Quality Management System

The Incepta Vaccine Limited has established, documented and implemented Quality Management System. The QMS of Incepta Vaccine Limited is established in a frame to describe a Series of activities of the general function of management which determine quality policy, the objectives, responsibilities and implementation of these through measures such as planning, control, assurance and improvement of quality within the framework of the system.

The company maintains and continually improves the effectiveness of the QMS in accordance with the requirements of ISO 9001:2000 and ISO 14001:2004.

Quality Manual, Quality Planning & Quality system procedures are the keys of Incepta Vaccine QMS.

Activities related to Quality are systematically planned, before implementation, thereby reducing the risk and cost of failure and the plans are documented. Each policy, procedure etc. within the QMS is a form of quality plan supporting the achievement of short and long term objectives.

The Quality Manual is the apex document in the Incepta Vaccine QMS documentation Hierarchy, describing the Quality policy, organization chart, responsibility and authority of all the key personnel, the environmental policy and objectives of the organization & indicates how the quality system is managed.

Quality Assurance has the responsibility to ensure the timely implementation and management of the quality system. It ensures that new or revised official requirements or guidelines are reorganized and implemented. Head of Quality Assurance is the official Quality Policy making authority. He issues and manages all quality policies and procedures to guide the organization across all functions and sites to ensure that the requirements of the quality system are effectively implemented and maintained. Results of quality/compliance activities are reported to higher management for review, through periodic review meeting at pre-defined intervals, to assess the effectiveness of the quality system.

The quality unit of Incepta Vaccine comprises of Quality Control (QC) and Quality Assurance (QA). Both QC and QA are independent departments directly reporting to the Plant Head. The principal responsibility of the Q.C. is testing of all materials, which include input materials and output materials. Q.A. is the overall custodian of quality. Q.A. is the decision making body pertaining to all releases and implementation of the designed quality system.

QA is responsible for compliance of IPC, GMP co-ordination and training. Performances of routine GMP checks are done as per need. QA monitors GMP regulation in the manufacturing by instant checks of Batch Record completion, visual checks of cleaning of working place, line clearance, performance checks of balance & other equipment.

QA is responsible for the implementation of the Quality Management System in different areas in collaboration with different departments. Quality Surveillance play active role in conducting external and internal audits with their follow-ups.

Research & Development is responsible for development of new vaccines, new formulations and method development, implementing technology transfer to Production and Quality Control, and also covers process validation, cleaning validation, method validation and follow up stability.

Analytical methods are validated as per ICH guidelines and testing is done on all batches of water, raw materials, in-process samples, finished products and packing material & follow-up stability testings.

The company has established a “documented procedure” to ensure that internal audits are executed as per plan to ensure that the quality management system is effectively implemented and maintained.

Summary results of the reports of Audits are reported for management review. Summary highlights the areas, activities and process where frequent non-conformances are observed and the corrective actions are recommended and taken.

Purchasing - The company has established a documented procedure to ensure that purchased products conform to specified purchase requirements. The company evaluates and selects suppliers based on their ability to supply- Raw material, Packaging materials in accordance with the company’s requirements. Criteria for selection, evaluation and periodical re-evaluation have been established. Records of the results of the evaluation and any necessary actions arising out of the evaluation are maintained.

The company has established a “documented procedure” for preserving the product quality from receipt of materials through internal processing upto the delivery of finished product. These procedures include the product identification, handling, packaging, storage, and protection.

Product Delivery - The cold chain is ensured throughout the delivery processes so that, the product reaches the customer in good quality. This protection is extended to destination wherever contractually agreed.

All air conditioning system servicing production and service area required for room air-conditioning and production processes are designed as per International Standard.

The "Site Validation Master Plan" describes the strategy on qualification and validation covering Equipment Qualification, Process Validation, Cleaning Validation, Method Validation, System Validation, Personnel Validation etc.

“Aseptic filling of finished product” is treated as special process and it is validated. The validation demonstrates the ability of the processes to achieve planned results. The training needs of the personnel are identified & people are trained & evaluated to make them competent for carrying out their activities. Departmental Manager and Supervisors define the training needs.

A medical policy (health) exists for the employees.