Author Archive

Authorities are on the defensive! This may provide an opportunity for a change for the better as well as to be heard regarding assessing the quality of pharmaceutical products.

A couple of days ago I read two recent articles, one from the US FDA [1] and the other from the USP [2], defending and rationalizing regulatory and pharmacopeial practices and standards for assessing the pharmaceutical products. These reports appear to be in response to the concerns often expressed regarding deficiencies in regulatory product evaluations. This article provides an alternate view of the issues and suggests a solution for the authorities’ consideration. Read the rest of this entry »

Impractically of risk-based approach to establish quality of pharmaceutical products and/or their manufacturing

In general to apply risk-based approach to establish quality of anything one would require a defined and measurable outcome/parameter. Once such an outcome/parameter is known or established then it is used to reflect chances of achieving success or failure of manufacturing or producing quality products. If the defined outcome/parameter is not available then it would not be possible to use risk-based approach for such. The manufacturing of the quality pharmaceutical products falls in this category i.e. there is no define parameter/outcome available for a “quality product”, thus risk-based assessment approach in pharmaceutical manufacturing is not possible at present.
To apply risk-based approach one would require to define quality pharmaceutical product with a measurable parameter. So, please seek a definition of a “quality pharmaceutical product” along with its measurable parameters using qualified and validated scientific methods. As an example please see here (

Quality – 2019 & beyond!

Hopefully the year in which “quality pharmaceutical products” will be defined along with their measurable standards/specifications so that manufacturers worldwide would be able to manufacture such products efficiently and economically. Please follow the link for more details (1, 2).

An interesting question about drug dissolution testing and simulation/modelling:

In the life cycle of drug product development several types of biorelevant dissolution data are generated (single stage, 2-stage, ASD etc.) to aid formulation development. These dissolution data are also used in PBPK models.

What type of in vitro biorelevant dissolution methods do you use as input in PBPK modeling?

Can there be a general decision tree on the use of types of biorelevant dissolution data in PBPK models for applications in formulation selection?

Very good question!
In this respect, one should make sure that apparatus/method used for dissolution testing purposes should be validated first. It is important to note that at present none of the apparatuses/methods have been validated. For validation purposes the apparatuses/methods are to be validated independently using a reference product with known dissolution characteristics which then should be applied to the test products. Scientifically validation cannot be achieved using products under development (

Should claims of quality of approved and marketed drug products be considered valid – not necessarily? Theranos’ style regulatory and pharmacopeial claims!

A product can only be considered of quality, and by extension safe and efficacious, if it meets specification(s) directly linked to a defined quality property/parameter. As, at present, a quality parameter for pharmaceutical products such as tablet and capsule, is undefined thus it is not possible to make valid claims in this regard.

Current regulatory and pharmacopeial approved products available on the market should only be considered as compliant to arbitrary standards/specifications, mostly invalid and irrelevant for quality. Claims are unsupported – a similar scenario as observed in the case of Theranos (link). Please use caution is making or accepting such claims, and seek appropriate help in addressing the issue (link).

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