There is no doubt that regulatory authorities worldwide are facing numerous challenges in establishing efficient availability of quality pharmaceutical products, in particular tablets and capsules. It appears that a lack of clarity of objective/mandate may be the main cause of the problem and, by extension, the reason there are difficulties in addressing these. The following suggestions maybe considered in addressing the current challenges.
- If the objective is to facilitate bringing quality products to patients, which indeed is the objective. In that case, authorities should establish a definition of “quality products,” providing a reference quality product with associated measurable quality parameters. No one can manufacture and/or evaluate a quality product without a definition. A suggested definition in this respect is provided here.
- On the other hand, if the objective is monitoring the manufacturing quality, which appears to be the main emphasis of current regulatory practices (cGMP etc.). Then, authorities should not be in this business because this is neither their mandate nor they possess competency/expertise in the area. Moreover, they have never developed or manufactured products or run or maintained cGMP manufacturing facilities for commercial purposes. It would, therefore, be impossible to evaluate or guide the industry adequately to establish or run efficient manufacturing facilities.
It is hoped that these suggestions will be given favorable consideration.