GMP, Compliance, Regulatory

Pharmaceutical GMP - Basics

Overview of Pharmaceutical Manufacturing

Lesson Code: PGB-900. Introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant.

GMP for Finished Dose

Lesson Code: PGB-1101. What GMP is, why it is important for safe guarding the end user, and the laws that govern it.

Regulation of the Pharmaceutical Industry

Lesson Code: PGB-902. Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.

Finished Dose Contamination Prevention

Lesson Code: PGB-1203. This e-Lesson is aimed at personnel who require an overview of how finished dose products can be contaminated during production and how to minimize the risk of contamination through the use of PPE and good hygiene habits.

Dress Codes for Finished Dose Manufacture

Lesson Code: PGB-1204. This e-Lesson is aimed at finished dose manufacturing personnel who require an overview of dress codes, why they are needed, and how they are used in different areas of a finished dose facility.

GMP Goals

Lesson Code: PGB-1105. Describes the GMP responsibilities of employers and employees and the importance of procedures and records.

Overview of GxP

Lesson Code: GXP-1200. This e-Lesson is aimed at personnel who require an overview of the background, purpose, and implementation of GxP regulations (GLP, GCP, GMP) that aim to provide assurance of the safety, efficacy, and quality of pharmaceutical products. It also details the consequences of non-compliance with these regulations

Pharmaceutical GMP - Intermediate

GMP - SOPs in Finished Dose Manufacturing

Lesson Code: PGI-1100. The e-Lesson is aimed at personnel in finished dose manufacturing who use SOPs to ensure that operations are consistently performed correctly and in accordance with relevant GMP regulations.

GMP – Records in Finished Dose Manufacturing

Lesson Code: PGI-1101. This e-Lesson is aimed at personnel who work in the pharmaceutical and biopharmaceutical industries and maintain records for finished dose manufacturing in accordance with GMP Regulations.

Personnel and Training

Lesson Code: PGI-1110. Describes GMP requirements concerning personnel, training, clothing, hygiene and health.

Warehousing

Lesson Code: PGI-1220. This e-Lesson is aimed at personnel who require an overview of warehousing principles and practices in pharmaceutical and biologics facilities.

Cleaning of Equipment

Lesson Code: PGI-1230. Different equipment cleaning methods used in the Pharmaceutical and Biologics Industry.

Sampling

Lesson Code: PGI-1240. This e-Lesson is aimed at personnel who perform sampling tasks on raw materials, manufactured samples, or final products in pharmaceutical manufacturing facilities.

Buildings and Facilities

Lesson Code: PGI-1290. This e-Lesson is aimed at personnel who require an overview of GMP design requirements for a manufacturing facility, including product flow, environmental controls, water supply, cleaning and sanitation, and maintenance.

API Manufacturing GMP - Basics

GMP for APIs

Lesson Code: BGB-1101. This e-Lesson is aimed at personnel working in GMP-regulated API manufacturing environments

API Contamination Prevention

Lesson Code: BGB-1203. How API products can be contaminated during production and how to minimize contamination through the use of PPE and good hygiene habits.

Dress Codes for APIs

Lesson Code: BGB-1204 This e-Lesson is aimed at personnel in API manufacturing who require an overview of dress codes, why they are so important in the API industry, and the different types of PPE typically required for different tasks.

API Manufacturing GMP - Intermediate

GMP - SOPs for APIs

Lesson Code: BGI-1200. This e-Lesson is aimed at personnel in API manufacturing who use SOPs to ensure that operations are consistently performed correctly and in accordance with relevant GMP regulations.

GMP - Records for APIs

Lesson Code: BGI-1101. This e-Lesson is aimed at personnel who require an overview of records in API manufacturing, why these records are essential, how and where they are used, the type of information they typically contain, and the rules for how they should be completed.

Regulatory GMP for Management

Executive Responsibility in Pharmaceutical Manufacturing

Lesson Code: RGM-1200. Overview of the regulatory responsibilities of executive management in the pharmaceutical manufacturing industry. This e-Lesson explains FDA and legal requirements and the corporate and personal consequences of non-compliance.