GMP's as per US FDA : Part E

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

 This presentation is compiled from freely
available resource like the website of FDA.
“Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/17/2014 2
Drug Regulations : Online
Resource for Latest Information

◦ 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
11/17/2014 3

 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;
11/17/2014 4

 211.80 (b)
 Appropriately Handle & Store components
and drug product containers and closures to
prevent contamination.
11/17/2014 5

 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
11/17/2014 6

 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
11/17/2014 7

 211.82 ( b )
 Components, drug product containers, and
closures
◦ Store under quarantine
◦ Test or examine
◦ Store as per requirements of §211.80.
11/17/2014 8

 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
11/17/2014 9

 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.
11/17/2014 10

 211.84 (c )
◦ (4) Do not composite a sample if it is necessary to
sample a component from the top, middle, and
bottom of its container
11/17/2014 11

 211.84 (c )
◦ (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
11/17/2014 12

 211.84 (c )
◦ (6) Mark containers from which samples have been
taken to show that samples have been removed
from them.
11/17/2014 13

 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
11/17/2014 14

 211.84 (d ) ( 2)
 Test each component for conformity with all
written specifications for
◦ Purity
◦ Strength
◦ Quality
11/17/2014 15

 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.
11/17/2014 16

 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.
11/17/2014 17

 211.84 (d ) ( 4)
 Examine components microscopically when
appropriate
11/17/2014 18

 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
11/17/2014 19

 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
11/17/2014 20

 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
11/17/2014 21

 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
11/17/2014 22

 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
11/17/2014 23

 211.87
 Retesting or Reexamination
◦ After storage for long periods
◦ After exposure to air, heat or other conditions that
might adversely affect the lot∗
11/17/2014 24

 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
11/17/2014 25

 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.
11/17/2014 26

 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.
11/17/2014 27

 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
11/17/2014 28

 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.
11/17/2014 29

 This presentation is compiled from freely
available resource like the website of FDA.
“Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/17/2014 30

GMP's as per US FDA : Part E

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