Our quality is maintained & supported by Total Involvement of all the Staff & Workers along with the executive management. It is achieved by utilising various tools like systematic sampling, testing, validation exercises, periodic auditing of materials / facility / system / procedures.
All systems and procedures are properly documented and Document training is being provided to the staff & workers for their better understanding and implementation. For e.g. SOPs, Product Manuals, Master Validation Plan, Change Control system, etc. have been made and implemented.
Implementation of procedures and systems are monitored by trained QA personnel and by periodic inspections / audits. Periodic reviews of the systems and procedures are done and as per the reports of the audits / inspections conducted, the relevant documents are further revised. |
For effective implementation of this policy, the Management believes in maintaining state-of-the-art factory premises having established systems, procedures & efficient documentation. A team of trained & dedicated skilled personnel implements the quality plan.
The Quality Systems include the control over the Starting materials, In process materials, Packaging materials, Processing and Finished products and monitoring the Quality throughout the shelf life of the product through adequate long term / accelerated stability studies.
These control systems are supported by adequate Documentation System including Master Formulae, Batch Processing Instructions, Raw Materials / In process / Packaging Materials and Finished Product Specifications.
The test results including the raw data are recorded on the analytical worksheets and reviewed before any decision making. The test records also form a part of the Batch Release Documentation and are reviewed for release of Raw Materials, In-process Materials, Packaging Materials and Finished Products. The documents are reviewed for conformance to the laid down process specifications and release specifications.
The supporting systems have been established to ensure that the manufacturing is carried out using suitably qualified processing equipment using a validated process. It is ensured that all the testing is carried out using properly calibrated analytical instruments and a validated analytical method. The microbiological monitoring programs have been developed for ensuring that the manufacturing and testing activities are carried out in a controlled environment.
QA continuously monitors and maintains the data related to testing, analysis, manufacture, in-process controls and any other monitoring of process, process conditions, services including Purified Water system, Environment etc. used in the manufacture of the medicinal products.
To ensure conformance to the Quality Management Systems and Release Specifications throughout the life of the product, adequate systems have been developed for monitoring. These include Self-Inspections, Vendor Development and Audits, Process Validation, In-process testing, Stability studies, Handling of Investigations, Failures and Deviations, Handling of Market complaints and Training. All the monitoring data is collected and reviewed for trend analysis. |
