Regulatory Focus™ > News Articles > New Guidance Provides Framework on How to Keep a Drug the Same over Time

New Guidance Provides Framework on How to Keep a Drug the Same over Time

Posted 21 February 2014 | By Alexander Gaffney, RAC

A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological products.


The guidance was last issued in final form in 1987-26 years ago-and in draft form in 2000.

Validation procedures and methods are important in the production of pharmaceutical products because they allow a company and regulators to say, with certainty, that a product meets pre-determined standards for potency, strength, quality, purity and identity.

FDA has cracked down on many manufacturers in recent years for failing to validate their materials, such as active pharmaceutical ingredients, before using them in their products. Failure to validate materials or the accuracy of a certification of analysis (COA) can lead to counterfeit or sub-standard products entering the supply chain.

But even at a more basic level, if methods and procedures are not properly validated or configured, even a well-intentioned company that does conduct testing on its products can be left with false assurances of a product's characteristics.

Updated Guidance

Hence, FDA's new guidance, Analytical Procedures and Methods Validation for Drugs and Biologics.

The main takeaway is this: Analytical procedures and methods for drug and biological products subject to a new or generic drug applications (NDA, ANDA or BLA) need to be validated to FDA.

"Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy and reliability and are suitable for their intended purpose," FDA explains in the guidance.

Once approved by FDA as part of the application, that procedure or method is then FDA-approved for that purpose, and the company must follow it. Deviations from that procedure or process must be re-approved as part of a supplemental process (often a prior approval supplement or a changes being effected filing).

Luckily, companies don't always have to make these processes up themselves. FDA notes that the US Pharmacopeia and National Formulary both maintain validated procedures that can be used in support of testing that have already been validated as being fit for purpose. Those reference standards can be incorporated with relatively little trouble.

But should it need to, FDA's guidance goes into all of the steps a company should take when developing and validating analytical procedures and methods, as well as their maintenance over time and throughout changes.

Comments on the guidance are due by 20 May 2014.


Analytical Procedures and Methods Validation for Drugs and Biologics

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