Can 100% Accuracy be maintained in Fill Counts for Solid Oral Dosage Forms?

A general survey of how various pharmaceutical firms have been using different types of packaging equipment over the past 25 years shows that 100 percent fill counts for solid oral dosage forms were achieved during normal operations with equipment that was properly maintained. All companies target fill count according to the label claim but variations are always present depending upon equipment capability. The variance in fill count also called process capability range recurs. !Accurate fill limits should be based upon the control" understanding" and qualification of applicable equipment"# says Troy $ugate" vice president" %ompliance &nsight" &nc. !'rocess(based statistical sampling can be used to establish an acceptable fill limit that can be practically maintained. ! A stricter fill(count target does not mean that process controls would automatically become more efficient. A la) fill(control target would not be in accordance with the %urrent *ood +anufacturing 'ractices ,c*+'s- for pharmaceuticals as stipulated by the ./ $ood and 0rug Administration ,$0A-. Though" the $0A has not issued any specific documents regarding fill(control targets because c*+' rules are not that specific. $ugate points out that we could infer the following from the applicable sections in the %ode of $ederal 1egulations2 3quipment should be of proper design so that it can be used most efficiently for the purpose it is intended for 3quipment should be calibrated" and maintained for optimum performance

These are general requirements but they imply that pharmaceutical manufacturers should automatically choose high(quality equipment that offers the least variance from fill(control targets. The packaging equipment must be maintained and operated in the most efficient manner. +echanical equipment would show some variation in results. 4ut" the variations would also depend upon the kind of dosage form being packaged ,e.g. tablet" capsule-" how well the equipment is maintained" and the operating set(up. These factors can be controlled to ensure minimal variation from fill(control targets. !5owever" some factors like product variables ,e.g. ( dust" static charge- are impossible to control. /o" the most sophisticated equipment and vision systems cannot guarantee 100 percent accuracy in fill targets"# says $ugate. All pharmaceutical companies are ethically bound to use the best equipment and ensure proper maintenance. 6ey maintenance processes should include2 'reventive maintenance and calibration programs 3quipment capability evaluation through process studies or engineering

3nsuring the equipment meets industry standards +onitoring regular processes and ensuring that fill(count targets are met on a regular basis

7o allowance should be made for any variance from the target fill at the outset though" it is understood" that some variance would occur. The intention should be to maintain 100 per cent fill(control targets to allow minimal variation. The manufacturers should also set a strict tolerance for e)tent of variation that is acceptable from the fill(count target. $or more information visit http288compliance(insight1.com8