Quality Control System
Activities Of MHPL Quality Control department
Processes which leads to realization of a product and which always succeeds & delivers its intended outcome in compliance with all the regulatory guidelines & pharmacopeias.
We believe the intent of the Quality Assurance System is to assure that adequate control is maintained throughout the manufacturing process.
For us Quality Assurance is a concept that begins before any product is produced, that is present during all phases of production and is present after production till final testing is complete.
Quality Objectives
The quality objectives are aimed to improve the organization’s operational effectiveness and customer satisfaction.
- Our overall quality goal is to achieve our quality policy, by maintaining the integrity of our QMS
- To seek continual improvement of the QMS in compliance with ISO 13485 Standard 2016 & ISO 9001 Standard 2015.
- Manage and control facilities, processes, quality systems & personnel to cost effectively produce products and furnish delivery services that meet regulatory & customer needs.
- Be committed to continuous process improvement by emphasizing reduction of part-to-part variation and the elimination of all waste.
Quality Management System Planning
“The quality management system planning is carried out to meet the general requirements of the QMS, quality policy and the quality objectives.“
Quality planning in MHPL encompasses the whole facet of operations with focus on the following:
- Identifying of processes needed for the quality management system and their application;
- Determining the sequence and interaction of these processes;
- Determining criteria and methods needed to ensure that the operation and control of these processes are effective;
- Ensuring the availability of resources and information necessary to support the operation;
- Monitoring, measurement and analysis of these processes; and
- Implementing actions necessary to achieve planned results and continual improvement.
Changes that could affect the quality management system are reviewed and quality planning is carried out through management review process and internal audit process.
In MHPL, quality planning includes identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality.