The United States FDA has just issued a new
Guidance for Industry: Process Validation: General Principles and Practices
This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register.
Our initial observations at Sibaya LifeScience! are:
Aligning process validation activities with the product lifecycle concept and with existing FDA guidance, this guidance now includes biological products and active pharmaceutical ingredients.
It also specifically provides recommendations with the Risk-Based Approach for technological advances in pharmaceutical manufacturing.
It clearly defines process validation ‘as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products’
From our perspective one of the most interesting guidance points is the consideration of having an integrated team composed of a variety of specialties to cover process knowledge, facility design and equipment selection among others.
The full text is available from the FDA or it is available as a PDF file from their site.
We would be interested in your views which you can add below by clicking on the comments link.
Can you expand on what your interpretation is of “integrated teams”. Do you think this would also include third parties?
Is this FDA guidance is different from the FDA guidance for industry which consider the BUA(Blend uniformity Analysis) and DUA (Drug Uniformity analysis ) ?
The guidance which considers the BUA and DUA is the guidance for industry called “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment”
This guidance is intended to assist manufacturers of human drug products in meeting the requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to ensure uniformity of in-process powder blends and finished dosage units. This guidance describes the procedures for assessing powder mix adequacy, correlating in-process dosage unit test results with powder mix test results, and establishing the initial criteria for control procedures used in routine manufacturing.
In other words, sampling and testing of in-process materials and drug products shall be covered and conducted with written procedures to assure uniformity and homogeneity.
As the guidance for industry called “Process Validation: general principles and practices” incorporates principles and approaches that all manufacturers can use in validating a manufacturing process:
* Quality, safety, and efficacy are designed or built into the product
* Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.
* Each step of a manufacturing process is controlled to assure that the finished product meets all design characteristics and quality attributes including specifications.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.