Overview:

Anvisa has published Resolution RDC Nº 392 2020, that outlines various exception for Pharmaceuticals and drugs during the COVID-19 pandemic including the criteria for the application of exceptions, Good Manufacturing Practices and Import requirements.

Summary of RESOLUTION OF THE BOARD OF DIRECTORS – RDC Nº 392 OF MAY 26, 2020:

  • The criteria and procedures of this Resolution are extraordinary and temporary, in view of the international public health emergency resulting from coronavirus.
  • This Resolution covers companies that manufacture and import drugs and pharmaceutical inputs located in the national territory.
  • Exceptions are understood as the authorization for flexible compliance with technical requirements established by Anvisa through its resolutions.
  • Exceptions provided for in this resolution may only be petitioned in cases where the companies manufacturer of the drug or pharmaceutical ingredient hold a valid Good Practice Certification issued by Anvisa.

GMP Exceptions during COVID-19:

The following technical requirements provided in the Good Practices may be temporarily suspended but only after their notification to Anvisa.  

 I.   On-site audits of suppliers, as long as control actions are taken:

a)    conducting remote audits;

b)   use of audit reports by certifying organizations (service providers);

c)    use of (third party) audit reports carried out by the European Directorate for the Quality of Medicines (EDQM), World Health Organization (WHO) and members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S);

d)   complete analysis on all batches received from inputs according to the monograph approved in the register;

e)    document review for suppliers with prior approval by on-site audit  and good track record of good practice compliance.

II.   Calibration, qualification or preventive maintenance activities, as long as control actions are taken:

 

a)   evaluation of the criticality of the instrument, equipment or system for the intended use;

b)   evaluation of the mean time between failures of the instrument, equipment or system;

c)    performance checks before use;

d)   use of alternative instruments, equipment or systems that conform to calibration, qualification or preventive maintenance, or that can act ensuring greater reliability.

III.  Permission for outsourcing, without inclusion or change of location of quality control, of biological or microbiological quality control tests of drugs and pharmaceutical inputs, performed in the national territory.

IV.   Quality control analyses of imported drugs, performed in the national territory, as long as control actions are taken:

a)   the drugs are imported in their finished form and in their original packaging;

b)   the mode of transport of the imported medicine has a valid operating qualification and the load is monitored during the entire transport; and in cases of cold chain drugs, the temperature must also be monitored.

V.  Sterility test of imported drugs, performed in the national territory, as long as control actions are taken:

a)   the drugs are imported in their finished form and in their original packaging.

VI.  Release of drugs manufactured in national territory with terminal sterilization process, with sterility test in progress, as long as control actions are taken:

a)   the sterilization process is by “overkill” and has been carried out according to its qualification;

b)   market actions are taken immediately at the sign of any failure.

VII.  Transport of finished products from the manufacturing sites to another storage site, without the conclusion of the formal process of release for quality assurance, as long as control actions are taken:

a)   a system is established to ensure that the product is not made available to the market before certification that it conforms to quality requirement.

 

VIII.   Investigation of deviations classified as minor when they do not represent trends;

IX.  Revisions of documents only for the temporal character;

 X.  Face-to-face training intended for periodic updating on Good Practices;

XI.  Internal audits to verify compliance with Good Practices.

Regulatory Corner:

Anvisa has 8 (eight) working days to manifest itself regarding the request. When Anvisa does not manifest itself within the defined period, the implementation of the exception is granted automatically.

This Resolution and the authorized exceptions will automatically cease once  the Ministry of Health  (MOH) recognizes that the Public Health Emergency situation is no longer configured.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations..  To learn more, please contact us at  info@globalregulatorypartners.com

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