Documentation Dosage forms

There are two specific guidelines on prolonged-release oral dosage forms (3AQ10a, adopted November 1992) and on modified-release products—oral dosage forms and transdermal dosage forms (CPMP/QWP/604/96, adopted July 1999). The advice in the two documents differs in a number of ways. 

This part of the chapter is based on consideration of the published EPARs at the EMEA s web site. At the time of writing there were more than 60 EPARs available. The contents of the pharmaceutical assessment section of each of these were examined, and detailed notes were made from more than 50 of those documents. The amount of information in the different EPARs varies considerably. Some have specific sections with the heading development pharmaceutics, while others include relevant information in the text without a heading. In some cases there are simple statements to the effect that satisfactory pharmaceutical development data were submitted. Therefore, an attempt has been made to glean information of a general nature, and this will be presented as a discussion of relevant topics by dosage form. 

CDER Guidance for Industry. SUPAC-IR Immediate-Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation US Food and Drug Administration, 1995. 

In contrast to vitamin and mineral products, which are chemically well-defined, the biopharmaceutical quality and behavior of botanical dosage forms marketed as dietary supplements are often not well documented. In most cases,... 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

FDA, September 1997, Guidance for Industry SUPAC-MR modified release solid oral dosage forms scale-up and post-approval changes chemistry, manufacturing and controls, in vitro dissolution testing, and in vitro bioequivalence documentation. 

SUPAC-SS Nonsterile semisolid dosage forms. Scale-up and postapproval changes chemistry, manufacturing, and controls in vitro release testing and in vivo bioequivalence documentation (May 1997). 

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