Multi-Unit Pellet Systems (MUPS)
1. Introduction Solid dosage forms are the most frequently used drug delivery systems (DDS) for oral administration. They differ drastically in size and number of units administered as a single dose, including both single-unit dosage form (SUDF) and multiple-unit dosage form (MUDF). Multi-unit pellet system (MUPS) is one of the most popular MUDFs because of
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Tracebility Standards Process In Quality Control Department Of Pharmaceutical Manufacturing
1. Common definition(s) Primary Standard (primary standard): A standard of the highest purity, having the important properties fully validated and widely recognized, of suitable quality under specified conditions, and having a recognized value acceptable without having to compare it with another standard. Reference standards: including pharmacopoeial standards and non-pharmacopoeia standards (basic standards provided by the
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Mean Kinetic Temperature – MKT
1. Introduction Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy and safety of a drug product. In 1971, J.D. Haynes calculated a “Virtual Temperature” to predict product expiration when considering temperature variability in a given region. The formula uses the Arrhenius
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Comparing Attributes of the ASEAN Medical Device Directive and EU 2017/745 Regulation (Session 1)
When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements that apply to them and their machines. As medical device regulators evolve their regulatory frameworks in a particular jurisdiction, they look for solutions to challenges they face from other
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Scientific Conference: “Quality Management By Cloud Computing: Comprehensive Solution Through MasterControl Application.”
Today, Friday, February 24, 2023, the seminar program “Quality management by cloud computing: Comprehensive solution through Master Control application took place with the participation of more than 20 companies manufacturing activities in all fields, including 14 large and small pharmaceutical companies in Vietnam. Speaking at the workshop, Mr. Dinh Hoang Anh, Chairman of Orioled Hub,
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Transfer Of Analytical Methods Between Two Units And Laboratories
At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical methods to improve product quality as well as bring domestic technology to ensure fast and sustainable development. Before an analytical method is transferred, it should be properly developed and
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Orphan Drug Designation
An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare disease (affecting less than 200,000 patients in the United States and/or 500,000 patients in the European Union). What does it mean to be granted orphan drug designation? Orphan drug
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Pharmaceutical Quality System (PQS)
Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in accordance with the Marketing Authorisation. To ensure this, the PQS is utilized. Adequate resources (locations, equipment, and employees), a sound quality policy with appropriate quality targets, and documentation of
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Workshop On “Exchange Of Experience In Upgrading The Quality System Of A Pharmaceutical Production Facility To EU – GMP Standards” By OrioledHub And Equilab
On the morning of November 24, the Workshop on “Exchange of experience in upgrading the quality system of a pharmaceutical production facility to EU – GMP standards” by OrioledHub and Equilab in collaboration with brothers and sisters from 12 factories operating in the field of Pharmaceutical Manufacturing in Vietnam. The workshop discussed and shared together
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Internal Training Course On Pharmaceutical Overview For Non-Pharmaceutical Staff
Last week, with the excitement of the trainees, the training course “Overview of Pharmacy” hosted by OHI Research Institute ended with hot certificates given to each trainee. The majority of the students met the standards of attending a sufficient number of classes and having the results of the “Pass” test. Congratulations students.With the goal of
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