Documentation during development

Decide on the conventions to be used in identifying the issue status of design documents during development and following design certification. 

TABLE I Analytical Documentation Key Product-Specific Documents during Development... 

In addition, you may also want to revisit some of the flowcharts and other documentation you developed during systems design (Chapter 6). Training. Pilot participants must be properly trained otherwise the results of the pilot can be veiy misleading. Don t assume that you can defer training until later or that it doesn t pay to invest in training just to do a pilot. 

The validation umbrella not only covers in-house systems, but also covers vendor systems. Much of industry today is dependent to some extent on vendor-supplied electronic systems and, consequently, the vendor s validation of those systems. Because of this, there are validation issues to assess at the vendor including how the vendor addresses change control, testing and documentation, source code, integration, and implementation of the system during development. Implementation support also must be assessed. 

The activity of the malate-aspartate shuttle increases during development in parallel with synaptogenesis, which is consistent with the high activity and importance of this shuttle in neurons and synaptic terminals. Evidence of highly regulated malate-aspartate shuttle in adult human brain has been documented [73 and references therein]. 

Much of the process knowledge and documentation is developed through the earlier life cycle stages of a facility. Most of these components need to be retained or kept up to date during the entire facility lifetime. 

Ensure that training modules and training sessions for production, engineering, and support personnel have been developed, conducted, and documented during this stage... 

System design specifications will be used by the supplier as working documents during the design, development, integration, and build of the system, and after qualification of the system as support documentation by those responsible for the maintenance and future enhancement of the system. 

Controls, alarms, and interlocks. The performance of the controls, alarms, and interlocks that were developed in the IQ must be observed and assessed, and the results must be documented during a simulated production ran. For controls that do not function during routine operation, a manual intervention may be used. 

Approval of the regulatory filing is influenced by the documentation efforts put forth during development. 

Some products have specific control requirements for the environment, as indicated during development. Relative humidity, temperature, and even light-level restrictions are parameters that may need to be controlled. If there are control requirements, they should be indicated in the batch record. Documenting the actual results of environmental conditions should be a requirement of the batch record. This can be accomplished by either routine monitoring with a calibrated instrument and then recording these results on a log sheet or by attaching data generated by a recorder (e.g., strip chart, circular chart). 

Maintain documentation on any problems encountered during development and steps taken to overcome those problems. 

Maintain documentation on critical steps and parameters identified during development. 

An FDA investigator will identify both procedural critical control points and critical parameters in formulation that are delineated in this report and proceed to inspect these areas. Appropriate documentation and management of changes to critical parameters and critical controls is essential during development. If there is ever a time that change is welcomed and constant, it is during development. 

Ms Valerie Rolland (during development of the public review draft of the document) Assistant Scientific Co-ordinator, Scientific Committee, European Food Safety Authority, Parma, Italy... 

Little regulatory guidance was in place during development of the early recombinant human enzymes. Ceredase and Cerezyme were developed in the absence of the ICH S6 document, and therefore safety packages for these enzymes were a combination of traditional safety studies as well as specific... 

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