Blog
Pharmaceutical Drug Development: From an Idea to The Market
Have you ever wondered about the long and arduous journey that a drug goes through before coming to pharmacy stores? Overview The journey begins in a laboratory where researchers, spending hours and hours to understand the processes behind a disease and stumble upon a...
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,...
Quality by Design Approach to Product Development
It is a simplistic analogy, think of formulation and process development in terms of developing the recipe for a cake. The result should mimic a packaged cake mix, which includes or lists all the ingredients required and provides complete yet simple instructions. By...
Knowledge Management in Formulation and Process Development
In the development of a dosage form for a new or generic chemical entity, a formulator generally relies on his past experiences to assist him in making decisions. These past experiences can vary with the knowledge and experiences of each individual formulator. ...
Distribution Stability Studies
These studies are designed to complement pre-formulation and routine ICH Q1A Registration Batch Stability Studies. ICHQ1A states that the data from accelerated stability studies can be used to evaluate the effect of short-term excursions higher or lower than label...
Developing a Control Strategy for Your Product
Control Strategy is a critical concept in formulation and process development and the manufacture of a drug product. The control strategy plays an important role in ensuring that the Quality Target Product Profile (QTPP) is realized and the Critical Quality Attributes...
The Relationship among the Date of Manufacture, In-process Hold Times and Drug Product Expiration Date
Extended in process hold times for drug product intermediates could have an overall impact on the commercial ‘shelf-life’ (not expiry date) of your product. Establishing Date of Manufacture According to FDA, a 30-day period from the Date of Manufacture to...