Pharmaceutical Manufacturing (with QA and cGMP) PDF
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E.D. Gloria, RPh
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Summary
This document provides an outline of pharmaceutical manufacturing, including topics such as labeling requirements, formulation development, raw materials, quality assurance, and various types of dosage forms. It also discusses specific examples of tablets, capsules, and their components. The document appears to be a presentation or lecture notes on the topic of pharmaceutical manufacturing.
Full Transcript
Pharmaceutical Manufacturing (with QA and cGMP) Outline Introduction Minimum Labeling Requirement Formulation Development API Selection Excipients Selection Preformulation Studies Lab scale to Manufacturing scale Raw Materials and Packaging Materials Quality Assuranc...
Pharmaceutical Manufacturing (with QA and cGMP) Outline Introduction Minimum Labeling Requirement Formulation Development API Selection Excipients Selection Preformulation Studies Lab scale to Manufacturing scale Raw Materials and Packaging Materials Quality Assurance cGMP Tablets Mixing and Blending Granulation Drying Compression Packaging Manufacturing Process Flow Chart Requisition of Testing of Weighing Blending Granulation Materials Materials Testing of Coating Release for Compression Packaging Finished (optional) Distribution product Paracetamol Tablet Ingredients Ingredient Purpose Acetaminophen Active ingredient Lactose Diluent/Filler Corn starch Diluent/Disintegrant Starch paste (10%) Binder Talc Glidant/Lubricant Magnesium stearate Lubricant Soda Mint Tablet Ingredients Ingredient Purpose Sodium bicarbonate Active ingredient Peppermint oil Flavoring agent Saccharin Sweetening agent Purified talc Glidant/Lubricant Acacia solution (5%) Binder Hard-Gelatin Capsules Blending and Mixing Filling Capsule Sealing Polishing and Sorting Manufacturing Process Flow Chart Preparation Requisition of Testing of Capsule Weighing of the fill Materials Materials Filling material Testing of Polishing and Release for Packaging Finished inspection Distribution product Amoxicillin Capsule Ingredients Ingredients Purpose Amoxicillin Active ingredient Cornstarch Diluent/Disintegrant Magnesium stearate Lubricant Hard Gelatin Capsules Capsule Size Volume (mL) Approximate Weight Capacity 000 1.37 – 1.40 800 – 1600 mg 00 0.95 – 1.00 600 – 1100 mg 0 0.68 – 0.70 400 – 800 mg 1 0.48 – 0.50 300 – 600 mg 2 0.36 – 0.37 200 – 500 mg 3 0.27 – 0.30 200 – 300 mg 4 0.20 – 0.21 150 – 200 mg 5 0.13 -.15 60 – 130 mg
