MCCCD Program Description

Introduction to Good Manufacturing Practices(GMP)-Regulated Manufacturing

Course: ABS171

First Term: 2019 Spring

Lecture 3.0 Credit(s) 3.0 Period(s) 3.0 Load
Subject Type: Occupational
Load Formula: S- Standard

Description: Course is designed to provide individuals with an overview of Good Manufacturing Practices (GMP), their application in a variety of industries and the opportunities for in such fields.

MCCCD Official Course Competencies
1. Compare and contrast Good Manufacturing Practices(GMP)-regulatory policies and overseeing agencies throughout the world. (I) 2. Describe the benefits of GMP regulations and how they have changed with the times. (I) 3. Describe GMP regulations critical to the commercial manufacturing of food products, cosmetics, dietary supplements, medical devices, and drugs and finished pharmaceuticals. (II, III) 4. Compare and contrast the responsibilities of the Quality Control Unit, key personnel and consultants. (IV) 5. Describe elements critical to a sound GMP-training program. (IV) 6. Describe possible consequences of poor hygiene to GMP-manufacturing. (IV) 7. Describe key building and equipment attributes of a GMP-manufacturing facility. (V, VI) 8. Describe controls used to prevent contamination of components, containers and closures. (VII) 9. Provide examples of why control of components is important in GMP-manufacturing. (VII) 10. Explain the differences between policies, procedures and work practices. (VIII) 11. Calculate yield losses throughout a GMP-manufacturing process. (VIII) 12. Describe why time limits are critical in some GMP-regulated processes. (VIII) 13. Define basic packaging and labeling controls. (IX) 14. Provide examples that illustrate why packaging of "over the counter" (OTC) products to be tamper evident is critically important. (IX) 15. Define key warehousing and distribution considerations in GMP-regulated industries. (X) 16. Explain the need for testing at all stages of manufacturing as well as of product stability. (XI) 17. Describe how expiration dating for a new product is established. (XI) 18. Distinguish between a "Master Production and Control Record" and a "Batch Production and Control Record." (XII) 19. Identify some records and reports kept in GMP-regulated environment and describe why this kind of documentation is important in these industries. (XII) 20. Identify workforce opportunities in GMP-regulated manufacturing industries and the training, education and experience critical and/or advantageous for employment and advancement in each. (XIII) 21. Identify the most memorable and meaningful firsthand experiences while touring the facilities of different kinds of GMP-regulated manufacturers. (XIV)
MCCCD Official Course Competencies must be coordinated with the content outline so that each major point in the outline serves one or more competencies. MCCCD faculty retains authority in determining the pedagogical approach, methodology, content sequencing, and assessment metrics for student work. Please see individual course syllabi for additional information, including specific course requirements.

MCCCD Official Course Outline
I. Introduction to Good Manufacturing Practices (GMP) regulations A. Overview of global policies B. History C. Current and anticipated future changes II. Food / cosmetic / dietary supplement GMPs A. Food GMPs 1. International Standardization Organization (ISO) 22000 2. US Federal Drug Administration (FDA) Code of Federal Regulations 21CFR Part 110 3. Hazard Analysis and Critical Control Points (HACCP) B. Cosmetic GMPs 1. ISO 22716 2. US guidance documents C. Dietary supplement GMPs 1. ISO Technical Committee (TC)/217 2. US FDA 21CFR Part 111 3. NSF/American National Standards Institute (NSF/ANSI) Standards III. Medical device/ drugs and finished product GMPs A. Medical device GMPs 1. ISO 13485 2. US FDA 21Code of Federal Regulation (CFR) Part 820 B. Drugs and finished pharmaceuticals GMPs 1. ISO Identification of Medicinal Products (IDMP) 2. US FDA 21CFR Parts 210 and 211 3. EU EudraLex, Volume 4, Chapters 1-9 4. Other regulatory agencies IV. Organization and personnel A. Responsibilities of Quality Control Unit B. Personnel qualifications C. Personnel responsibilities / Key personnel D. Consultants E. Training F. Personnel hygiene V. Buildings and facilities A. Production, storage, quality control and ancillary areas B. Design and construction features C. Lighting D. Ventilation, air filtration, air heating and cooling E. Plumbing F. Sewage and refuse VI. Equipment A. Equipment design, size and location B. Equipment construction, installation and validation C. Equipment cleaning and maintenance D. Automatic, mechanical and electronic equipment E. Filters VII. Control of components, containers and closures A. General requirements B. Receipt and storage of untested materials C. Testing and approval or rejection D. Use once approved E. Retesting F. Rejected items VIII. Production and process controls A. Written procedures B. Deviations from written procedures C. Charge-in of components D. Calculation of yield E. Equipment Identification F. Sampling and testing of "in-process" materials G. Time limits on production H. Control of microbiological contamination I. Reprocessing IX. Packaging and labeling controls A. Materials examination and usage criteria B. Labeling Issuance C. Packaging and labeling operations D. "Tamper evident" packaging E. Drug product inspection F. Expiration dating X. Holding and distribution A. Warehousing B. Distribution XI. Laboratory controls A. General requirements B. Testing and release for distribution C. Stability testing D. Special testing requirements E. Reserve samples F. Laboratory animals G. Penicillin contamination XII. Records and reports A. General requirements B. Equipment cleaning and use logs C. Component, container, closure and labeling records D. Master production and control records E. Batch production and control records F. Production record review G. Laboratory records H. Distribution records I. Complaint files XIII. Careers in GMP-regulated manufacturing A. Manufacturing B. Quality control C. Quality assurance D. Technical services E. Engineering and maintenance F. Information technology G. Finance H. Human resources XIV. Facilities tour options A. Food manufacturer B. Medical device manufacturer C. Pharmaceutical manufacturer D. Other GMP-regulated manufacturer

MCCCD Governing Board Approval Date: December 11, 2018

All information published is subject to change without notice. Every effort has been made to ensure the accuracy of information presented, but based on the dynamic nature of the curricular process, course and program information is subject to change in order to reflect the most current information available.