Facilities validation

Facilities validation is related to the location, design, and construction of the plant to facilitate cleaning, maintenance, and operations in order to be appropriate for... 

All facilities in a pharmaceutical industry must be designed and validated in order to assure the minimum risk of cross-contamination. Facilities validation must include the products and personnel flow, rooms design and cleaning, air and humidity systems, and water pipelines. 

Facilities validation is a critical process in a pharmaceutical industry and the types of pharmaceutical forms produced must be considered. Facilities that produce different pharmaceutical forms have different specific requirements and different critical parameters based on risk assessment. All facilities must have an adequate flow of people, raw materials, bulk products, and finished products. These flows must be created in order to avoid cross-contamination. Additionally, pressurized rooms and adequate SOPs should be supplied to minimize the risk of cross-contamination. Controlled air temperature and humidity are also required and should be validated to ensure adequate stability of the product. 

Falkow, M. Overview of a new facility validation effort. Eighth Annual ISPE/FDA Joint Conference, Case Studies in Validation. March 14-16, 1989. 

Equipment, cleaning, and/or facility validation requirements Process validation criteria... 

We have briefly discussed different contracting options. The API manufacturer has to decide how to procure the outside services necessary to accomplish these steps. We cannot recommend any one method as better than another. The contracting decisions must be made based on all party s relative strengths in the execution of this type of project. If the decision is to contract out the entire process to one firm in an EPC contract, the outside firm is expected to deliver a completed facility, validated and ready to produce product. 

The same arguments can be applied to other energetically facile interconversions of two potential reactants. For example, many organic molecules undergo rapid proton shifts (tautomerism), and the chemical reactivity of the two isomers may be quite different It is not valid, however, to deduce the ratio of two tautomers on the basis of subsequent reactions that have activation energies greater than that of the tautomerism. Just as in the case of conformational isomerism, the ratio of products formed in subsequent reactions will not be controlled by the position of the facile equilibrium. 

In the course of assessing your company s current PSM status, you and your team have almost certainly gained a clear sense of which facilities pose the greatest risk, whether by virtue of inherent process hazards, human factors, management systems, or a combination. As you set priorities for implementation you should closely review information gleaned from the assessment tasks. In addition, you should try to validate or flesh out your impressions through some more quantitative analysis that can help to identify priority facilities. 

If the answer in both cases is "yes," then consider the locd climate. Local cooperation—or lack of it—may he the single most important determinant of site selection, since without it you cannot field a valid test. However if you have kept facility managers informed or involved as the PSM process has gone forward, you should have some ideas about which of them would be par-ticulariy enthusiastic—or otherwise. In addition, having identified site-specific benefits may help you win the support of a manager who might otherwise be reluctant to participate. 

Lessons Learned. It s very early in the game to make predictions about what changes may be needed as a result of the Manwood test. However, there are already some useful insights that the Task Force expects to factor into the PSM installation plan for the division. These include 1) We need to be very clear in introducing PSM to our employees, and take time to answer their questions. Orientation meetings should be at least 90 minutes, not the one hour we had scheduled. 2) Getting valid feedback takes some effort personnel need to know we mean it when we say we want constructive criticism. 3) Close collaboration between the Task Force and the facility manager is absolutely vital. 

The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 

---