SQA Regulatory Surveillance Summary for May and June 2024
SQA Regulatory Surveillance Summary for May and June 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA will use Analysis of Equivalent Foreign Authorities for Inspection and GMP Certification Process, 03 May 2024 In the Official Gazette of the Union, ANVISA has published the Normative Instruction (IN) 292/2024, which […]
SQA Regulatory Surveillance Summary for March and April 2024
SQA Regulatory Surveillance Summary for March and April 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) Anvisa Extends the Validity Period of the Certificate of Good Manufacturing Practices to Four Years, 22 March 2024 The validity of the Certificate of Good Manufacturing Practices (CBPF or cGMP) of […]
SQA Regulatory Surveillance Summary for January and February 2024
SQA Regulatory Surveillance Summary for January and February 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Publishes New Edition of the Biovigilance Manual, 17 January 2024 In Brazil, biovigilance covers a set of monitoring and control actions, ranging from donation to the clinical evolution of a recipient […]
SQA Regulatory Surveillance Summary | Monthly Update 2024
SQA Regulatory Surveillance Summary for Quarter 4, 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Joint Operation in Foz do Iguaçu Fights Illegal Import of Products Subject to Health Surveillance, 29 September 2023 ANVISA and the Federal Revenue Service carried out a joint operation in Foz do Iguaçu […]
SQA News | Fall 2023
Wins & Challenges October marked an incredible year since joining SQA Services. I regularly reflect upon how blessed I am to be a part of this organization. We are a mighty team providing indispensable services to many of the most influential companies in the world. Earlier this year, we took time as a leadership team […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023
SQA Regulatory Surveillance Summary for July and August 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Carries Out Health Inspection Actions in Food Supplement Industries in Rio de Janeiro, 10 July 2023 During the week of 12-16 June 2023, ANVISA and state and municipal health surveillance agencies […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June
SQA Regulatory Surveillance Summary for May and June 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Understanding the New Rules for Clinical Analysis Laboratories, 12 May 2023 ANVISA has updated the standards that deal with the technical requirements for the operation of laboratories that perform collection, examination, and […]
SQA News | Summer 2023
Wins & Challenges It’s hard to believe how quickly eight months have flown by at SQA. It has been such an amazing experience getting exposure to all our client’s challenges and successes. I have enjoyed seeing a broader spectrum of the industries from which I came, Aerospace and Energy, by observing how other companies are […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April
SQA Regulatory Surveillance Summary for March and April 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVSA Recommends Intensification of Actions Against Arboviruses, 22 March 2023 ANVISA has published Technical Note 12/2023 which recommends the intensification of measures or the reduction of mosquito breeding sites and control of […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – February
SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022. The document details the evaluation of […]