tis

V. FINISHED PRODUCT A. Compounding A working formula card and procedure should be prepared for each batch size. To attempt expansion or reduction of a batch size of a disperse system product by manual calculations at the time of production cannot be considered good practice. Quality assurance must review and check the working formula card and procedures for each production batch before, during, and after production operation for

• Signature and dating when issued by a responsible production person • Proper identification by name and dosage form, item number, lot number, ef-

fective date of document, reference to a superseded version (if any), amount, lot, code number, and release date of each of raw material used

• Calculations of both active and inactive materials, especially if there were any corrections for 100% potencies for actives used

• Reassay dates of components used • Starting and finishing times of each operation • Equipment to be used, record of its cleanliness, and specifications of its setup • Initialing of each step by two of the operators involved • Proper labeling of release components and equipment indicating product name,

strength, size, lot number, and item number

Only released and properly labeled raw materials are allowed in the manufacturing area. Quality assurance should check and verify that the temperature, humidity, microbial monitoring, airborne particulates, and pressure differential in the manufacturing area are within the specified limits. Tables 11-15 show protocols for quality assurance testing for air velocity measurement, high efficiency particulate air (HEPA) filter leak testing, temperature and humidity control tests, pressure differential measurement, and particle count tests, respectively.