SQA Regulatory Surveillance Summary | Monthly Update 2023 – January
SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates of Documentation for Export of Active Pharmaceutical Ingredients (APIs) to the European Union (EU) and Certificate of a Pharmaceutical Product (No. 95, 2022), 08 November […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October
SQA Regulatory Surveillance Summary for September and October 2022 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022 ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. The 20-page Q&A document covers general and specific topics including the importation of cannabis products, […]
Field Engineering Blogs | PFMEA
By Gilberto Jimenez, SQA Senior Engineering Director PFMEA is a methodology for analyzing any sort of process. Some reasons to utilize this tool include when a process is being designed or redesigned, when control plans for a new or modified process are being developed, when improvement goals are planned, and when analyzing failures. The “P” […]
Regulatory Surveillance Summary for July 2018
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review […]
Why is Supplier Quality Important?
Imagine a customer approaching your store, a big smile on his or her face. The customer greets the doorman with a cheery “Hello!” and they exchange pleasantries. He or she enters the store, looking forward to a fulfilling trip. This person isn’t just another customer; this person is a patron who repeatedly returns to the […]
Supplier Quality Management Best Practices
To remain competitive, continuous improvement is necessary in all areas of a company. Too often, focus is kept on product development and customer service, and Supplier Quality Management is neglected after suppliers have been chosen. However, it is important to recognize the necessity of maintaining consistent standards of quality in all of the company’s current […]