Quality Control

Shaphaco has an independent quality control department; the principal duties of the quality control unit are listed as follows:

1. It approves:

   • Specifications and testing methods for starting materials, intermediate products, packaging materials and finished products.

   • Sampling procedures.

   • Instructions for sanitation and hygiene.

   • Reprocessing procedures for rejected batches or recovered materials.

   • Other instructions related to the quality of the product.

2. It is responsible of the release or rejection of starting materials, packaging materials, intermediate and finished products.

3. It insures that the stability of the finished products is monitored.

4. It is responsible for the investigation of complaints related to the quality of the finished products.

The quality control laboratories are staffed by qualified persons and are fully equipped for performing all the quality control tests required. The tests are performed in accordance with the written and validated procedures delivered from B.P, USP, European Pharmacopoeias or developed by quality control staff.

Stability Studies:

A written stability-testing program has been established for the finished products and the samples are stored in suitable containers and in simulated market containers at room temperature or at recommended temperature and under stress conditions.

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