The recognition of the benefits of implementing the regulations on quality led to ISO (International Organization for Standardization) to develop an international standard for quality management systems (ISO 9000) , published in 1987. Meanwhile, the pharmaceutical industry has adopted a system quality assurance that, unlike ISO, were mandatory.
The concept of good laboratory practice (GLP) emerged in the '70s in the U.S. and led to the issuance in 1979 of regulations on good laboratory practice (21 CFR 58), finally adopted in 1997 by the OECD (Organisation for Economic Cooperation and Development ), with the purpose of eliminating barriers to trade in chemicals.
The Good Laboratory Practice is to obtain laboratory data quality, enabling the management of all steps of the study and tracing of data, allowing reconstitution and confirm the results of the study at any time. The key aspects are described below:
The implementation requires a GLP structure with clearly defined responsibilities, organization chart and job description appropriate personnel in adequate numbers and well qualified, requiring constant updating by professionals. The facilities and equipment must be capable of performing the tasks of the laboratory, avoiding contamination, confusion results, among others. It also involves a structure with temperature control, water supply and electricity, cleanability preventing the accumulation of dust and ventilation.
All tests must be conducted according to a predetermined plan, so you can make the reconstitution of the test and can not be changed without the approval of the relevant responsible person.
All operating procedures should be written and available in the workplace and should be regularly reviewed and updated. Obsolete procedures must be filed for the reconstitution of tests based on them.
The priority of the laboratory is the record input samples. The products must be properly identified, indicating conditions of handling, preservation, name or code, lot, date, storage conditions, number and weight of the package.
Registration and documentation are key to implementing an environment of Good Laboratory Practice. The documentation should tell what was done, how it was done when it was done and who did it.
Every study should be followed by a Final Report. The Final Report is the responsibility of the Director of the study and should ensure adequate description of the study and be submitted to the Quality Assurance Unit for review.
Any literature obtained must be stored for long periods, so that they can be redeemed at any time.
The Study Director is the fundamental structure of BPL. It is he who ensures the correct execution of the protocol, as well as its suitability for testing, application procedures, adequate enforcement, registration and interpretation of results.
The quality assurance unit shall ensure GLP compliance in all trials through inspections and audits. This unit can also perform inspections on facilities and outsource suppliers.
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