The Lifecycle Approach to Process Validation: Overview
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
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T-Shape & Business Acumen – Core Competences And Values Of HR Professionals
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
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How Is A Drug Manufactured? New Drug Research And Development Process
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
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Summary of intraocular lens market information in Vietnam 2021-2022
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
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Chirty In Chau Thanh, Ben Tre
Yesterday, September 4, 2022, TV TPI cooperated with the Red Cross Society of Tan Binh District to give 50 gifts to disadvantaged students from poor households in Chau Thanh town, Chau Thanh district, Ben Tre province. The students from elementary to high school, with innocent eyes, but also full of joy and excitement because they
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Marketing Authorisation Holder
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,
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Overview of GMP Documentation
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
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Happy Birthday TV TPI
Today, TPI TV has turned 7 years old, the process is not too short nor long but enough for TPI TV to gradually mature and become more stable. Over the past 7 years, the number of members in the TPI TV family is increasing day by day, people come and go, but they all contribute to making TPI TV stronger and constantly innovating as it is now.
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