Author Archive

Compliance/guidance-based regulatory system and products safety and efficacy assessment

Safety and efficacy of the pharmaceutical products (e.g. tablet/capsule) can only be established by determining quality of the products. If quality of the products cannot be established, as currently is the case, then claims of safety and efficacy cannot be made either. In addition, as compliance does not necessarily equate quality, safety and efficacy cannot be achieved by compliance as well. Use caution in promoting or accepting such claims. Quality of the products, and by extension their safety and efficacy, has to be defined and determined independently.

Please seek definition of the quality of the pharmaceutical products in terms of a quantifiable parameter to substantiate claims of safety and efficacy. For further details the following links would be useful (123) .

Validation – what it really means!

It is really hard to believe or accept how people have been blind-sided with “validation” (re-validation, continued validation etc.) requirement. The simple fact is that to run validation for any process one requires a reference product or parameter to show that process is validated (or capable of providing an expected outcome or product). If one does not have a reference product with known parameter and its value, then it is impossible to validate anything. Please, people this is logic and science 101.

If anyone is requiring or conducting validation without a reference (as in the case of current practices of manufacturing of quality pharmaceutical products in particular tablet/capsule), then validation of such manufacturing processes must be considered as “abracadabra” practices commonly accepted as meeting the “compliance”, “harmonized standard” etc. and do not link to quality aspect of the process or product.

I hope authorities, including pharmacopeias, will work in addressing these bizarre trends of validation approaches/concepts currently in practice and/or required, which have no scientific and/or logical basis.

Please, define a quality product and then provide a reference product which would allow the manufacturers to meet or exceed the standards of quality.

Revision of the USP General Chapter <1058> – a credibility issue!

Whenever one would like to evaluate a pharmaceutical product such as tablet/capsule, a commonly accepted approach is to seek a test described in the USP. The reason being that the tests described in the USP are being promoted and considered as references for products testing. The USP often provides seminars and hands-on training describing these tests (e.g. drug dissolution) and their validations. The regulatory authorities world-wide enforce the standards described in the USP monographs (see e.g. US FDA dissolution methods database, considering that the methods and associated instruments described in the USP are adequately and independently qualified and validated.

With the revision of the USP General Chapter <1058>, however, this situation appears to have changed ( In the revised Chapter it is described that the users are responsible for the qualification, and by extension validation of the instruments. This may not be a true representation of the practice. If this would have been the case then instruments would have to come with the users’ reference as to who performed the qualification (as well as how), and on what basis the instruments have been included in the USP. In reality, vendors and users promote manufacturing and the use of these instruments, respectively, by making claims that instruments manufactured or used are as per “USP specifications”, not those of their own qualification or validation standards. Obviously, this revision of the USP chapter is unusual and in error and might impact negatively on USP’s credibility as a standard setting organization for quality assessment of pharmaceutical products.

If the issue is with a certain specific type of instruments such as drug dissolution, which are known to be non-qualified and non-validated, then a more appropriate approach would be to remove such instruments from the USP rather than creating doubts about the qualification/validation of all instruments and associated methods described in the USP.

It is my view that the revision of the Chapter is not in line with the USP objectives and practices, and the decision may have been taken in haste, therefore, requiring reconsideration.


Another link/article on the same topic – A must read! Drug dissolution testers: “A modern-day mystery” – Are people being fooled by promoters of (paddle/basket) dissolution testers? It appears so! (Link).

USP’s Instrument Qualification U-turn: A new headache for the industry and regulators and a possible solution

Recently USP revised General Chapter <1058> [Analytical Instrument Qualification (AIQ) - 1, 2].  Generally it is recognized that instruments described in the pharmacopeias (e.g. USP) are suitable and qualified for their intended purpose so laboratories/industry may use these with confidence as per recommended specifications. In addition, instrument manufacturers provide such instruments meeting or exceeding the recommended pharmacopeial specifications. However, with the revised Chapter <1058> this situation has changed. Read the rest of this entry »

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