**5. Quality assurance and quality control**

In the pharmaceutical Industry, quality management is defined as the aspect of management function that determines and implements the quality policy.

The major elements of quality management are:


The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are inter-related and have fundamental importance to the production and control of pharmaceutical products.

In fact quality assurance covers quality control in exactly the same manner as it covers other functions such as manufacturing and ware-housing. It approves methods and standards and sees to it that good laboratory practices are operative.

Each manufacturing unit must have a quality control department independent from the production and other departments and under the control of a qualified and experienced personnel and has one or several quality control laboratories at his or her disposal.

Quality control is integral part to all modern industrial processes and the pharmaceutical industry is not an exception. Testing a pharmaceutical product involves physical, chemical and sometimes microbiological analysis. It is a critical function of any business offering a product or service to consumers. In the field of pharmaceutical chemistry, quality control is vital to the successful development, manufacturing, and use of drugs meant to save lives. It determines the quality and stability of drug products via pharmaceutical analysis; it includes areas such as method validation, handling raw materials and finished products, documentations, inspections that impact the development of pharmaceutical products that are governed by specified rules.

Pharmaceutical products are developed and produced according to GMP requirements and other associated codes e.g. good laboratory practices (GLP), and good clinical laboratory practices (GcLP), … etc.

Production and control operations are clearly specified in a written form i.e. standard operating procedures (SOP's) and GMP requirements are adopted.

Control procedures on starting materials, intermediate products and finished products and other in process controls should be carried out according to written and validated procedures.

The finished products should be correctly processed, checked, packed according to defined procedures.

Finished pharmaceutical products should not be sold or supplied unless they are released by an authorized person.
