Drug Regulations is a Not for Profit Organizations which provides free online resources for the Pharmaceutical Professional. This presentation is part E of series of presentations which addresses the current Good Manufacturing Requirements as per the US FDA. This presentation addresses : Control of Components , Drug Product Containers & Closures
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GMP's as per US FDA : Part E
1. This presentation is compiled by “ Drug Regulations”
a non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
11/17/2014 1
2. This presentation is compiled from freely
available resource like the website of FDA.
“Drug Regulations” is a non profit
organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/17/2014 2
Drug Regulations : Online
Resource for Latest Information
3. ◦ This presentation is part E of series of presentations which addresses the current Good
Manufacturing Requirements as per the US FDA.
◦ Part A : Status , Scope & Definitions
◦ Part B : Organization & Personnel
◦ Part C: Buildings & Facilities
◦ Part D : Equipment
◦ Part E : Control of Components , Drug Product Containers & Closures
◦ Part F : Production & Process Controls
◦ Part G : Packaging & Labeling Control
◦ Part H : Holding & Distribution
◦ Part I : Laboratory Controls
◦ Part J : Records & Reports
◦ Part K : Returned & Salvaged Products
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4. 211.80 (a)
Written procedures∗ required for the
◦ Receipt
◦ Identification
◦ Storage
◦ Handling
◦ Sampling
◦ Testing
◦ Approval or rejection
Follow written procedures
∗ for components and drug product containers and closures;
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5. 211.80 (b)
Appropriately Handle & Store components
and drug product containers and closures to
prevent contamination.
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6. 211.80 ( c )
Bagged or boxed components∗
Ensure storage off the floor
Store suitably spaced to permit cleaning and
inspection.
∗ of drug product containers, or closures
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7. 211.82 ( a )
Container or grouping of containers of components, drug
product containers, and closures
◦ Examine each visually for appropriate labeling
Contents
Container damage
Broken seals
Contamination
Complete the above upon receipt and before acceptance
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8. 211.82 ( b )
Components, drug product containers, and
closures
◦ Store under quarantine
◦ Test or examine
◦ Store as per requirements of §211.80.
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9. 211.84 ( a )
Each lot of components, drug product containers, and
closures
Withhold each lot from use until the lot has been
◦ Sampled
◦ Tested or
◦ Examined
◦ Released for use
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10. 211.84 (c )
Collect samples as per following procedures:
◦ (1) Clean the containers to prevent contamination of
component.
◦ (2) Open, sample, and reseal containers to prevent
contamination of their contents
◦ (3) Use sterile equipment and aseptic sampling
techniques when necessary.
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11. 211.84 (c )
Collect samples as per following procedures:
◦ (4) Do not composite a sample if it is necessary to
sample a component from the top, middle, and
bottom of its container
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12. 211.84 (c )
Collect samples as per following procedures:
◦ (5) Identify sample containers to following information :
Name of the material sampled
The lot number
The container from which the sample was taken
The date on which the sample was taken
The name of the person who collected the sample
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13. 211.84 (c )
Collect samples as per following procedures:
◦ (6) Mark containers from which samples have been
taken to show that samples have been removed
from them.
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14. 211.84 (d ) ( 1)
Examine & Test Samples as follows:
◦ Conduct at least one test to verify the identity of
each component of a drug product.
◦ Use specific identity tests if they exist
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15. 211.84 (d ) ( 2)
Test each component for conformity with all
written specifications for
◦ Purity
◦ Strength
◦ Quality
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16. 211.84 (d ) ( 2)
Manufacturer can skip this testing if
◦ A report of analysis is provided by the supplier and
◦ At least one specific identity test is conducted by the
manufacturer and
◦ The manufacturer establishes the reliability of the
supplier's analyses through appropriate validation of the
supplier's test results at appropriate intervals.
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17. 211.84 (d ) (3)
Test containers and closures for conformity with all written
specifications.
This testing can be skipped if
◦ The supplier provides a certificate of testing and
◦ At least a visual identification is conducted by the manufacturer and
◦ The manufacturer establishes the reliability of the supplier's test results
through appropriate validation of the supplier's test results at appropriate
intervals.
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18. 211.84 (d ) ( 4)
Examine components microscopically when
appropriate
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19. 211.84 (d ) (5)
Examine each lot∗ that is liable to contamination
against established specifications for
contamination such as
◦ Filth
◦ Insect infestation
◦ Other extraneous adulterant
∗ of a component, drug product container, or closure
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20. 211.84 (d ) (6)
Subject each lot∗ with potential for
microbiological contamination that is
objectionable in view of its intended use to
microbiological tests before use.
∗of a component, drug product container, or closure
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21. 211.84 (e )
Any lot∗ that meets the appropriate written specifications under
paragraph (d) of this section may be approved and released for use.
◦ Identity
◦ Strength
◦ Quality
◦ Purity
◦ Related tests
Any lot that does not meet such specifications shall be rejected.
∗of components, drug product containers, or closures
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22. 211.86
Rotate stock∗ so that the oldest approved stock
is used first
Deviation from this requirement is permitted if
such deviation is temporary and appropriate.
∗Components, drug product containers, and closures
approved
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23. 211.87
Retesting or Reexamination
◦ Retest or re-examine lots∗ and approve or reject in
accordance with §211.84 as necessary
Identity
Strength
Quality
Purity
∗Components, drug product containers, and closures
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24. 211.87
Retesting or Reexamination
◦ After storage for long periods
◦ After exposure to air, heat or other conditions that
might adversely affect the lot∗
∗Components, drug product containers, and closures
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25. 211.89
Rejected lot ∗
◦ Identify
◦ Control under a quarantine
◦ Prevent their use in manufacturing or processing
operations for which they are unsuitable
∗components, drug product containers, and closures
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26. 211.94 (a)
Drug product containers and closures shall not be
◦ Reactive
◦ Additive
◦ Absorptive
so as to alter the safety, identity, strength, quality, or
purity of the drug beyond the official or established
requirements.
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27. 211.94 ( b)
Container closure systems
◦ Provide adequate protection against external
factors in storage and use that can cause
deterioration or contamination of the drug product.
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28. 211.94 (c)
Drug product containers and closures
◦ Shall be clean
◦ Sterilized∗
◦ Processed to remove pyrogenic properties∗
To assure that they are suitable for their intended use.
Such depyrogenation processes shall be validated
∗ based on the intended use
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29. 211.94 (d)
Provide written procedures∗
◦ Standards or specifications
◦ Methods of testing
◦ Methods of cleaning
◦ Sterilizing
◦ Processing to remove pyrogenic properties
Follow written procedures
∗drug product containers and closures.
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30. This presentation is compiled from freely
available resource like the website of FDA.
“Drug Regulations” is a non profit
organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/17/2014 30
Drug Regulations : Online
Resource for Latest Information