Solid dosage forms, manufacturing guidelines

FDA Guideline, SUPAC-IR/MR Immediate and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, draft guidance, April 1998. 

The guidelines contained within this chapter should be considered as part of a comprehensive validation program for solid oral dosage forms. The unique formulation or process characteristics of a particular product and the equipment available to manufacture that product may dictate the need for a specialized validation program. As such, the multidisciplinary validation team must identify the product and process characteristics that must be studied and incorporate specific validation tests to ensure that that product will meet all quality, manufacturing, and regulatory requirements. 

FDA Guideline, SUPAC-IR, Immediate Release Solid Oral Dosage Form Scale-Up and Post-Approval Changes Chemistry, Manufacturing and Controls, in vitro Dissolution Testing, in vivo Bioequivalence Documentation, CDER, November 1995. 

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