21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals

Categories: Auditing, Quality Tools, Regulations, Standards

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About Course

Build your knowledge of the FDA’s current good manufacturing practice (cGMP) requirements for finished pharmaceuticals. This self-paced course walks you through 21 CFR Part 211, including personnel, facilities, equipment, production controls, laboratory testing, and records.

Whether you manufacture drug products, oversee quality, or conduct audits, you’ll learn how these requirements support consistent production and product quality. Learn on your schedule and earn a Certificate of Completion after successfully completing the course and passing the final exam.

Course Content

Acknowledgements and Attestation

Acknowledgements and Attestation

Subpart A—General Provisions

Subpart B—Organization and Personnel

Subpart C—Buildings and Facilities

§ 211.42 Design and construction features.
§ 211.44 Lighting.
§ 211.46 Ventilation, air filtration, air heating and cooling.
§ 211.48 Plumbing.
§ 211.50 Sewage and refuse.
§ 211.52 Washing and toilet facilities.
§ 211.56 Sanitation.
§ 211.58 Maintenance.
Subpart C- Quiz

Subpart D—Equipment

Subpart E—Control of Components and Drug Product Containers and Closures

Subpart F—Production and Process Controls

§ 211.100 Written procedures; deviations.
§ 211.101 Charge-in of components.
§ 211.103 Calculation of yield.
§ 211.105 Equipment identification.
§ 211.110 Sampling and testing of in-process materials and drug products.
§ 211.111 Time limitations on production.
§ 211.113 Control of microbiological contamination.
§ 211.115 Reprocessing.
Subpart F- Quiz

Subpart G—Packaging and Labeling Control

Subpart H—Holding and Distribution

Subpart I—Laboratory Controls

Subpart J—Records and Reports

§ 211.180 General requirements.
§ 211.182 Equipment cleaning and use log.
§ 211.184 Component, drug product container, closure, and labeling records.
§ 211.186 Master production and control records.
§ 211.188 Batch production and control records.
§ 211.192 Production record review.
§ 211.194 Laboratory records.
§ 211.196 Distribution records.
§ 211.198 Complaint files.
Subpart J- Quiz

Subpart K—Returned and Salvaged Drug Products

21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

Add this certificate to your resume to demonstrate your skills & increase chances for hiring and promotions.

About Course

Course Content

Acknowledgements and Attestation

Acknowledgements and Attestation

Subpart A—General Provisions

§ 211.1 Scope.

§ 211.3 Definitions.

Subpart A- Quiz

Subpart B—Organization and Personnel

§ 211.22 Responsibilities of quality control unit.

§ 211.25 Personnel qualifications.

§ 211.28 Personnel responsibilities.

§ 211.34 Consultants.

Subpart B- Quiz

Subpart C—Buildings and Facilities

§ 211.42 Design and construction features.

§ 211.44 Lighting.

§ 211.46 Ventilation, air filtration, air heating and cooling.

§ 211.48 Plumbing.

§ 211.50 Sewage and refuse.

§ 211.52 Washing and toilet facilities.

§ 211.56 Sanitation.

§ 211.58 Maintenance.

Subpart C- Quiz

Subpart D—Equipment

§ 211.63 Equipment design, size, and location.

§ 211.65 Equipment construction.

§ 211.67 Equipment cleaning and maintenance.

§ 211.68 Automatic, mechanical, and electronic equipment.

§ 211.72 Filters.

Subpart D- Quiz

Subpart E—Control of Components and Drug Product Containers and Closures

§ 211.80 General requirements.

§ 211.82 Receipt and storage of untested components, drug product containers, and closures.

§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.

§ 211.86 Use of approved components, drug product containers, and closures.

§ 211.87 Retesting of approved components, drug product containers, and closures.

§ 211.89 Rejected components, drug product containers, and closures.

Subpart E- Quiz

Subpart F—Production and Process Controls

§ 211.100 Written procedures; deviations.

§ 211.101 Charge-in of components.

§ 211.103 Calculation of yield.

§ 211.105 Equipment identification.

§ 211.110 Sampling and testing of in-process materials and drug products.

§ 211.111 Time limitations on production.

§ 211.113 Control of microbiological contamination.

§ 211.115 Reprocessing.

Subpart F- Quiz

Subpart G—Packaging and Labeling Control

§ 211.122 Materials examination and usage criteria.

§ 211.125 Labeling issuance.

§ 211.130 Packaging and labeling operations.

§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

§ 211.134 Drug product inspection.

§ 211.137 Expiration dating.

Subpart G- Quiz

Subpart H—Holding and Distribution

§ 211.142 Warehousing procedures.

§ 211.150 Distribution procedures.

Subpart H- Quiz

Subpart I—Laboratory Controls

§ 211.160 General requirements.

§ 211.165 Testing and release for distribution.

§ 211.166 Stability testing.

§ 211.167 Special testing requirements.

§ 211.170 Reserve samples.

§ 211.173 Laboratory animals.

§ 211.176 Penicillin contamination.

Subpart I- Quiz

Subpart J—Records and Reports

§ 211.180 General requirements.

§ 211.182 Equipment cleaning and use log.

§ 211.184 Component, drug product container, closure, and labeling records.

§ 211.186 Master production and control records.

§ 211.188 Batch production and control records.

§ 211.192 Production record review.

§ 211.194 Laboratory records.

§ 211.196 Distribution records.

§ 211.198 Complaint files.

21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.