- Quality Policy & approach:
The Quality system is designed and operated so as to ensure that every unit that is manufactured by us shall adhere to the prescribed standards and requirements for the product.
We shall strive to build customer confidence through value, technology and reliability. Quality objectives shall be set across the whole organization, which shall be pursued, measured and reviewed periodically.
We are working as per all c GMP norms and regulation with highest positive attitude towards quality.
- Master validation Plan:
It Includes description of the validation program including roles and responsibilities
- Identification and location of the facilities, systems, equipment and process/products to be qualified or validated
- References to the procedures and guidelines to be used
- Maintenance and calibration programs
- Training programs
- Change control procedures
- Documentation requirements
- Schedule of activities
Calibration and preventive maintenance:
We believe that Good machine can deliver good quality ,Organization is following the schedules calibration and preventive maintenance schedule for every equipment
Established and maintained documented procedures (including approval, issue and changes of documents and data) to control all necessary documents related to Manufacturing and Quality Assurance.
Self Inspection Program:
All procedures and necessary documents relating to and in connection with the quality system of the location shall be uniquely identified by means of document name, code, amendment number and date (where applicable). In case of controlled procedures, it is responsibility of the departmental heads to implement it effectively and maintained. It is responsibility of QA to ensure that documentation relating to quality system is distributed in accordance with the document control procedures. Customer imposed standards shall also be included under the requirements of controls.
Self Inspection on all systems, procedure and operations shall be conducted regularly in order to monitor compliance with and the effectiveness of cGMP and Quality Assurance principles in the various operations and to allow for improvement and corrective measures here required.
The specification, control and assurance of product quality can be carried out only by competent personnel. Therefore requires documented procedures for identifying training needs and for training all personnel performing activities affecting quality, specifies qualifications, training and motivation as the key factors in achieving quality.
The employees working within Astamed Healthcare (I) Pvt. Ltd are trained as and when necessary to fulfill all activities related to their defined position. The responsibility of such training has been assigned to external experts along with QA department as per SOP.
Training is a continues process and the management and departmental head are, by request or observation identifying and initiating the ongoing training requirements of employees, to maintain and develop the quality and efficiency of operations.
All new employees will provide induction training to emphasis company rules and to initiate familiarization with the company and workplace operations.
Staff/employees appraisal will be conducted annually by their relevant manager to identify and mutually agree the evelopment and training requirements of the employee within the organization.
The in-house training programme consist of :
- Induction programme
- cGMP requirements
- Training on use of equipment (on-the job training)
We are categorizing our complaints as Major ,Minor ,and Critical and investigating in detail. After receiving complaint we are making primary investigation report within 36 hours and giving detailed report after 72 hours.
OOS/Deviation/Incident reporting system/Change control:
Above systems are very effective and closely controlled by General manager QA .Every Deviation ,incident and Change control is investigated with all possibilities and then it is getting approved.
Regarding any query about quality system .We are responding very fastly and having better means of communication. Our first preference will be to Quality communication.