Add to ORKGThe manufacture of injectable pharmaceuticals presents challenges from many perspectives, especially for products that must be processed aseptically and cannot be terminally sterilized. Food and Drug Administration (FDA) inspections for Good Manufacturing Practice (GMP) compliance in injectable drug product manufacturing facilities commonly find problems in the following area
The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure th...
The handling of medications is a parkour wired with complications in the preparation, administration...
Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from t...
Background: To date there exist no internationally recognised Good Manufacturing Practices (GMP) th...
The manufacture of injectable drugs imposes special requirements to minimize the risk of microbial a...
It is recognized that any contamination control strategy represents a cyclical process, designed to ...
The modern pharmaceutical industry is a strictly controlled area. Both national and international ru...
Good manufacturing practice (GMP) is a cornerstone in the regulated production of pharmaceuticals. A...
INTRODUCTION Highly active or sensitising ingredients (API/SI) need special rules for their product...
Background. Cross-contamination and mix-ups arc among the problems which could have a negative impac...
Injectable protein-based medicinal products (drug products, or DPs) must be produced by using steril...
In the highly regulated pharmaceutical industry, significant risks to products/processes must be for...
Homeopathy is a system of medicine based on the application of the principle of therapeutic similitu...
Physicians are usually focused on which drug to prescribe, but recent developments suggest that they...
CAR-T Cell Therapy manufacturing processes require handling of small volume process and product comp...
The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure th...
The handling of medications is a parkour wired with complications in the preparation, administration...
Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from t...
Background: To date there exist no internationally recognised Good Manufacturing Practices (GMP) th...
The manufacture of injectable drugs imposes special requirements to minimize the risk of microbial a...
It is recognized that any contamination control strategy represents a cyclical process, designed to ...
The modern pharmaceutical industry is a strictly controlled area. Both national and international ru...
Good manufacturing practice (GMP) is a cornerstone in the regulated production of pharmaceuticals. A...
INTRODUCTION Highly active or sensitising ingredients (API/SI) need special rules for their product...
Background. Cross-contamination and mix-ups arc among the problems which could have a negative impac...
Injectable protein-based medicinal products (drug products, or DPs) must be produced by using steril...
In the highly regulated pharmaceutical industry, significant risks to products/processes must be for...
Homeopathy is a system of medicine based on the application of the principle of therapeutic similitu...
Physicians are usually focused on which drug to prescribe, but recent developments suggest that they...
CAR-T Cell Therapy manufacturing processes require handling of small volume process and product comp...
The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure th...
The handling of medications is a parkour wired with complications in the preparation, administration...
Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from t...