Pharmaceutical Industry Overview

Study Notes

Aims of the Pharmaceutical Industry

Manufacture and market safe, effective, and high-quality drug products, biological products, and medical devices
Conduct research in the pharmaceutical field.

Responsibility for Drug Quality Testing

Ministry of Health (Egypt)
National Health Authority (Egypt)
National Organization for Drug Control & Research (Egypt)
Now: Egyptian Drug Authority

Factors Contributing to Good Manufacturing Practices

Building design and construction
Production processes
Equipment used
Personnel involved
Documentation

Definitions

Air Lock: An enclosed space with two or more doors, only one open at a time, to control airflow.
Air Curtain: Present at any door of an air lock to prevent dust accumulation and cross-contamination.
Authorized Person: Responsible for releasing batches and ingredients.
Batch or Lot: A defined quantity of drug product (dosage form) or other material manufactured under the same conditions to ensure consistent quality.
Batch Number: A unique combination of numbers and/or letters identifying a batch for tracing its history.
Batch Record: Documentation containing all details of a batch's manufacture, including materials, quantities, procedures, quality control investigations, acceptance criteria, and production history.
Bulk Product: A product that has undergone all stages of production, excluding packaging and labeling.
Finished Product: A product that has undergone all stages of production, including packaging and labeling.
In-Process Control: Monitoring and adjustment of the process to ensure adherence to specifications.
Calibration: Establishing a relationship between values indicated by an instrument and values obtained from a reference standard.
Clean Area: A controlled environment with reduced particulate and microbial contamination, achieved through construction and usage practices.
Critical Process: A process where variations can impact the quality of the pharmaceutical product (e.g., granulation, drying, mixing).
Validation: Proving that a manufacturing process meets its intended purpose and delivers the expected results.
Cross Contamination: Contamination of starting materials, intermediate products, or finished products with materials from different production lines.
Documentation: All written procedures, instructions, descriptions, specifications, and records involved in the manufacture of a drug product.
Expiration Date: The date on a drug product's label designating when the product is expected to meet specifications. It is the time required for 10% of the material to degrade. If only a month and year are provided, the product is expected to meet specifications through the last day of the month.
Infra Structure of Factory: Provides essential utilities such as superheated steam, electricity, air, gases, deionized water, and sterile water.