Quality Assurance

Quality Assurance : exists to serve a number of objectives that include the following:

To offer a guarantee that the person who is administering medicine is confident that every unit will achieve the desired effect.

To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.

To ensure the law is complied with to the latter.

To offer protection of the manufacturing organization.

Calibration services are a vital component of quality assurance. RS calibration plays an important role in various aspects of quality assurance in pharmaceutical industry, such as good manufacturing practice, product releases as well as commercial implications. They play the role of a sentinel, ensuring adherence to regulations as well as identifying possible shortfalls and making recommendations for improvements that may be made over time.

Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP);all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out. Regular evaluations of the quality of pharmaceutical products are conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.

Standard operating procedures and associated records of actions taken or, where appropriate, conclusions reached are available for: (a) equipment assembly and validation; (b) analytical apparatus and calibration; (c) maintenance, cleaning and sanitization; (d) personnel matters including qualification, training, clothing and hygiene; (e) environmental monitoring; (f) pest control; (g) complaints; (h) recalls; (i) returns.

The independence of quality control from production is considered fundamental. Quality control as a whole will also have duties, such as to establish, validate and implement all quality control procedures, to evaluate, maintain, and store the reference standards for substances, to ensure the correct labeling of containers of materials and products, to ensure that the stability of the active pharmaceutical ingredients and products is monitored, to participate in the investigation of complaints related to the quality of the product.

Al Rai is completely equipped with High performance liquid chromatograph, Gas chromatograph, Atomic absorption spectrophotometer, Fourier transform Infrared spectrophotometer, UV-Visible spectrophotometer, Dissolution test apparatus, Disintegration tester, Total Organic carbon analyzer, Osmometer, Densitometer, etc.