensure the timely delivery to Production of right quality and quantity of materials for manufacturing / packing of Products. Manage the physical flow of materials and products while maintaining the quality, security and traceability. Ensure that Zuventus customer receive the quality product, at the right time.
Cold Chain Facility:
Zuventus has well equipped facility of cold chain Products for storage, transportation till the pharmacy.
- Online Temperature monitoring system (TMS) at different Warehouses
- Development of cold chain coolant box as per requirement with Validations for transportation
- Handling of temperature excursion incidences / investigations and CAPA by performing different thermal cyclic studies
- Control on packaging components e.g. thermocol box / corrugated boxes / coolants with respective specifications
Resources and Infrastructure:
- State-of-the-art manufacturing facilities and quality control laboratories
- Competent corporate quality team (CQA) to support and focus on key functions, comprehensive quality policies and procedures
- Corporate Quality department ensures that the latest updates in GMP are being translated into guidelines, standard operating procedures (SOPs) and protocols at our Sites
- Competent, enthusiastic and dedicated staff
- Zuventus organizes training to build professional capabilities and enhance employees technical and behavioral skills
- Each site has well trained personnel for quality control along with a Quality Assurance department ensuring strict adherence to quality systems, procedures (SOPs) and documentation.
- Quality Control Laboratories are well equipped with sophisticated instruments like HPLC, GC, UV Spectrophotometer, FTIR, Particle counter etc.
- Integrated and latest software like SAP (S4 HANA), TrackWise, DMS, Training Software being used across the Organization.