Class Controle of Quality of Bioproducts

It intends to provide basic concepts on the implementation of a total quality control system in a biotechnology industry. On lab lessons, students should know how to plan and execute some methodologies applicable to quality control of a company.Laboratory classes aim to apply directly the subjects taught in the lectures. They will be able to make reports and /or analytical reports of the Lab. activities and to consult papers published in international journals.

1. Concepts and definitions of quality and quality control.The implementation of the concept in companies. Quality control systems applied to biotechnology. 2.Application to the pharmaceutical, cosmetic and food industry. Implementation of good manufacturing practices in the company / industry Microbiological, chemical and physical hazards prevention systems.3.Definition of critical points. Metrology. Inspection and test plans. Statistical control of the production process. Principles of control letters. Control charts. Sampling plans. Calculation of sample size.4.Quality audits and quality assurance. Reference to Quality Management: Norms on Management Systems. Quality, field of Application of NP EN ISO 9000, 9001 and 9004, among Others.  5.Practical classes (practical program)Validation of critical points in the system of good manufacturing practices, by studying the shelf life of a pharmaceutical /cosmetic product.Determination of Enterobacteriaceae in food. 

Within the scope of the curricular unit, videos and documents are made available on moodle to support the subject.  These documents and didactic material allow the visualization of programmatic contents and facilitate the learning of the basic concepts necessary to achieve the objectives stipulated for the chair.  Whenever possible, field trips are made to reinforce the syllabus and whenever possible the collection of samples to be used in the practical work of students in the laboratory.

Juran J.M., Gryna F.M. (1991) Controle da qualidade: componentes básicos da função qualidade. Volumes I- IX.McGraw-Hill/Makron, São Paulo.

Federici, M. M. (1994). The quality control of biotechnology products. Biologicals, 22(2), 151-159.