By Sarfaraz K. Niazi
The fourth quantity within the six-volume instruction manual of Pharmaceutical production Formulations, this booklet covers semi-solid medicines. It comprises ointments, creams, gels, and suppositories, from publicly to be had yet generally dispersed info from FDA New Drug purposes (NDA), patent purposes, and the BASF ebook of frequent formulations. each one access starts off with a completely confirmed scaleable production formulation that comes with compendial specification requirement for every factor, in-process controls for production and liberate of product, a precis of producing method, and info of packaging
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Additional resources for Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (Volume 4 of 6)
For example, a change from a planetary mixer to a dispersator mixer demonstrates a change in operating principle from low-shear convection mixing to high-shear convection mixing. These types of equipment would be considered different under SUPAC-SS. Applicants should carefully consider and evaluate on a case-by-case basis changes in equipment that are in the same class but different subclasses. In many situations, these changes in equipment would be considered similar. For example, in Section III, Mixing, under the convection mixers, low shear, a change from an impeller mixer (subclass) to a planetary mixer (subclass) represents a change within a class and between subclasses.
Temperature and humidity) and controls, and personnel common to both manufacturing sites are used, and where no changes are made to the manufacturing batch records, except for administrative information and the location of the facility. “Common” is defined as employees already working on the campus who have suitable experience with the manufacturing Postapproval Changes to Semisolid Drugs process. , temperature and humidity) and controls, and personnel common to both manufacturing sites are used, and where no changes are made to the manufacturing batch records, except for administrative information and the location of the facility.
Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage 2. Change in, or addition of, pharmacoeconomic claims based on clinical studies 3. Changes to the clinical pharmacology or the clinical study section reflecting new or modified data 4. Changes based on data from preclinical studies 5. Revision (expansion or contraction) of population based on data 6. Claims of superiority to another product 7. Change in the labeled storage conditions, unless exempted by regulation or guidance C.