Pharmaceutical Manufacturing Process

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Questions and Answers

What is the term used to describe the quantity of drug product/device that is homogeneous in character and quality produced during a given cycle of manufacturing?

Batch (correct)

Actual Yield

Lot Number

Component

What is the primary purpose of a Batch Number?

To classify the component of the batch

To trace the complete history of the batch (correct)

To identify the manufacturing order

To determine the actual yield of the batch

What is the term used to describe the material intended to be used for the manufacture of a product?

Component (correct)

Bulk Product

Active Ingredient

Pharmaceutical Excipient

What is the term used to describe the quality that is actually produced at any phase of production of a particular drug?

Actual Yield Signup and view all the answers

What is the purpose of granulation in the pharmaceutical manufacturing process?

To reduce the particle size of the active ingredient Signup and view all the answers

What is the term used to describe the processed material that has to undergo another process including packaging operation to become a finished product?

Bulk Product Signup and view all the answers

What is the primary function of an Active Ingredient in a pharmaceutical product?

To provide pharmacological activity or other effects Signup and view all the answers

What is the term used to describe the process of industrial-scale synthesis of pharmaceutical drugs?

Pharmaceutical Manufacturing Signup and view all the answers

What is the stage in the production cycle that involves weighing of raw materials to finished product?

Processing Signup and view all the answers

What is the term used to describe the act of holding off a material for use, or a product for packaging or distribution?

Quarantine Signup and view all the answers

What is the term used to describe the substances whether active or excipients that are employed in the processing of a finished product?

Raw Material Signup and view all the answers

What is the status of materials or products which are not permitted to be used for processing, packaging or distribution?

Rejected Signup and view all the answers

What is the term used to describe the sample representing the lot, the batch, or the total amount of materials based on a sampling plan?

Representative Sample Signup and view all the answers

What is the term used to describe the finished product which is already in distribution and sent back to the manufacturer or distributor due to a complaint, damage, expiration, validity, or other reasons?

Returned Product Signup and view all the answers

What is the term used to describe the raw materials used in the production?

Starting Materials Signup and view all the answers

What is the term used to describe the quantity that is expected or planned to be obtained at any phase of production based on the quantity of components?

Theoretical Yield Signup and view all the answers

What is the primary goal of pharmaceutical companies?

To be the first to find cures for specific diseases Signup and view all the answers

What is a characteristic of the pharmaceutical industry in the modern era?

It is a large and complex enterprise Signup and view all the answers

What is the main reason for outsourcing in the pharmaceutical industry?

To carry out parts of the drug development process Signup and view all the answers

What is the driving force behind the pharmaceutical industry?

Competition and profits Signup and view all the answers

What is the primary location of the world's largest pharmaceutical companies?

In North America, Europe, and Japan Signup and view all the answers

What is the goal of many countries in the pharmaceutical industry?

To develop the infrastructure necessary for drug companies Signup and view all the answers

What is the primary function of the pharmaceutical industry?

To conduct research, manufacture, and market pharmaceutical and biological products Signup and view all the answers

What is the result of the pharmaceutical industry's drive to be the first to find cures for specific diseases?

A change and evolution of the industry over time Signup and view all the answers

Study Notes

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

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Description

Learn about the industrial-scale synthesis of pharmaceutical drugs, unit operations, and terms used in manufacturing pharmacy.