What are the Best Methods for Maximum Accuracy in Fill Counts for Solid Oral Dosage Forms?

The US Food and Drug Administration (FDA) has not specifically issued any guidelines for accuracy of fill counts for solid oral dosage forms. Troy Fugate, vice president, Compliance nsight, nc. reports that pharmaceutical manufacturers can adopt the follo!ing methods to ensure that ma"imum accuracy is maintained in fill counts for solid oral dosage forms. #elevant sections in the Code of Federal #egulations suggest$ %anufacturers should al!ays use e&uipment !ith the optimum design and one that guarantees the most efficient output as re&uired and intended %anufacturers should ensure that all e&uipment used is cali'rated properly, and is maintained for optimum performance. #egular inspection of e&uipment is mandatory

These general interpretations of the Code of Federal #egulations clearly mean that manufacturers must al!ays choose the 'est and high(&uality e&uipment. Fugate points out that manufacturers must not compromise on the &uality of the e&uipment used and maintenance and operation of the pac)aging e&uipment should 'e very efficient. t is not that strict monitoring !ould al!ays ensure *++ percent fill(count targets are met 'ecause mechanical e&uipment is 'ound to sho! some variation in results. Target variations also depend upon the type of dosage form 'eing pac)aged (e.g. , ta'let, capsule), and the operating set(up. -ut these factors can 'e controlled !hile factors li)e product varia'les (e.g. ( dust, static charge) are impossi'le to control. .ence, stricter monitoring of factors that can 'e controlled !ould ensure ma"imum accuracy in fill counts for oral dosage forms. Apart from using the 'est e&uipment availa'le, proper and regular maintenance should include$ #egular evaluation of the e&uipment capa'ility through monitoring of the processes and engineering /nsuring that all preventive maintenance and cali'ration programs are conducted /&uipment must meet industry standards !ithout compromise #egular processing should 'e monitored strictly

%anufacturers should not 'egin 'y targeting less than *++ percent accuracy !ith the preconceived notion that some variations !ould occur, according to Fugate. The target should 'e ma"imum accuracy. Thereafter, strict controls should 'e maintained to restrict variance to the minimum from the *++ percent fill(count targets in oral dosage forms.

The variance from fill(count target is also )no!n as process capa'ility range. Statistical sampling 'ased upon processing results can 'e used to set an accepta'le and practically achieva'le fill(count target. A strict fill(count target !ould not necessarily ensure 'etter results, 'ut an optimum target !ith strict monitoring of processes and e&uipment !ould ensure minimum variance from the fill(control targets. For more information visit http$00compliance(insight*.com0