On December 30, 2020, Exempt Decree No. 65/2020 was published in the Official Gazette, which updates Technical Standard No. 127 on “Good Manufacturing Practices (GMP) for the Pharmaceutical Products Industry”, adding an Annex No. 6, which provides guidelines aimed at establishing the essential requirements for the manufacture of Radiopharmaceutical Products, thus complementing the standards already established for sterile and non-sterile pharmaceutical products, regulated by the same Standard.
Considering that the manufacture and handling of radiopharmaceuticals are potentially hazardous operations, it is essential that the establishments that manufacture these products comply with Annex No. 6, effectively ensuring the quality of the manufacturing process, taking into account the particular characteristics of this type of products.
To ensure this purpose, Annex N°6 regulates in detail the following issues:
1. Area of application.
2. Personnel of radiopharmaceutical production laboratories.
3. Facilities and conditions to be met by laboratories.
4. Equipment used in the manufacture of radiopharmaceuticals.
5. Radiopharmaceutical production process.
6. Packaging and labeling.
7. Production and distribution records.
8. Quality assurance and control.
The update of Technical Standard N°127 will become effective 6 months after its publication.
Should you require further information on this matter, please contact: Andrea Abascal (firstname.lastname@example.org) and/or Rocío Vergara (email@example.com).