How accurate are fill counts for solid oral dosage forms
How Accurate are FillCounts for Solid Oral Dosage Forms?
It Can Be DoneIn the past 25 year companies have achieved 100%efficiencyMust maintain equipmentCompanies seek to achieve a 100% all the timeVariance is typically always present
It Happens All the TimeNot abnormal for variance in fill countsAlso referred to as process capabilityTroy Fugate, vice president, Compliance Insight, Inc.recommends using process-based statistical sampling
Troy FugateHe says that companies ought to focus on Control Understanding Qualification of manufacturing equipment
Simple Not EnoughSetting a stringent fill-count target is not enoughLow fill control targets are required to be inaccordance with both Current Good Manufacturing Practices (cGMPs) US Food and Drug Administration (FDA).
No Specific TargetcGMP does not have specific targetsFDA has not published any related documentsFugate draws the following ideas by reviewing theCode of Federal Regulations: Design equipment to maximize efficiency for its core purpose High performance equipment requires regular calibration and maintenance
Crystal ClearMessage is clear if pharmaceutical manufacturers areserious about reducing variance in fill-counts1. Choose good equipment2. Set clear operational and maintenance policies
Additional FactorsMechanical equipment produces variable resultsThe count can very if: Its a capsule or tablet dosage form being packaged If equipment maintenance is good or poor quality Operational set upThese factors can be controlled
Out of Our Control“Not all factors can be controlled,” says FugateExample Static charge DustThose are essentially impossible to control even withthe best equipment
EthicsPharmaceutical companies adhere to ethicalstandardsEncompass both selection of superior equipment anda commitment to maintenance excellence.
Important ProcessesImportant maintenances processes include: Calibrate and maintain equipment proactively Use process studies or engineering to evaluate equipment quality Refuse equipment that doesn’t meet industry standards Review results regularly to make sure they meet your goals
High StandardsDon’t accept any variance from the target fillobjectiveSome variance will occurAim for 100%Set stringent acceptable tolerance levels to ensuregood results
Compliance ExpertsCompliance Insight, Inc.Your Hands-On Quality and Regulatory SpecialistsOur services include GMP consulting, audit preparation, FDAmock inspections, FDA response assistance, vendor/contractaudits, GMP training and accreditation, new constructioncompliance, regulatory consulting, investigations, biosafety andviral testing consulting; clinical trial audits and more.For more information visit http://compliance-insight1.com/