Paragraph III vs. Paragraph IV Filing in ANDA
When filing an Abbreviated New Drug Application (ANDA) with the …
When filing an Abbreviated New Drug Application (ANDA) with the …
In pharmaceutical development, dissolution testing plays a criti…
Reference Standard 1) Purity: Exceptionally high purity (often e…
Aseptic is defined as being “free from contamination caused by h…
In the world of pharmaceutical manufacturing, the environment in…
Standard Operating Procedures (SOPs) and Working Instructions a…
Biosimilar and generic drugs are both types of pharmaceutical pr…
Sterile in place (SIP) and clean in place (CIP) are two commonly…
What is the difference between? 1. First In, First Out (FIFO). 2…
Extractables and leachables are terms used in the pharmaceutical…
The differences between equipment and instrument based on ISO170…
What is the difference between quality and compliance in the pha…
When it comes to ensuring the safety and efficacy of pharmaceuti…
Waiting for the new version of ISO 9001 we can try to compare th…
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