Plan development General Section

The operations group will develop general operating and maintenance objectives for the facilities which will address product quality, costs, safety and environmental issues. At a more detailed level, the mode of operations and maintenance tor a particular project will be specified in the field development plan. Both specifications will be discussed in this section, which will focus on the input of the production operations and maintenance departments to a field development plan. The management of the field during the producing period is discussed in Section 14.0. 

The iiifornialioii from Tier II and on-site inspections should help the local fire department in the development of prefire plans. Tlie information submitted by facilities midcr Sections 311 and 312 must generally be made available to tlie public by state and local govermneiits during normal working hours. 

Proper and comprehensive planning of a clinical trial is essential to the successful development of any drug. Clinical trial design is a subject whose scope is too broad to be undertaken in this text, and only a brief overview of the subject is presented below. The interested reader is referred to the Further Reading section at the end of this chapter. The general principles presented below are relevant to phase II, and particularly phase III, clinical trials. As the bulk of the estimated 300-500 million required to develop a drug is spent on clinical trials, a poorly planned and/or executed clinical trial can be very costly to the drug developer. 

Future Plans The future plans section should include specific plans for the next 12 months and a more general outline of the complete drug development plan. While this outline may not change (or may be revised) from year to year, it should be incorporated each year as a yardstick for progress. 

The protocol is a written document (see Section II.C.I) that describes the necessary parts of a stability study. It details the basic plan that will be executed, and its two major components include the tests to be performed and the schedule of testing that is planned. The types of batches that require a protocol are clinical, formulation development, registration, and marketed product. In addition, compatibility of a product with a vehicle (e.g., an injectable product in an intra venous saline solution) is often studied to support the use of injectable products for hospital use. Probe stability studies are generally more experimental in nature and may not be suitable for a formal written protocol. 

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