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. ccurate fill limits should be based upon the control,MBT Kaya Schuhe, understanding, and qualification of applicable equipment,Mbt Sandalen Pia,?says Troy Fugate,billige MBT Schuhe, vice president, Compliance Insight,Mbt Moto Stiefel, Inc. rocess-based statistical sampling can be used to establish an acceptable fill limit that can be practically maintained. ?br />
A stricter fill-count target does not mean that process controls would automatically become more efficient. A lax fill-control target would not be in accordance with the Current Good Manufacturing Practices (cGMPs) for pharmaceuticals as stipulated by the US Food and Drug Administration (FDA).
Though,Mbt Schuhe Meli, the FDA has not issued any specific documents regarding fill-control targets because cGMP rules are not that specific. Fugate points out that we could infer the following from the applicable sections in the Code of Federal Regulations:
?Equipment should be of proper design so that it can be used most efficiently for the purpose it is intended for
?Equipment 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.
Mechanical equipment would show some variation in results. But, the variations would also depend upon the kind of dosage form being packaged (e.g. ?tablet, capsule),MBT Sini Schuhe, how well the equipment is maintained, and the operating set-up. These factors can be controlled to ensure minimal variation from fill-control targets. owever, some factors like product variables (e.g. - dust, static charge) are impossible to control. So, the most sophisticated equipment and vision systems cannot guarantee 100 percent accuracy in fill targets,?says Fugate.
All pharmaceutical companies are ethically bound to use the best equipment and ensure proper maintenance.
Key maintenance processes should include:
reventive maintenance and calibration programs
quipment capability evaluation through process studies or engineering
nsuring the equipment meets industry standards
onitoring regular processes and ensuring that fill-count targets are met on a regular basis
No allowance should be made for any variance from the target fill at the outset though, it is understood,Mbt Sandalen Ema, 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 extent of variation that is acceptable from the fill-count target. 相关的主题文章：
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