When the FDA Inspector visits your firm, What are the Chances of a Really Bad Outcome?

It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner.

To ensure compliance with regulations, the FDA conducts inspections of all registered establishments. 

Once the inspection is closed out, it is categorized in one of three ways based on the objectionable conditions noted (if any):

NAI - No Action Indicated

VAI - Voluntary Action Indicated

OAI - Official Action Indicated

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 8)

Requested By: for KVR Sudhir
Organization: Pharmaceuticals
Category : Parenterals

Questions

A.     VIAL WASHING  MACHINE QUESTIONS

1. What is purpose of vial washing machine?

Objective: Cleaning of Vial externally and internally to reduce the bio-burden.

Note:  It is used as a primary packing material.

HVAC Control and Monitoring System Validation

The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated.

PQ protocols covering this system, in general, include the performance challenges for the all the components of the environmental control system described in the foregoing. The system is challenged by simulating the process or at the time the aseptic processes qualification

or media fills are performed.

The validation protocols follow the same format structure outlined before for the architectural components.The following section provides a generic checklist approach used for the HVAC controls and monitoring systems validation. As indicated earlier, the HVAC systems could be either manually, electric, pneumatic, or electronically controlled, operated or monitored. Computer- or microprocessor- controlled equipment is subject to the software and hardware validation procedures that apply to computerized systems.