GMP's as per US FDA

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 G 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

 211.122 (a)
 Ensure that there are written procedures for labeling and
packaging materials
◦ Receipt
◦ Identification
◦ Storage
◦ Handling
◦ Sampling
◦ Examination, and/or testing
 Follow written procedure
11/17/2014 4

 211.122 (a)
 Labeling and packaging materials
◦ Sample representatively
◦ Examine or test
◦ Perform these after receipt & before use
11/17/2014 5

 211.122 (b)
 Labeling or packaging materials
◦ Release materials meeting written specifications
◦ Reject materials not meeting such specifications
 Prevent their use in operations
11/17/2014 6

 211.122 (c)
 Records
◦ Maintain for each shipment
◦ Maintain for each different material
◦ Records should indicate
 Receipt
 Examination or testing
 Whether accepted or rejected
11/17/2014 7

 211.122 (d)
 Store separately labels and other labeling materials for
each different
◦ Drug product
◦ Strength
◦ Dosage form
◦ Quantity of contents
 Identify suitably
 Limit access to the storage area to authorized personnel
11/17/2014 8

 211.122 (e)
 Destroy obsolete and outdated
 Labels
 Labeling
 Other packaging
11/17/2014 9

 211.122 ( f)
 Use of gang-printed labeling for following is prohibited.
◦ Different drug products
◦ Different strengths of same drug products
◦ Different net contents of the same drug product
 Exception
◦ Labeling from gang-printed sheets is adequately differentiated by
 Size
 Shape
 Color
11/17/2014 10

 211.122 (g)
 Include special control procedures when cut
labeling is used for
◦ Immediate container labels
◦ Individual unit cartons
◦ Multiunit cartons containing immediate containers
that are not packaged in individual unit cartons
11/17/2014 11

 211.122 (g) (1)
 Dedicate labeling and packaging lines to each
◦ Different strength
◦ Different drug product
11/17/2014 12

 211.122 (g) (2)
 Use
◦ Appropriate electronic or electromechanical devices
◦ Conduct a 100-percent examination with these
equipment
◦ Inspection should check for correct labeling during
or after completion of finishing operations
11/17/2014 13

 211.122 (g) (3) alternative to 211.122 (g) (2)
 Conduct visual inspection for hand-applied labeling.
 Examine 100-percent for correct labeling during or
after completion of finishing operations
 Inspection should be performed by one person
 Second person should conduct independent
verification
11/17/2014 14

 211.122 (g) (4)
 Physically prevent incorrect labeling by use of
◦ Any automated technique
◦ Differentiation by labeling size and shape
11/17/2014 15

 211.122 ( h)
 Printing devices
◦ Monitor all devises associated with manufacturing
lines
◦ Monitor to assure that all imprinting conforms to
the print specified in the batch production record
11/17/2014 16

 211.125
 (a) Exercise strict control over labeling issued
 (b) Carefully examine labeling materials
◦ All material issued for a batch
◦ Examine for
 Identity
 Conformity to the labeling specified in the master or batch
production records.
11/17/2014 17

 211.125 ( c )
 Provide written procedures which addresses
◦ Reconciliation of the quantities of labeling issued, used,
and returned
◦ Limits for reconciliation based on historical data
◦ Evaluation of discrepancies found between the quantity
of drug product finished and the quantity of labeling
issued
11/17/2014 18

 211.125 ( c )
◦ Investigation of such discrepancies in accordance with
§211.192.
 Labeling reconciliation not required if for cut or
roll labeling if a 100-percent examination for
correct labeling is performed in accordance with
§211.122(g)(2).
11/17/2014 19

 211.125
 (d) Destroy all excess labeling bearing lot or
control numbers.
 (e) Returned labeling
◦ Store & maintain to prevent mix-ups
◦ Provide proper identification
11/17/2014 20

 211.125 (f)
 Procedures for issuance of labeling
◦ Written procedures
◦ Provide sufficient detail
 Follow written procedures
11/17/2014 21

 211.130
 Provide written procedures
◦ Design them to assure that correct packaging
materials are used
◦ Follow such written procedures
◦ These procedures shall incorporate the following
features:
11/17/2014 22

 211.130 ( a)
 Prevention of mix-ups and cross-
contamination by
◦ Physical Separation
◦ Spatial separation
11/17/2014 23

 211.130 ( b)
 Filled drug product containers
◦ May be set aside and held in unlabeled condition for
future labeling
◦ Prevent mislabelling of individual containers, lots, or
portions of lots
◦ Identify & Handle appropriately
◦ Identification of each individual container is not essential
11/17/2014 24

 211.130 ( b)
 Filled drug product containers
◦ Identification should include
 Name
 Strength
 Quantity of contents
 Lot or control number of each container
11/17/2014 25

 211.130 (c)
 Identification of the drug product
◦ Identify with a lot or control number
◦ This should be traceable to the history of the
manufacture and control of the batch.
11/17/2014 26

 211.130( d)
 Examination of Materials
◦ All packaging and labeling materials
◦ Examination for suitability and correctness before
packaging operations
◦ Documentation of such examination in the batch
production record.
11/17/2014 27

 211.130( e )
 Inspection of the packaging and labeling facilities
◦ Perform immediately before use
◦ Assure that all drug products have been removed from previous
operations
◦ Assure that packaging and labeling materials not suitable for
subsequent operations have been removed
◦ Document results of inspection in the batch production records
11/17/2014 28

