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发帖数: 25265 | 1 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
§ 211.1 - Scope.
§ 211.3 - Definitions.
Subpart B--Organization and Personnel
§ 211.22 - Responsibilities of quality control unit.
§ 211.25 - Personnel qualifications.
§ 211.28 - Personnel responsibilities.
§ 211.34 - Consultants.
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 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 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.
§ 211.94 - 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 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 H--Holding and Distribution
§ 211.142 - Warehousing procedures.
§ 211.150 - Distribution procedures.
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 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 K--Returned and Salvaged Drug Products
§ 211.204 - Returned drug products.
§ 211.208 - Drug product salvaging. | s**********8
发帖数: 25265 | 2 TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL PART 210 CURRENT GOOD MANUFACTURING PRACTICE
IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
§ 210.1 - Status of current good manufacturing practice regulations.
§ 210.2 - Applicability of current good manufacturing practice regulations.
§ 210.3 - Definitions. |
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