The QMS of Incepta Pharmaceuticals Limited is established in a frame to describe its operations in different documents and practices which is based on the principles of PICS and WHO guidelines. The Quality Manual describes the Quality Policy of Incepta Pharmaceuticals Limited.
The responsibilities for the technical aspects of Quality Assurance are defined in the Quality Manual. It encompasses all activities necessary to generate, maintain and verify the quality of drugs.
The Quality Assurance of Zirabo Plant consists of Quality Control, Quality Compliance and Quality Surveillance. The main tasks and duties of Quality Control have been described in the Quality Manual and relevant SOPs. The Head of Quality Assurance or his delegates are responsible for releasing drug substances, excipients, dosage forms and packaging materials.
Quality Compliance is responsible for IPC, GMP co-ordination and training. Performances of routine GMP checks are done as per need. Monitors to respect 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.
Quality Surveillance 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 formulation development and method development, implementing technical transfer to Production and Quality Control, and also covers process validation, cleaning validation, method validation and follow up stability.
The Quality Manual describes how testing instructions are established and used. The testing instructions include the specifications and testing methods. The testing instructions are binding for release testing and for follow-up stability testing.
A routine inspection is being done in the name of "Self Inspection" mainly concerned with safety, sanitation and infra-structural facilities leading to GMP including documentation.
Supply of raw materials are mainly obtained from approved suppliers. We select and evaluate the supplier as per procedures. This procedure is also applicable in case of supply of Primary and Secondary Packaging Materials.
Change Control Procedure
The Quality Unit along with other appropriate functions are responsible for coordinating activity in their respective areas to ensure that there is an assessment of all proposed changes and that approved changes are communicated to all affected parties. They are also responsible for Change Control Procedures, documentation, evidence and continuous support and maintenance for implemented changes.
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
Training is a routine function. The training needs depend on the function of the employee. Departmental Manager and Supervisors define the training needs.
A medical policy (health) exists for the employees.