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 Insight, Inc. reports that pharmaceutical manufacturers can adopt the following methods to ensure that maximum accuracy is maintained in fill counts for solid oral dosage forms.
Relevant sections in the Code of Federal Regulations suggest:
· Manufacturers should always use equipment with the optimum design and one that guarantees the most efficient output as required and intended
· Manufacturers should ensure that all equipment used is calibrated properly, and is maintained for optimum performance. Regular inspection of equipment is mandatory
These general interpretations of the Code of Federal Regulations clearly mean that manufacturers must always choose the best and high-quality equipment. Fugate points out that manufacturers must not compromise on the quality of the equipment used and maintenance and operation of the packaging equipment should be very efficient. It is not that strict monitoring would always ensure 100 percent fill-count targets are met because mechanical equipment is bound to show some variation in results.
Target variations also depend upon the type of dosage form being packaged (e.g. - tablet, capsule), and the operating set-up. But these factors can be controlled while factors like product variables (e.g. - dust, static charge) are impossible to control. Hence, stricter monitoring of factors that can be controlled would ensure maximum accuracy in fill counts for oral dosage forms.
Apart from using the best equipment available, proper and regular maintenance should include:
· Regular evaluation of the equipment capability through monitoring of the processes and engineering
· Ensuring that all preventive maintenance and calibration programs are conducted
· Equipment must meet industry standards without compromise
· Regular processing should be monitored strictly
Manufacturers should not begin by targeting less than 100 percent accuracy with the preconceived notion that some variations would occur, according to Fugate. The target should be maximum accuracy. Thereafter, strict controls should be maintained to restrict variance to the minimum from the 100 percent fill-count targets in oral dosage forms.
The variance from fill-count target is also known as process capability range. Statistical sampling based upon processing results can be used to set an acceptable and practically achievable fill-count target. A strict fill-count target would not necessarily ensure better results, but an optimum target with strict monitoring of processes and equipment would ensure minimum variance from the fill-control targets.
Relevant sections in the Code of Federal Regulations suggest:
· Manufacturers should always use equipment with the optimum design and one that guarantees the most efficient output as required and intended
· Manufacturers should ensure that all equipment used is calibrated properly, and is maintained for optimum performance. Regular inspection of equipment is mandatory
These general interpretations of the Code of Federal Regulations clearly mean that manufacturers must always choose the best and high-quality equipment. Fugate points out that manufacturers must not compromise on the quality of the equipment used and maintenance and operation of the packaging equipment should be very efficient. It is not that strict monitoring would always ensure 100 percent fill-count targets are met because mechanical equipment is bound to show some variation in results.
Target variations also depend upon the type of dosage form being packaged (e.g. - tablet, capsule), and the operating set-up. But these factors can be controlled while factors like product variables (e.g. - dust, static charge) are impossible to control. Hence, stricter monitoring of factors that can be controlled would ensure maximum accuracy in fill counts for oral dosage forms.
Apart from using the best equipment available, proper and regular maintenance should include:
· Regular evaluation of the equipment capability through monitoring of the processes and engineering
· Ensuring that all preventive maintenance and calibration programs are conducted
· Equipment must meet industry standards without compromise
· Regular processing should be monitored strictly
Manufacturers should not begin by targeting less than 100 percent accuracy with the preconceived notion that some variations would occur, according to Fugate. The target should be maximum accuracy. Thereafter, strict controls should be maintained to restrict variance to the minimum from the 100 percent fill-count targets in oral dosage forms.
The variance from fill-count target is also known as process capability range. Statistical sampling based upon processing results can be used to set an acceptable and practically achievable fill-count target. A strict fill-count target would not necessarily ensure better results, but an optimum target with strict monitoring of processes and equipment would ensure minimum variance from the fill-control targets.
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