Short Description of the Quality Management System

Elfin Pvt. Ltd emphasis the importance of supplying their clients with quality pharmaceutical products. All pharmaceutical products are produced under stringent controls which are based on guidelines of Good Manufacturing Practice (GMP) and Good (QC) laboratory practice (GLP).

Quality Policy

Our Mission is to improve live through a culture of continuous innovation by providing 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, environmental control 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 have 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 audits
  • Stability studies
  • Vendor validations
  • Product complaints and recall
  • Validation & Qualification
  • Calibration of Verification

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.
  • Validation analytical method.
  • 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 protocol 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 conduct 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 date for 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 of validations 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

Release procedure (finished products)

Products are analyzed as per laid down specifications. The products that meet the specification are released as APPROVED and may be dispatched. Any product not meeting specifications may be retested as per SOP for OOS and is REJECTED if it does not comply.

Product Recalls

Quality Assurance Dept would make the decision if a recall is necessary and define the class of recall.

Lists of our tests are mentioned below: –

Physiochemical Tests

  • Description
  • Solubility
  • Identification
  • pH
  • Ultraviolet spectroscopy
  • Infrared Spectroscopy
  • Uniformity of Dosages forms
  • Average fill
  • Particulate matterEquipment cleanliness monitoring
  • High performance liquid chromatography
  • Gas chromatography

Microbiological Tests

  • Sterility test
  • Pyrogen test
  • Bioburden
  • Antibiotic susceptibility
  • Water testing
  • Sterile area monitoring
  • Microbiological assay of Drugs
  • Bacterial endotoxins test


  • Testing of containers (Vials/ Ampoules), Rubber plugs & Aluminum seals
  • Testing of Packing material


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