Brazilian Good Practices of Medicament Manufacturing, 4/10

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The Brazilian Good Practices of Medicament Manufacturing was adopted by the Collegiate Directorate of the Brazilian National Health Surveillance Agency (ANVISA) on April 12, 2010.

For specific requirements related to computer systems, see:

• TITLE 1, General ProvisionsDefinition of a Computer System and Computer System Validation
  • Definition of a Computer System and Computer System Validation
• TITLE 2, Quality Management Philosophy and Essential Elements
  • Art. 13: Requires manufacturers to provide adequate computer systems
  • Art. 17-18: Requires qualification and validation to demonstrate that computer systems are designed per GMP requirements and then developed and set up per specifications. Also requires qualification and/or validation of changes that can impact quality
  • Art. 62: Requires self-inspection (audits) of GMP-related computer systems
  • Art. 205: Requires electronic data security and access controls
  • Art. 244: Requires procedures for computer system security, maintenance, deviations, back-ups, and recovery
• TITLE 5, Validation
  • Art. 526: Requires qualification for personnel who enter data into computer systems
• TITLE 7, Computer Information Systems
  • Art. 570 & 576: Provide quality standards for computer systems
  • Art. 571: Requires experience and training for personnel who develop, operated, and validate computer systems
  • Art. 572 & 573: Define the requirement for computer system validation timing (e.g., prospective vs. concurrent) and the system life cycle
  • Art. 574 & 575: Provide technical requirements regarding system location and documentation
  • Art. 577, 578 & 580: Provide data integrity requirements
  • Art. 579 & 584: Provide security requirements
  • Art. 581: Provides audit trail requirements
  • Art. 582: Provides change control requirements
  • Art. 583: Requires the ability to print records for audit purposed
  • Art. 585: Provides system back-up requirements
  • Art. 586 & 587: Requires validation of contingency plans for use during system failures
  • Art. 588: Requires documentation and analysis of system failures
  • Art. 589: Requires formal agreements for out-sourced computer system services
• TITLE 9, Transitional Provisions
  • Allows a maximum of 3 years from the publication date to complete validation of existing computer systems