Welora Lifesciences Pvt. Ltd. emphasis the importance of supplying their clients with quality pharmaceutical products. All pharmaceutical products are produced under stringent controls and under certifications of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and ISO 9001-2008.
Quality Policy
To improve the lives through a culture of continuous innovation byproviding high quality pharmaceutical and healthcare products and services while achieving customer satisfaction, enhancing employee development and stake holder’s returns.
Quality Control
Sampling and analysis of raw materials, packing materials, intermediates & finished products.
- Release of raw material packing material for processing and packaging.
- In process quality checks.
- Microbiological testing of raw materials, finished products and water, environmentalcontrol test.
Quality Assurance
Being a quality-focused company, we have achieved a remarkable position in the industry by offering a range of topnotch quality pharmaceutical products that are non reactive, anti-inflammatory, effective, standard in composition and having a long shelf life. We are highly admired and demanded amongst the customers for our quality driven approach setting us apart from our competitors.
Q.A. is responsible for:
- Maintaining GMP at all stages of production and control.
- Review of production records.
- Review of product specifications and test procedures.
- Release of Finished Goods.
- Quality standards and its audits as per GLP compliances.
- Stability studies.
- Vendor validations.
- Product complaints and recall.
- Validation & Qualification.
- Verification of Calibration.
Elements of Q.A. System
- Specification and clearly written job responsibility for each and every employee.
- Specify and clearly written standard operating procedure and work instructions.
- Validated processing procedure.
- Specification of Raw Material, Packing material, Work in progress and finished goods.
- Validatedanalytical methods.
- Data collection and Statistical evaluation of quality.
- Vendor Audits.
- A complete validation Master plan.
- A well-designed complaint handling and product recall system.
- Develop/Issue/ preview of all protocols jointly with user department.
- Review of all material documents / SOP’s.
Quality Audits
- Stability studies.
- Vendor validations.
- Product complaints and recall.
- Self inspection.
Self Inspection
- A Self-Inspection team comprising the Production Manager, Quality Assurance Manager, Quality Control Manager and Maintenance Manager conducts Integral Audits periodically as per an established plan.
- An inspection report is prepared after the inspection of facilities and systems. The report is circulated to the people concerned with an action plan and target datefor its completion. External audits are also carried out by various agencies from time to time and the compliance with any points raised is documented.
Review of Results
The efficacy, safety and quality of the product are ensured through a series ofvalidations carried out upon manufacture and analysis. Each production batch is reviewed by QA for completeness of manufacturing, analysis, Packing, IPQC, Yields deviations etc. prior to the release of the batch.
Assessment of suppliers
The company maintains its own vendor audit and appraisal system to evaluate suppliers.
Vendor Approval
- A complete vendor validation plan takes care of Suppliers of critical starting material and packing materials which are assessed by routine audits/ by questionnaires.
- Approval/authorization, distribution, control, Review, storage and destruction of production records.
- Review of product specifications and test procedures.
