Experts

Validation

James Agalloco is president of Agalloco & Associates, a technical service firm to the pharmaceutical and biopharmaceutical manufacturing industries. He has over 30 years of management experience in manufacturing, engineering, computer systems validation, technical services and research and development. He is also an internationally known expert on process and systems validation. He previously worked as worldwide validation and automated technology director for Bristol-Myers Squibb. He has a B.S. in chemical engineering from Pratt, and an M.S. in chemical engineering from the Polytechnic Institute of New York, as well as an M.B.A. with a specialization in pharmaceutical studies, from Fairleigh Dickinson University. He was a past president of the PFDA.

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An unusual reclaim process
Filled product is recovered from dose checks or improperly stoppered vials, is dumped into a holding tank, in a class 100,000 area, and once in the tank, it is pumped back to the main product holding tank. It is mixed with the product in the holding tank, refiltered and filled again during the course of the filling operations. Wouldn't this "reclaim process" be considered a reworking of the product? Unless this process was submitted along with the ANDA originally, and validated, it seems that this would not be following good cGMP practice for sterile filling operations. I don't think FDA or any other regulatory agency would find this to be an acceptable practice. What are your thoughts?
Category: Validation

Validation of QBD/PAT activities
My query is regarding the impact of “QBD/PAT” on Development Procedures: 1. What “Stability Studies Data” are expected by the regulatory agencies for a product/process developed through PAT/QBD? 2. What kind of Validation activities are proposed for the "established co-relation" between the "process parameters and composition of formula" with Product Quality Parameters?
Category: Validation

Superheated water or steam for sterilization?
What is the preferred means for sterilization of WFI vessels and distribution systems — superheated water or steam?
Category: Validation

Sampling of compressed gases
In the validation sampling of compressed gases, should I be concerned with microbial and particle counts? Should I sample with or without a filter present?
Category: Validation

Validating identical equipment
Is it possible to qualify/validate identical equipment so I don't have to perform three trials in each unit? If yes, how should I approach that effort?
Category: Validation