Quality Assurance
Quality assurance team ensures that the quality is built into the processes and the systems to ensure that the quality of the products being manufactured is assured. Quality Assurance is the maintenance of a desired level of quality in the product, especially by means of attention to every stage of the process of delivery or production. QA establishes and maintains set requirements for developing or manufacturing reliable products.
A quality assurance system is meant to increase customer confidence and a company's credibility, while also improving work processes and efficiency, and it enables a company to better .compete with others. We believe that "Quality is not an act, it is a habit".We have a well experienced qualified & competent dedicated technical persons in various departments. We have a team of more than 50 persons in Quality Assurance in our plant who take cares of various activities and ensure that all the activities are performed in accordance with the approved procedures and guidelines.
Filter Replacement Policy
Safe Change filter housing is designed to provide operator protector and prevent the dust into the atmosphere when filters are changed. All Ventilation Filters are changed or claimed for maintenance, as soon as the pressure drop across filters deviates from the design range. Such replacement of filter is according to the Standard Operating Procedure AHU List Attached Effluent Treatment Plant We have contract with private company who collect the Waste sludge from our ETP PLANT which is discharge by ETP and dispose it in the authorized municipal corporation place for disposing Sludge.
The Industrial Water Supply is the source of raw water for the plant
Raw water: Raw water of the company is supplied by Industrial Water Supply well which is filtered through sand and activated carbon Purified Water System : The Purified Water System consists of: Raw Water Tank, Sand Filter, Softener, Reverse Osmosis Purifier (RO), Mixed Bed, UV. Purified Water Storage Tank, Loop Distribution System, User Outlets. Raw Water is passes through Activated Carbon Filter, Sand Filter, and RO System. This RO Permeate Water is collected in Storage Tank of 4KL SS Tank (Non-jacketed) Purified Water Generation: 2000 L/Hr. The RO permeate, followed by Mixed Bed filters and finally collected in respective SS 316 Storage Tanks. The Purified Water produced meets the requirements of IP/BP/ USP and In-House specifications. Purified Water Storage Tank: The Purified Water is distributed to Production Department as well as to Multi Column Distillation Plant through Loop System. Purified Water is circulated at a velocity of more thanElectricity Supply:
Maintenance
All the Air Handling Units (AHUs) and Water Treatment Plants are taken in to consideration as per the Standard Operating Procedure of Planned Preventive Maintenance. The Annual Plan for Preventive Maintenance of all AHUs and Water Systems is prepared at the beginning of the Calendar Year. This Annual Plan is prepared with the proposed date of Preventive Maintenance as per defined frequency in Standard Operating Procedure. Preventive Maintenance of all AHUs and Water Treatment Plant is carried out as per the respective Preventive Maintenance Procedures.
Record of the Preventive Maintenance is maintained in the respective checklist prepared as per the corresponding procedures for Preventive Maintenance. Preventive Maintenance of Water Treatment includes sanitization of RO and Mixed bed, and Water Distribution Loops, servicing of Multi Column Distillation Plant, its Distribution Loop. Calibration of Instruments and other Water Treatment Elements is carried out as per schedule carried out as per schedule. The concerned Staff responsible for maintenance are trained about the procedures for maintenance and the relevant formats for recording
Equipment
Major production, Engineering, Warehouse and laboratory equipment: Manufacturing equipment’s are designed, located and maintained to suit their intended purpose. They are designed so that can be easily and thoroughly cleaned. The equipment’s are cleaned according to written procedures and stored only in a clean and dry condition. All the product contact parts are made up of SS316 Stainless Steel. All product contact material is validated during process validation and stability studies on the product.
All equipment’s are designed as per cGMP for ease cleaning and maintenance Initiated following completion of the System / Equipment IQ and may be combined with the IQ in certain circumstances (Plant commissioning). All the measuring devices are calibrated against the calibration protocol and certified. All the parameters are checked against the specification and Protocol & Certified for Performance Qualification.
Performance Qualification
(PQ) Following completion of OQ may be combined with the PQ in certain circumstances. The PQ is the final stage of qualification, which demonstrates how each system will perform when challenged under simulated or actual Production or Operating Conditions.
Prospective Qualification For New Products, Process Validation will be conducted by using the first three production es to demonstrate the process capabilities of the Manufacturing Processes.
Retrospective Validation Retrospective Validation will be conducted based on historical data (trend analysis) etc. This will generally be performed by demonstrating inter batch consistency (minimum of 20 batches) at Commercial Batch Scale Concurrent Validation: Concurrent Validation will be conducted during routine Production of a Products.Revalidation Facilities, Systems, Equipment and Processes, including cleaning, should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review with evidence that facilities, Systems, Equipment and Processes meet the prescribed requirements fulfils the need for revalidation. QA Department releases all validation batches after completion of the validation report, provided that they meet all specifications & have been manufactured in accordance with GMP.
Calibration
A Plan for instrument calibration describes the identified instruments with their technical specifications and frequency for calibration. All the instruments are calibrated as per the respective Standard Operating Procedure. Calibration Status and observations are attached with the individual instruments, showing the date of Calibration and its next due date for Calibration. Calibration Certificates of the instruments and the Certificates of Calibration of the reference standards used during the calibration are preserved for the reference.
If any deviation is found, the Engineering Department informs to concern department and QA yon Intimation Note, and Categories the defect as Critical. Non-Critical, Most Critical Breakdown. The QA Department approves the corrective actions if found appropriate with necessary recommendations
