Quality Assurance

Quality Assurance (QA) department is an autonomous department and responsible for assuring of intrinsic quality in the product. This department is manned by highly qualified, dedicated and well experienced professionals.  It performs its role with the support of Quality Compliance department. The main aim of QA department is to build up the overall systematic approach for the production of quality products. This department is dedicated for ensuring strict adherence of the QA systems in accordance with the regulatory guidelines and well written and documented procedures to ensure consistency in finished product to serve safe, affordable, effective, and error free product up to the patient’s level with the motto of quality service in the millions”.

 

The main activities of QA department are listed below:-

  • » Preparation, distribution and control of the documents.
  • » Monitoring of the performance of quality systems and procedures and assesses their effectiveness.
  • » Sets up procedures for the implementation of cGMP norms in manufacturing, packaging, and warehouse and GLP norms in quality control.
  • » Assures regulatory compliance and compliance with organizational standards.
  • » Conduct self audit and provide GMP training.
  • » Evaluates pharmaceutical technical complaints and decides about resulting measures, if applicable in co-ordination with other departments.
  • » Responsible for controlling (release and rejections) of finished products.
  • » Assures validation of manufacturing processes and utilities.
  • » Monitors batch deviations and product review.
  • » Manages change control system and approval of changes in the process.
  • » Approves master processing procedures and master packaging procedures.
  • » Approves or rejects raw materials and packaging materials.
  • » Participates in the establishment of a validation protocol, reviews the protocols and finished report.
  • » Maintains liaison with regulatory agencies with respect to quality of drugs.
  • » In connection with the QA fulfillment in annual product review, reviews production documents, release data, stability, and product complaints, etc to determine trends and issues, and prepare a report.
  • » Oversees the GMP training program which tracks personnel training requirement and record attendance and assure that proper records are kept.
  • » Coordinates hygiene education of personnel of the site with respective departments in consultation with management and monitors its progress (for freshly recruited and senior personnel).
  • » Accompanies government inspectors during inspections for GMP.
  • » Assists in establishing and achieving affirmative action goals.
  • » Maintains effective communication through all departments.

New Product

Career

Know Your Disease

Newsletter

Gallery

Contact Us

Copyright © 2017 npl.com.np All Rights Reserved.

Website Security Test