Validation of Oral/Topical Liquids and Semisolids

The term “validation” can have differentmeanings within

the scope of the healthcare industry. For example, from the

research point of view, this term can pertain to the efficacy

of a drug therapeutic effect, or effectiveness of an auto-

mateddiagnostic assay, aswell as the instrumentation and

software used to obtain the result. The predominant use of

the term is with reference to manufacturing operations

and direct supporting systems. The scope of this chapter

will be the compliance requirement for the validation of

manufacturing processes for oral liquids and topical

semisolid pharmaceutical dosage forms. This is generally

referred to as process validation and begins with the

batching of approved raw materials to the storage and

shipping of packaged product. The term “PQ” has been

used to describe some of the concepts presented in this

chapter. The variety of formulations that fall within the

scope of this chapter will be surveyed along with associ-

ated manufacturing equipment. The chapter will be

directed toward the individuals charged with the respon-

sibility of preparing and executingvalidationprotocols for

these dosage forms. The assumption will be that develop-

ment is essentially complete; however, a few of the

common process problems will be discussed with the

hope that the reader will be able to anticipate pitfalls and

eliminate subsequent validation difficulties.