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Home > About us > Company Profile > Quality Control

Quality Control

Julphar is committed to providing the best quality of medicines to its customers. Quality control fully supports a formal and continuing program of preview, evaluation and modification at all levels with a view to providing products of the highest quality.

Julphar strives to take all necessary steps to ensure the quality and potency of each product which it manufactures as per international standards. This ensures their demand in the competitive international markets. Observing the highest quality control standards, therefore, is serious business at Julphar. The Quality Control department at Julphar continuously strives to see that every product, packaging, and unit of medicine produced at Julphar is of the highest standard.

The Quality Control department plays a vital role in every stage of production – from raw materials analysis, and bulk finished product analysis to microbiological/biochemical analysis for all pharmaceutical products produced by Julphar. The Quality Control department prepares statistical sampling plan for vendor approval and participates in process validation, product specification and cleaning validation of all products, including injectables. Dosage form testing is done in respect of biochemical analysis of human insulin crystals and erythropoietin.

Salient role:

> In-process quality checks during manufacturing.

> Assessment and evaluation for approval of API manufacturers.

> Validation/calibration of analytical instruments as per plan.

> Record verification.

> Release of batch for marketing.

> SOP compliance, storage of quality records and control samples.

> Stability studies for biotechnological products.

> Root cause determination for customer complaints and corrective actions.

> Fully adhere with GLP practices and meet the most stringent

regulatory requirements set by US FDA, WHO, ISO and EMEA.

> Successful training to develop professionally and highly skilled analysts.

Quality Control department is equipped with highly sophisticated analytical instruments for quantitative analysis of raw materials and finished pharmaceutical products, besides conventional methods for characterization of raw material, bulk and finished products; and insulin and Epotin analysis.

The Quality Control team is highly qualified and experienced. With the help of continuous on-the-job training to the staff, Significant milestones have been achieved by the department which includes reduction of lead time analysis, with highly accurate results.