Page 11 - PR 2014 2016 06 Radiopharmacy

Radiopharmacy | Progress Report 133

resulting in at least 3 finalized doctorates regulations for GMP and marketing authoriza-
and other still in progress. tion of radiopharmaceuticals were published
by ANVISA (Resolution RDC 63 and 70). The
Quality Assurance in “Technical Committee of Radiopharmaceuticals”

Radiopharmaceutical from the Brazilian Pharmacopoeia is elaborat-

production ing the monographies of radiopharmaceuticals
produced in Brazil. IPEN participates in this
work group which reflects the importance of
Preparation of radiopharmaceuticals for in- the radiopharmaceuticals in the context of
jection involves adherence to regulations in pharmaceutical production in Brazil. In the
radiation protection as well as to appropriate Radiopharmacy, the Quality Assurance Man-
rules of working under aseptic conditions that agement is responsible for maintenance and
should follow the regulations on current Good improvement of the Quality Management
Manufacturing Practices (cGMP). Good Manu- System (according to ISO-9001-2008) and the
facturing Practices (GMP) is a system designed implementation of all the aspects related to
to ensure that pharmaceuticals are consistent- GMP in production and quality control of radio-
ly produced and controlled according to quality pharmaceuticals. There is a group responsible
standards, with a view to eliminating the risks for control, maintenance and improvement of
involved in drug production. The compliance data generated in the production and quality
of GMP is directed to minimize the risks pre- control process and all documents of the Qual-
sented in the pharmaceutical production that ity Management System. The accompaniment
cannot be detected in the analysis of the final of non-conformities generated in the System
product: cross-contamination, contamination and the attention to the fulfillment of ISO 9001
with particulate material and change or mix- are also attributions of this group. The Quality
ture of products. Quality Assurance is a wide Assurance Management coordinates the In-
ranging concept which covers all matters that strument Calibration, Equipment Qualification,
individually or collectively influence the qual- Process Validation and also the implementa-
ity of a product. It is the total arrangements tion of other GMP requirements. The Quali-
to ensure that medicinal products have the ty Assurance Management can oversee the
required quality for their intended use. Quality production and quality control operations to
assurance therefore incorporates GMP and ensure that a radiopharmaceutical is produced
thus Quality Control. Because of their short according the specifications. It is the respon-
half-lives, many radiopharmaceuticals are sible for approving or rejecting components,
released and administered to patients shortly in-process materials and finished product to
after their production, so that quality control ensure compliance with procedures and spec-
(e.g. tests for sterility and radionuclidic purity) ifications affecting the identity, concentration,
may sometimes be retrospective. The imple- quality and purity of the radiopharmaceutical.
mentation and compliance with the quality In the last years, the maintenance of the ISO
assurance program are therefore essential. 9001 Quality Management System Certifica-
Manufacturing practices are the methods, fa- tion was very important and contributed to
cilities, and controls used in the preparation, the introduction of the GMP concepts.
processing, packaging, or holding of a drug. The
GMP in Brazil is published in the Resolution Some aspects of the GMP applied to the Quality
RDC 17 of 16 April, 2010 of ANVISA. Specific Assurance Program are of special interest and