Drug Product Quality

Drug Product Quality

Introduction Drug Product Quality is a term one should be familiar with as part of routine drug development and manufacture. Recently while working with a small pharmaceutical company and their contracted development organization, an Incident Report documented the...
Drug Development Lessons Learned

Drug Development Lessons Learned

The discovery, development and commercialization of a novel drug entity is not a quick or easy endeavor. Many compounds fail during safety and/or clinical testing for a variety of reasons. In addition, the compound may demonstrate chemical or physical characteristics...
Document Retention

Document Retention

Keeping track of data, development reports and other important documents for a given project for potential future need is always a concern for companies. Individuals working on a project may change; some will leave for other opportunities, and individual’s memories...
Manufacture, Retest and Expiry Date Revisited

Manufacture, Retest and Expiry Date Revisited

Several years ago, I wrote about the relationships among date of manufacture, in-process hold times and drug product expiration date. Since then, there have been some developments that are worth revisiting. The corresponding guidelines of EMA (The European Medicines...
Botanical Drug Development

Botanical Drug Development

Introduction   The use of plants as to treat various human maladies has been known since ancient times.  Many of today’s drug products contain plant-derived ingredients.   Botanical products may be classified as foods, dietary supplements, drugs, medical devices,...

Formulation and Process Development

Formulation and process development can be a complex and a time-consuming effort. It can take months depending on the physical and chemical properties of the active pharmaceutical ingredient and the complexity of the dosage form being developed. To assist companies...

Pharmaceutical Mixology

The blending of different ingredients together in a uniform mixture is one of the most basic of pharmaceutical unit operations, but it can also be one of the most challenging to control. The terms ‘blending’ and ‘mixing’ are often used interchangeably, but...

Drug Substance Starting Materials

Starting Materials are the building blocks by which drug substances are assembled.  Starting Materials must consistently meet their specifications. However, Starting Materials do not need to be prepared in compliance with GMPs. There are no absolute requirements for...

NDA Stability Data

In submitting stability data in a NDA, there is the primary data which are generated on the drug substance and drug product prepared by the proposed commercial synthesis/process and proposed commercial formulation/manufacturing process, respectively. In addition,...