Current Good Manufacturing Practice (cGMP)

A complete library for all of your current good manufacturing practice training needs.

The Current Good Manufacturing Practice (cGMP) is a regulatory prescription for generating drug products that are safe for humans and animals. In the United States, the Food and Drug Administration (FDA) requires pharmaceutical manufacturers and companies that conduct Phase III clinical trials to comply with cGMP regulations.

OSI’s library makes compliance easy for companies in need of cGMP introductory and refresher training with 21 Pharma cGMP courses. Our courses are delivered via a state-of-the-art learning management system that allows you to customize curricula, adjust testing parameters, and even customize courses with site-specific content and photos.

Current Good Manufacturing Practice (cGMP) Course Descriptions

251 Pharma cGMP: Regulations

Pharma cGMP: Regulations defines current good manufacturing practices for the pharmaceutical manufacturing industry. This course contains an overview of 21 CFR Part 211 cGMP for Finished Pharmaceuticals, including the quality control requirements (personnel, facilities, labeling, and documentation) as they apply to manufacturing, packaging, and storing finished pharmaceuticals. (45 min)

260 Introduction to Pharma Current Good Manufacturing Practice (cGMP)

Introduction to Pharma Current Good Manufacturing Practice (cGMP) examines the basic cGMP regulations as regulated by the Food and Drug Administration (FDA) as well as other applicable industry and international standards. (30 min)

261 Pharma cGMP: Personnel

Pharma cGMP: Personnel examines the cGMP roles, responsibilities, qualifications, and requirements of personnel involved in pharmaceutical manufacturing. (20 min)

262 Pharma cGMP: Validation

Pharma cGMP: Validation defines validation and other terms used in the validation process. This course reviews the regulations and discusses FDA guidelines, giving a more detailed review of what is recommended at each of the three stages of validation (process design, process qualification, and continued process verification). (25 min)

263 Pharma cGMP: Documentation

Pharma cGMP: Documentation discusses how to create and maintain cGMP-compliant records. This course emphasizes the importance of good documentation, and explains the four-tiered document system recommended for cGMP facilities, including a review of the documents and their contents. (30 min)

264 Pharma cGMP: Standard Operating Procedures

Pharma cGMP: Standard Operating Procedures discusses the importance of having, understanding, and following standard operating procedures (SOPs). This course reviews the content of an SOP, discusses time-tested tips for effective writing of SOPs, gives an overview of the SOPs required by cGMP regulations, and explains the steps in an SOP management process. (20 min)

265 Pharma cGMP: Buildings, Facilities, and Equipment

Pharma cGMP: Buildings, Facilities, and Equipment examines current Good Manufacturing Practice for buildings, facilities, and equipment involved in the manufacture of pharmaceutical products, including design and construction considerations and equipment selection and maintenance. (35 min)

266 Pharma cGMP: Controlling Materials

Pharma cGMP: Controlling Materials examines the different requirements that control materials used in pharmaceutical manufacturing, including storage, containers, packaging and labeling, sampling, rejection and acceptance, and recalls. (35 min)

267 Pharma cGMP: Sanitation and Hygiene

Pharma cGMP: Sanitation and Hygiene explores current good manufacturing practices for sanitation and hygiene in pharmaceutical manufacturing as it applies to personnel, facilities, equipment, materials, and containers. Additional topics are sanitation in production operations and cross-contamination prevention. (20 min)

268 Pharma cGMP: Sterile Pharmaceutical Production

Pharma cGMP: Sterile Pharmaceutical Production examines requirements for sterile product manufacturing, including air classification, facilities and equipment, environmental monitoring, and production personnel. Types of sterilization methods are also discussed. (40 min)

269 Pharma cGMP: Quality Unit

Pharma cGMP: Quality Unit explains the quality system approach to cGMP that is encouraged by the FDA. This course defines terms, explains concepts, and discusses best practices while also indicating the duties the FDA regulations require of the Quality Unit. (30 min)

270 Pharma cGMP: Complaints and Recalls

Pharma cGMP: Complaints and Recalls examines the complaint and recall process involving pharmaceutical products in distribution by looking at the investigation that takes place when a complaint is filed and the reasons for a recall. (20 min)

271 Pharma cGMP: Inspections and Audits

Pharma cGMP: Inspections and Audits examines self-inspections conducted by drug manufacturing facilities and external audits conducted by the FDA. Topics include the purpose, scope, and frequency of formal self-inspections, as well as quality unit audits, frequency and triggers for external FDA audits, and the FDA’s six-system inspection model. (20 min)

272 Pharma cGMP: Training

Pharma cGMP: Training addresses job competencies and the need for training in the pharmaceutical manufacturing industry. Topics include employee requirements, training triggers, technical training and evaluation, training reports, and specific training. (25 min)

280 Introduction to Food Current Good Manufacturing Practice ( Food cGMP)

Introduction to Food Current Good Manufacturing Practice (Food cGMP) discusses cGMP regulations, specifically 21 CFR 117 and its provisions; regulatory authorities, the Food Codes, and other programs and standards of safe food manufacturing, including HACCP and HARPC (food plan). (25 min)

281 Food cGMP: Hazards to Food Safety

Food cGMP: Hazards to Food Safety reviews the major hazards to food safety that the Food cGMP protects against. Topics include natural toxins, molds, microorganisms, pests, allergens, chemicals, and physical contaminants. It also discusses the food safety plan and preventive controls put in place to prevent contamination and allergen cross-contact. (55 min)

282 Food cGMP: Hygiene and Sanitary Operations

Food cGMP: Hygiene and Sanitary Operations examines the provisions of 21 CFR 117 Subpart B Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food with regard to personnel hygiene, sanitary operations, and pest control in food manufacturing plants. (25 min)

283 Food cGMP: Building, Facilities, and Equipment

Food cGMP: Buildings, Facilities, and Equipment examines the regulatory requirements for the design, construction, and maintenance of a food manufacturing plant and its grounds. This course also examines equipment and utensils used in the plant as well as the plant’s sanitary facilities and controls. (30 min)

284 Food cGMP: Processes and Controls

Food cGMP: Processes and Controls reviews the cGMP requirements for raw materials, manufacturing operations, warehousing, and distribution. This course also describes processes and controls for raw materials inspection and segregation, including how to avoid cross-contamination, and outlines good manufacturing operations, such as using sanitation standard operating procedures, preventive maintenance, and monitoring methods. It also describes the role of a qualified individual in charge of food manufacturing operations. (25 min)

285 Food cGMP: Recalls and Traceability

Food cGMP: Recalls and Traceability examines recalls and traceability in the food manufacturing industry. This course describes the role of the FDA regarding recalls, recall classifications, the elements of a recall plan, and plan evaluation. The course also discusses traceability, including its purpose, definition, methods, and applicable technology. (25 min)