Good Manufacturing Practices (GMP)

To best understand the Current Good Manufacturing Practice (CGMP) requirements, it is helpful to review the history and evolution of the regulations. This module covers key cases that helped form current GMPs, then reviews each section from key manufacturing regulations 21 CFR 210 and 211. It also describes the importance of the term “current” in the regulations.

Recommended Use: Required
ID (Language): 20408 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

A quality system is the foundation that allows an organization to adhere to Current Good Manufacturing Practices (CGMPs), which in turn allows it to consistently meet or exceed its customer’s specifications. This module describes the purpose and organization of a quality system in manufacturing, differentiates quality assurances and quality controls, reviews SOPs for key processes, and describes roles and responsibilities for individuals focused on quality.

Recommended Use: Required
ID (Language): 20409 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Personnel are essential to the production of pharmaceuticals; without them the drug product would not be produced.  Staff must be properly trained and qualified. An organization adhering to CGMPs should clearly define, develop, demonstrate, and document all staff competencies working in the CGMP environment.

This module provides an overview of personnel requirements for CGMP. It discusses staff training, job descriptions, and qualifications. It also explores key personnel roles along with hygiene and wellness program considerations.

Recommended Use: Required
ID (Language): 20410 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

A Good Manufacturing Practice (GMP) facility’s design is critical to the overall functioning of the manufacturing process. There are many different components to consider: from flow of staff and equipment, to the water system plumbing, as well as the electrical system and lighting.  Proper environmental monitoring is also critical to continuously verify microbiological and particulate counts. The heating, ventilation, and air conditioning (HVAC) system design must also be considered to ensure adequate air flow and filtration to ensure no cross contamination occurs.

This module reviews the FDA’s GMP requirements related to facility design, HVAC controls, facility cleaning, environmental monitoring, water systems, validation master plans, equipment and instrument calibration and maintenance, and cleaning programs and cleaning validation.

Recommended Use: Required
ID (Language): 20411 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

There are specific regulatory requirements for the validation of software, processes, and analytical methods used in manufacturing. In this module, we will explore the procedures for software validation, process validation, and analytical method validation according to Current Good Manufacturing Practices (CGMPs). This module also reviews key regulations and requirements for validation and pitfalls to avoid.

Recommended Use: Required
ID (Language): 20412 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Batch production records (also known as batch records) provide step-by-step instructions on how to manufacture a product, while also collecting the detailed information for the specific lot being made. A batch is synonymous with the lot produced.  There are many important parameters involved when making a batch following Current Good Manufacturing Practices (CGMPs). Each step is important and must be followed as prescribed.  Sampling instructions, time limits, and other sequences are typical of the detailed instructions captured within a batch record.  Once the batch is complete the quality unit reviews all the documentation to verify the product meets the pre-approved specifications and was manufactured according to the CGMPs.  Many documents and other records support the batch record and are reviewed and approved by the quality unit to release a product.

This module reviews the purposes and key components of batch records, and the associated CGMPs’ documentation requirements. The module concludes with a discussion on good documentation practices and document storage.

Recommended Use: Required
ID (Language): 20413 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

After manufacturing, the regulations require proper packaging, labeling, storage, and distribution of the drug product or substance. Standard operating procedures are necessary to define the operations and quality control parameters essential to maintain a state of control. Clear documentation within the batch record will assure regulatory agencies (such as the FDA) that regulatory requirements were upheld during the manufacturing process.

In this module, we examine the GMP requirements and procedures for packaging, labeling, storage, and distribution processes. The module highlights the required standard operating procedures, reviews typical FDA inspectional observations to avoid, and reviews requirements for stability testing and expiration dating.

Recommended Use: Required
ID (Language): 20414 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

Audits and inspections are a essential elements of the quality system. While being audited or inspected can create anxiety, it also promotes assurance that an organization adhering to current GMP regulations is following the regulations and procedures.

This module describes the purpose of an internal audit program and differentiates internal audits from external audits and inspections. It focuses on the various types of quality audits used in the GMP environment. It also discusses mock inspections and what an inspection preparedness program should include.

Recommended Use: Required
ID (Language): 20415 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix