Pharmaceutical Manufacturing Process

Drug Manufacturing Process

• Industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry
• Broken down into series of unit operations, such as milling, granulation, coating, tablet pressing, and others

Key Terms in Manufacturing Pharmacy

• Actual Yield: Quality produced at any phase of production based on initial input
• Active Ingredient or Active: Component intended to furnish pharmacological activity or other effects on diagnosis, cure, mitigation, treatment, or prevention of disease
• Batch: Quantity of drug product/device produced during a given cycle of manufacturing and from a specific manufacturing order
• Batch Number (or Lot Number): Designation of number or letter or combination that identifies the batch and permits tracing of its complete history

Manufacturing Process

• Bulk Product: Processed material that undergoes another process, including packaging operation, to become a finished product
• Component: Material intended to be used for manufacturing a product, whether raw materials or packaging materials
• Excipients: Materials used in manufacturing a product

Current Good Manufacturing Practices (cGMP)

• Pharmaceutical industry conducts research, manufactures, and markets pharmaceutical and biological products and medical devices
• Industry is driven largely by profits and competition, striving to be the first to find cures for specific diseases
• cGMP includes outsourcing, where companies contract with specialty manufacturers or research firms to carry out parts of the drug development process

Quality Control and Assurance

• Processing: Part of the production cycle from weighing of raw materials to finished product
• Production: All operations starting from dispensing materials to processing, packaging, to a finished product
• Quality Control: Control measures designed to ensure finished products consistently conform to established specifications of identity, purity, strength, and quality
• Quarantine: Act of holding off a material for use or a product for packaging or distribution pending a decision on release or rejection
• Raw Material: Substances employed in the processing of a finished product
• Rejected: Status of materials or products not permitted to be used for processing, packaging, or distribution
• Released or Passed: Status of materials or products permitted to be used for processing, packaging, or distribution
• Representative Sample: Sample representing the lot, batch, or total amount of materials based on a sampling plan
• Returned Product: Finished product sent back to the manufacturer or distributor due to a complaint, damage, expiration, or other reasons
• Starting Materials: Raw materials used in the production
• Theoretical Yield: Quantity expected or planned to be obtained at any phase of production based on the quantity of components