The current view of the world’s regulatory authorities is that Process Validation (PV) demonstrates the adequacy and robustness of the manufacturing control strategy and gives continuing assurance that the process is under control. It is defined in the November 2016 EMA Guideline on process validation as: “Process validation should not be viewed as a one-off
Human Resources covers multiple functions besides general HR (Recruitment, C&B, T&D), and the value that HR professionals add to the business reaches far and wide. You can provide general advice to your business, support the implementation of technology or other digital initiatives, build and maintain a healthy organizational culture, or strategically integrate the HR value
Research and development of many new drugs open up treatment opportunities and change the lives of millions of patients. However, developing and manufacturing new drugs is a very difficult process, requiring a lot of research time, equipment, resources, and huge costs. 1. More than a decade path for a new drug to be born Every
The following article provides information, overview data and latest trends about the intraocular lens market imported to Vietnam. The data provided in the article is based on Big data of Orioledhub. A. MARKET OVERVIEW An Intraocular Lens implant (or artificial lens implant) is a synthetic lens placed inside the eye that replaces the focusing power
EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with the Marketing Authorisation Holder (MAH). The MAH must have appropriate controls in place and operate a Quality Management System to support the activities related to these controls. So,
1. Introduction Documentation is an essential part of the quality assurance system and proves that the GMP-relevant activities are carried out in a proper and timely manner. All relevant information is recorded clearly and in full so that the errors in interpretation or oral communication are minimized. Documentation reflects the planning, control, and evaluation of
The Institute of Pharmaceutical Technology was established by Orioled Hub company and recognized by the Department of Science and Technology of Ho Chi Minh City in August 2022. Headquarters: 72 Binh Gia Street, Ward 13, Tan Binh District, Ho Chi Minh City. Director: Mr. Pham Ngoc Vien Linh Senior Advisor: Dr. Le Minh Quan, PhD
The below contents do not contain the full and detailed information of the circular, but the information is extracted and summarized as a part of the circular on classifying functional foods including supplemented foods, health protection foods, medical foods, and foods used for special dietary uses. Circular 43 classifies functional foods into 4 main groups
Before any product can be sold within the European market, it needs a market authorization (MA) from European Medicines Agency (EMA). Once a medicinal product gets MA from the European Medicines Agency (EMA), it is ready to be sold in EU. However, the Marketing Authorization Holder (MAH) must follow some mandates: The medicinal product must
