Case Study: Product Recall due to labeling error
In the pharmaceutical market we find many cases where product recall takes place due to labeling error. Here is an example. Company XYZ is voluntarily... Read More
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What is a Stability-indicating assay method?
Posted on21 Feb 2024
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A stability-indicating assay method is a type of analytical technique used in pharmaceutical analysis to determine the stability of a drug substance or drug product... Read More
What are the difference between Wholesaler and Specialty Pharmacy?
Posted on21 Feb 2024
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There are clear cut difference between the two terms. The wholesalers are the first purchaser of the drug, directly from manufacturer. Specialty pharmacy involves in... Read More
Case Study: Backward integration in Pharmaceutical Business
Posted on21 Feb 2024
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Backward integration refers to the process in which a company purchases or internally produces segments of its supply chain. In other words, it is the... Read More
A case based understanding in co-development deal
Posted on21 Feb 2024
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In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well, the two partners together jointly... Read More
Case analysis: 483 observations – Data Integrity issues in a pharmaceutical finished dosage formulation plant
The US Food and Drug Administration has pointed out data integrity lapses at XYZ Pharma’s finished dosages plant at <Location>. The FDA issued Form 483... Read More
What is the difference between 505j application, 505b1 NDA & 505b2 NDA?
In this topic we will be discussing about 505j, 505b1 and 505b2 application and differences between all 3 applications. The 505(j), 505(b)(1), and 505(b)(2) applications... Read More
What is an audit trail?
An audit trail is a chronological record of events or actions that have occurred within a system or process. Audit trail means a secure, computer-generated,... Read More
What are the difference between FDA 483 and Warning Letter?
483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and Warning Letter. Let... Read More
What is Biologic License Application (BLA)?
A Biologic License Application (BLA) is a submission to the USFDA requesting permission to market and distribute a biologic product. Biologic products are therapeutic agents... Read More
What is difference between Form 483 and Establishment Investigation Report ?
Form 483 and an Establishment Investigation Report (EIR) are both documents used by regulatory authorities, particularly the U.S. Food and Drug Administration (FDA), but they... Read More
What is Design of experiments (DoE) approach?
Posted on21 Feb 2024
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Design of experiments (DoE) is a systematic approach aiming to maximize information content from an experimental study, while keeping the number of experiments low. During... Read More