Draft Resolution To Regulate Best Practices In Biological Drug Manufacturing In Colombia
On April 17, 2015, the Ministry of Health and Social Protection published a draft resolution by which the Manual of Good Manufacturing Practices (GMP) for Biological Medicines is issued and the procedure for their verification is set. Below you will find the link to the project.
The main points in the resolution include the following:
– The goal of the GMP manual is to define necessary procedures for the control of biological drugs. Additionally, the manual referred to in this legislative project is intended to complement the guidelines established in the Manual of Good Manufacturing Practices of the World Health Organization; Resolution 3183 of 1995, by which the Report 32 of the World Health Organization (WHO Technical Report Series No. 823) is adopted; and the Inspection Guide for Laboratories or Pharmaceutical Production Facilities (issued by Resolution 1087 of 2001).
– The manual will be mandatory for manufacturers of biological drugs located inside or outside the national territory, for plants that manufacturing active pharmaceutical ingredients or bulk products (if applicable), and for the packers and the finished product itself.
– The procedure to be followed by applicants wishing to obtain the Certificate of Compliance with Good Manufacturing Practices for biological drugs will be governed by Decree 549 of 2001, as amended by Decree 162 of 2004.
– The resolution shall take effect one (1) year after its publication.
The Manual of Good Practices described in the draft resolution defines general guidelines regarding the procedures, responsibilities, facilities, protocols, inputs, production, warranty and quality control associated with the manufacture of biological drugs, without defining detailed rules for specific classes of biological products.
Considering that this draft resolution establishes the requirements to be met by national and international manufacturers of biological drugs, it is necessary to emphasize the aspects of greatest concern and interest for the pharmaceutical industry:
1. The bill in question takes as a reference point Report 32 of the World Health Organization Committee of Experts, which is not the most current version of the technical reports issued by this organization.
2. The reference countries mentioned in Decree 1782 of 2014 on biotech products are not explicitly listed within the procedure for obtaining a Certificate of Compliance with Good Manufacturing Practices.
The Ministry of Health and Social Protection has not established yet the date on which the resolution is planned to be published. However, we consider that during this month the Ministry will make the final decisions and will publish the final version of the resolution.