Development Assurance process validation planning

It is interesting to note how PV and quality assurance (QA) have expanded to include not only technology transfer but also some of the development activity namely, PV associated with clinical supplies production. Another factor that has influenced the need to validate the manufacturing process is the involvement of the contractor, whose site has become the primary or alternate location for the sponsor to manufacture the clinical or commercial product. With this expansion it was inevitable that organizations would formalize the master validation plan as a building block of TQM. Furthermore, it is appropriate to include the validation plan for each clinical production process in the master validation plan. 

The D0178 inspired the ARP 4754 and D0254. Essentially, this is a classic approach of process assurance planning development activities (design, validation and verification, configuration management, as well as safety) to a certain quality standard and demonstrating that the process and the product meet the requirements stated in these documents. 

In summary, and at the risk of repetition, it must be stressed that the development of analytical methodology for the assessment of human exposure to pesticides is a complex process. Careful attention to planning of the research is of utmost importance. As much information as possible about transformation, storage and excretion of the pesticides of interest should be gathered. Preliminary work should focus on the analytical behavior of parent compounds and metabolites. The combination of these aspects with reliable analytical standards and a sound quality assurance program should yield valid analytical methodology. 

The pharmaceutical organization must develop a Validation Master Plan (VMP) to define the validation strategy for the implementation of the IS architecture. The VMP should address the process by which the pharmaceutical organization assures the quality of the products being procured and the strategy for validating the specific implementation of those products. 

The system validation documentation includes but is not limited to Quality Assurance Plan (QAP), Operation and Maintenance Manual (O M), and Factory Acceptance Test (FAT) reports. A properly developed QAP and its supporting documentation help to reduce cost, boost product quality, ensure regulatory compliance and increase profitability. The FAT validation is the first verification step of the customer s validation process, which may include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

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