21 C.F.R. PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart A--GENERAL PROVISIONS
Subpart B--ORGANIZATION AND PERSONNEL
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| Responsibilities of quality control unit.
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| Personnel qualifications.
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| Personnel responsibilities.
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Subpart C--BUILDINGS AND FACILITIES
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| Design and construction features.
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| Ventilation, air filtration, air heating and cooling.
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| Washing and toilet facilities.
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Subpart D--EQUIPMENT
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| Equipment design, size, and location.
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| Equipment cleaning and maintenance.
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| Automatic, mechanical, and electronic equipment.
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Subpart E--CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES
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| Receipt and storage of untested components, drug product containers, and closures.
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| Testing and approval or rejection of components, drug product containers, and closures.
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| Use of approved components, drug product containers, and closures.
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| Retesting of approved components, drug product containers, and closures.
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| Rejected components, drug product containers, and closures.
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| Drug product containers and closures.
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Subpart F--PRODUCTION AND PROCESS CONTROLS
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| Written procedures; deviations.
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| Equipment identification.
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| Sampling and testing of in-process materials and drug products.
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| Time limitations on production.
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| Control of microbiological contamination.
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Subpart G--PACKAGING AND LABELING CONTROL
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| Materials examination and usage criteria.
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| Packaging and labeling operations.
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| Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
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Subpart H--HOLDING AND DISTRIBUTION
Subpart I--LABORATORY CONTROLS
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| Testing and release for distribution.
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| Special testing requirements.
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| Penicillin contamination.
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Subpart J--RECORDS AND REPORTS
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| Equipment cleaning and use log.
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| Component, drug product container, closure, and labeling records.
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| Master production and control records.
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| Batch production and control records.
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| Production record review.
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Subpart K--RETURNED AND SALVAGED DRUG PRODUCTS
