Product design solid dosage forms

How does the team characterize the process for which the pilot plant is to be manufactured The first question that needs to be answered is What is the ultimate goal for the facility Is it to support development for solid dosage forms, liquid products, or biologically derived products Or does it have to serve multiple functions The answer to this question will allow us to focus and generate more accurate plans. Until later on in the design phase, this process characterization should be kept broad and not very detailed. Included in the evaluation should be the ancillary service equipment and support services, such as electrical and air handling requirements. 

Fig. 3 shows a pilot plant layout with restricted personnel access. This design would support the development and clinical manufacture of solid dosage forms, liquids, semisolids, aerosols, and sterile products. Multipurpose rooms are incorporated in each area to maximize the use of portable equipment, and scale factors similar to those shown in Table 1 are employed. Isolation suites are indicated in the manufacturing area their purpose and design are discussed in more detail later. The sterile area is isolated from the main corridor by the interior corridor design. At the far left, the main corridor provides access for future facility expansion, if necessary. 

The design of stability studies to support submission of NDAs and MAAs are described in the ICH Guidance QIA (R2) Stability Testing of new E>mg Substances and Products (3). The sections relevant to solid dosage forms are described below. 

The plant is designed to produce oral solid dosage forms as well as liquid dosage forms, ointments, creams, suppositories, and sterile injectable products. 

Storage under conditions of high relative humidities applies particularly to solid dosage forms. For products such as solutions, suspensions etc., contained in packs designed to provide a permanent barrier to water loss, specific storage under conditions of high relative... 

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