Regulatory library

21 CFR Part 211

Part 211 is the CGMP rule for finished pharmaceuticals. For equipment it asks for a design and location that suit the intended use, product-contact materials that do not alter the product, written cleaning and maintenance, calibration of instruments, and controls on automated equipment and its records.

ValDoc's library holds 52 provisions of 21 CFR Part 211. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, depending on their intended use. This page is guidance in our words. The regulation's own text governs.

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Equipment it reaches

Baseline requirements that cite it

  • The site shall control operation, cleaning, maintenance, calibration, training, equipment identification and use/maintenance histories appropriate to intended use.
  • The equipment shall perform the approved intended use over the specified capacity and operating envelope, with installation access for cleaning, inspection and maintenance.
  • The cabinet shall accommodate the specified operations, working envelope and approved installation location while supporting cleaning and maintenance.
  • and 78 more

Provisions in ValDoc's library

  1. 21 CFR 211.22(c)-(d)

    Unchanged since

    Responsibilities of quality control unit

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  2. 21 CFR 211.25(a)

    Unchanged since

    Personnel qualifications

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  3. 21 CFR 211.42(a)-(c)

    Unchanged since

    Design and construction features

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  4. 21 CFR 211.42(c)(10)(i)-(vi)

    Unchanged since

    Design and construction features

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  5. 21 CFR 211.46(a)-(d)

    Unchanged since

    Ventilation, air filtration, air heating and cooling

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  6. 21 CFR 211.48(a)-(b)

    Unchanged since

    Plumbing

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  7. 21 CFR 211.63

    Unchanged since

    Equipment design, size, and location

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  8. 21 CFR 211.65(a)-(b)

    Unchanged since

    Equipment construction

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  9. 21 CFR 211.67(a)-(c)

    Unchanged since

    Equipment cleaning and maintenance

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  10. 21 CFR 211.68(a)

    Unchanged since

    Automatic, mechanical, and electronic equipment

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  11. 21 CFR 211.68(b)

    Unchanged since

    Automatic, mechanical, and electronic equipment

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  12. 21 CFR 211.72

    Unchanged since

    Filters

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  13. 21 CFR 211.94(a)-(d)

    Effective

    Drug product containers and closures

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  14. 21 CFR 211.100(a)-(b)

    Unchanged since

    Written procedures; deviations

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  15. 21 CFR 211.101(b)-(d); 211.68(c)

    Unchanged since

    Automatic, mechanical, and electronic equipment; Charge-in of components

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  16. 21 CFR 211.105(a)-(b)

    Unchanged since

    Equipment identification

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  17. 21 CFR 211.110(a)-(c)

    Unchanged since

    Sampling and testing of in-process materials and drug products

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  18. 21 CFR 211.111

    Unchanged since

    Time limitations on production

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  19. 21 CFR 211.113(a)-(b)

    Unchanged since

    Control of microbiological contamination

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  20. 21 CFR 211.130(a)-(e)

    Unchanged since

    Packaging and labeling operations

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  21. 21 CFR 211.142(a)-(b)

    Unchanged since

    Warehousing procedures

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  22. 21 CFR 211.160(a); 211.160(b)(4)

    Unchanged since

    General requirements

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  23. 21 CFR 211.165(e); 211.194(a)(2)

    Unchanged since

    Testing and release for distribution; Laboratory records

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  24. 21 CFR 211.166(a)(1)-(5); 211.166(b)

    Unchanged since

    Stability testing

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  25. 21 CFR 211.167(a)

    Unchanged since

    Special testing requirements

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  26. 21 CFR 211.180(a)-(e)

    Unchanged since

    General requirements

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  27. 21 CFR 211.182

    Unchanged since

    Equipment cleaning and use log

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  28. 21 CFR 211.186(b)(9); 211.188(b)(2),(4),(8),(11)

    Unchanged since

    Master production and control records; Batch production and control records

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  29. 21 CFR 211.192

    Unchanged since

    Production record review

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  30. 21 CFR 211.194(a)(1)-(8); 211.194(d)

    Unchanged since

    Laboratory records

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  31. 21 CFR 211.150(a)–(b)

    Unchanged since

    Distribution procedures

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  32. 21 CFR 211.122(a)–(h)

    Unchanged since

    Materials examination and usage criteria

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  33. 21 CFR 211.125(a)–(f)

    Effective

    Labeling issuance

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  34. 21 CFR 211.67(b)(1)

    Unchanged since

    Equipment cleaning and maintenance

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  35. 21 CFR 211.67(b)(2)

    Unchanged since

    Equipment cleaning and maintenance

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  36. 21 CFR 211.67(b)(3)

    Unchanged since

    Equipment cleaning and maintenance

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  37. 21 CFR 211.67(b)(4)

    Unchanged since

    Equipment cleaning and maintenance

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  38. 21 CFR 211.67(b)(5)

    Unchanged since

    Equipment cleaning and maintenance

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  39. 21 CFR 211.67(b)(6)

    Unchanged since

    Equipment cleaning and maintenance

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  40. 21 CFR 211.80; 211.82; 211.86-211.89

    Unchanged since

    General requirements; Receipt and storage of untested components, drug product containers, and closures; Use of approved components, drug product containers, and closures; Retesting of approved components, drug product containers, and closures; Rejected components, drug product containers, and closures

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  41. 21 CFR 211.84(a)-(e)

    Unchanged since

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

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  42. 21 CFR 211.103; 211.68(c)

    Unchanged since

    Automatic, mechanical, and electronic equipment; Calculation of yield

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  43. 21 CFR 211.115(a)-(b)

    Unchanged since

    Reprocessing

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  44. 21 CFR 211.132(a)-(c)

    Effective

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

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  45. 21 CFR 211.137(a)-(e)

    Unchanged since

    Expiration dating

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  46. 21 CFR 211.170(a)-(b)

    Effective

    Reserve samples

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  47. 21 CFR 211.184(a)-(e)

    Unchanged since

    Component, drug product container, closure, and labeling records

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  48. 21 CFR 211.196

    Effective

    Distribution records

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  49. 21 CFR 211.198(a)-(b)

    Unchanged since

    Complaint files

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  50. 21 CFR 211.204

    Unchanged since

    Returned drug products

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  51. 21 CFR 211.208

    Unchanged since

    Drug product salvaging

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  52. 21 CFR 211.42(d); 211.46(d); 211.176; FDA CGMP Buildings/Facilities Q&A

    Unchanged since

    Design and construction features; Ventilation, air filtration, air heating and cooling; Penicillin contamination

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