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21 CFR Part 211 Subpart I: Laboratory Controls
21 CFR Part 211 Subpart I: Laboratory Controls
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21 CFR § 211.101 Production and Process Controls Charge-in of components.
21 CFR § 211.100 Production and Process Controls Written procedures; deviations.
21 CFR § 211 86 87 89, Approved, Retesting and Rejected
21 CFR § 211.84 Testing and approval or rejection of components, drug product containers & closures
21 CFR § 211.82 Receipt and storage of untested components, drug product containers, and closures.
21 CFR § 211.80 Control of Components and Drug Product Containers and Closures
§ 211.44 Lighting. § 211.50 Sewage and refuse. § 211.52 Washing and toilet facilities. § 211.58 Maintenance.
21 CFR § 211.56 Sanitation.
21 CFR § 211.48 Plumbing.
21 CFR § 211.46 Ventilation, Air filtration, Air heating and Cooling.
21 CFR § 211.42 Design and construction features.
21 CFR § 211.34 Consultants.
21 CFR § 211.25 Personnel Qualifications.
21 CFR § 211.22 Responsibilities of Quality Control Unit
21 CFR § 211.70 Filters.
21 CFR § 211.68 Automatic, mechanical, and electronic equipment.
21 CFR § 211.67 Equipment cleaning and maintenance
21 CFR § 211.65 Equipment construction
21 CFR § 211.63 Equipment design, size, and location
21 CFR Part 211 Subpart K: Returned and Salvaged Drug Products
21 CFR Part 211 Subpart J: Records and Reports
21 CFR Part 211 Subpart H: Holding & Distribution Controls
21 CFR Part 211 Subpart G: Packaging and Labeling Control
21 CFR Part 211 Subpart F: Production and Process Controls
21 CFR Part 211 Subpart E: Control of Components, Drug Product Containers and Closures
21 CFR Part 211 – Subpart D: Equipment
21 CFR Part 211 Subpart C: Building and Facilities
21 CFR Part 211 Subpart B: Organization and Personnel
21 CFR Part 211 Subpart A General Provisions