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Master Manufacturing Formula for Chewable Vitamin C Tablets

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A master manufacturing formula for making large scale batches of chewable Vitamin C tablets for commercial production. The master manufacturing formula is contained within the master production …

A master manufacturing formula for making large scale batches of chewable Vitamin C tablets for commercial production. The master manufacturing formula is contained within the master production record produced through InstantGMP MES, a manufacturing execution system with electronic batch records designed for producing products regulated by the FDA. This formula was provided by the formulation development experts at PharmaDirections.com.

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  • The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop.
  • This presentation is just one of many articles and videos available on cGMP compliance for Dietary Supplements. You can find the rest at the Resource Center at www.InstantGMP.com.

Transcript

  • 1. Master Manufacturing FormulaforVitamin C TabletsProvided by theManufacturing Experts atInstantGMP™
  • 2. Electronic Batch Records for cGMP ManufacturingInstantGMP-Lite EBR• Electronic Batch Record Software formanufacturing products regulated by FDA• Master records and batch records on a web-based platform• Quality checks and good manufacturingpractices built in• Makes manufacturing cGMP products easy!
  • 3. Electronic Batch Records for cGMP ManufacturingChewable Vitamin C Tablets• Master manufacturing formula for 250 mgchewable tablets• Tablet recipe based on a product produced forthe US market• Manufacturing instructions provide step wiseprocesses for weighing, blending, compressionand coating• InstantGMP-Lite EBR can be used to make thisproduct
  • 4. Electronic Batch Records for cGMP ManufacturingCover Page With Complete ProductInformation
  • 5. Electronic Batch Records for cGMP ManufacturingBill of Materials With BatchQuantities for Each Ingredient
  • 6. Electronic Batch Records for cGMP ManufacturingEquipment List
  • 7. Electronic Batch Records for cGMP ManufacturingWeighing Steps - Amounts and LotNumbers of Raw Materials
  • 8. Electronic Batch Records for cGMP ManufacturingPre Blending Steps - Includes Targetand Ranges for Mixing Times
  • 9. Electronic Batch Records for cGMP ManufacturingFinal Blending Steps - Includes Targetand Ranges for Mixing Times
  • 10. Electronic Batch Records for cGMP ManufacturingCompression Steps
  • 11. Electronic Batch Records for cGMP ManufacturingInstantGMP-Lite EBR• Overcomes many of the challenges of thetraditional master record and batch recordprocesses of the past• Instantly organize all of your cGMP compliantbatch records anytime in the cloud• Now you and your team can use the “cloud” as aconvenient place to organize and use batchrecords that are acceptable to the FDA
  • 12. InstantGMP™Find more master manufacturingformulas for dietary supplementsin the Resource Center atwww.instantgmp.com