 211.132 (a) General
 FDA has authority to establish a uniform requirement
for tamper-evident packaging of OTC drug products
 This improves the security of OTC drug packaging
 Helps to assure the safety and effectiveness of OTC
drug products
11/17/2014 29

 211.132 (a) General
 OTC drug product∗ for retail sale
◦ Not packaged in a tamper-resistant package
◦ Not properly labelled under this section
◦ Adulterated as per section 501 of the act
◦ Misbranded as per section 502 of the act
 ∗(except a dermatological, dentifrice, insulin, or lozenge
product)
11/17/2014 30

 211.132 ( b) (1)
 Requirements for tamper-evident package.
◦ OTC drug product∗ for retail sale shall be packaged in a tamper-
evident package
◦ A tamper-evident package is one having one or more indicators or
barriers to entry which, if breached or missing, can reasonably be
expected to provide visible evidence to consumers that tampering
has occurred.
◦ ∗ (except a dermatological, dentifrice, insulin, or lozenge product)
11/17/2014 31

 211.132 ( b) (1)
 A tamper-evident package
◦ Package having one or more indicators or barriers
to entry
◦ These provide visible evidence to consumers that
tampering has occurred if breached or missing
11/17/2014 32

 211.132 ( b) ( 1 )
 Distinctive by design∗ requirement for the package
◦ ∗Packaging that cannot be duplicated with commonly available
materials or through commonly available processes
◦ To reduce the likelihood of tampering
◦ To increase the likelihood that consumers will discover if a
product has been tampered with
11/17/2014 33

 211.132 ( b) ( 1 )
 Distinctive by design requirement for the
package
◦ Use of one or more indicators or barriers to entry that
employ an identifying characteristic
 (e.g., a pattern, name, registered trademark, logo, or
picture).
11/17/2014 34

 211.132 ( b) ( 1 )
 Requirements for tamper-evident package may involve
◦ Immediate-container and closure system or
◦ Secondary-container or carton system or
◦ Any combination of systems intended to provide a visual
indication of package integrity.
◦ The tamper-evident feature shall be designed to and shall remain
intact when handled in a reasonable manner during manufacture,
distribution, and retail display.
11/17/2014 35

 211.132 ( b) ( 2 )
 In addition to the tamper-evident packaging
requirement
◦ Any two-piece, hard gelatin capsule must be sealed
using an acceptable tamper-evident technology.
11/17/2014 36

 211.132 (c ) ( 1 )
 Alert consumers of tamper-evident package ∗ by
statements given in subsequent slides :
 ∗except ammonia inhalant in crushable glass ampules,
containers of compressed medical oxygen, or aerosol
products that depend upon the power of a liquefied or
compressed gas to expel the contents from the container)
11/17/2014 37

 211.132 (c ) ( 1 )
 Alert consumers of tamper-evident package ∗ by
statement that :
◦ (i) Identifies all tamper-evident feature(s) and any capsule sealing
technologies used to comply with paragraph (b) of this section;
◦ (ii) Is prominently placed on the package; and
◦ (iii) Is so placed that it will be unaffected if the tamper-evident
feature of the package is breached or missing.
11/17/2014 38

 211.132 ( C ) ( 2 )
 Refer identifying characteristic in the labelling
statement
◦ For example, the labeling statement on a bottle
with a shrink band could say “For your protection,
this bottle has an imprinted seal around the neck.”
11/17/2014 39

 211.132 ( d)
 Request for exemptions from packaging and labeling
requirements.
◦ A manufacturer or packer may request an exemption from the
packaging and labeling requirements of this section.
◦ A request for an exemption is required to be submitted in the
form of a citizen petition under §10.30 of this chapter
◦ Clearly identify on the envelope as a “Request for Exemption from
the Tamper-Evident Packaging Rule.”
11/17/2014 40

 211.132 ( d)
 The petition is required to contain the following:
◦ (1) The name of the drug product or, if the petition seeks an exemption for a drug
class, the name of the drug class, and a list of products within that class.
◦ (2) The reasons that the drug product's compliance with the tamper-evident
packaging or labeling requirements of this section is unnecessary or cannot be
achieved.
◦ (3) A description of alternative steps that are available, or that the petitioner has
already taken, to reduce the likelihood that the product or drug class will be the
subject of malicious adulteration.
◦ (4) Other information justifying an exemption.
11/17/2014 41

 211.132 ( e )
 OTC drug products subject to approved new drug applications.
◦ Provide the agency with notification of changes in packaging and labeling
to comply with the requirements of this section.
◦ Changes in packaging and labeling required by this regulation may be
made before FDA approval, as provided under §314.70(c) of this chapter.
◦ Manufacturing changes by which capsules are to be sealed require prior
FDA approval under §314.70(b) of this chapter.
11/17/2014 42

 211.132 ( f )
 Poison Prevention Packaging Act of 1970.
◦ This section does not affect any requirements for
“special packaging” as defined under §310.3(l) of
this chapter and required under the Poison
Prevention Packaging Act of 1970.
11/17/2014 43

 211.134 ( a )
 Packaged and labelled products
◦ Examine during finishing operations
◦ Provide assurance that containers and packages in
the lot have the correct label.
11/17/2014 44

 211.134 ( b)
 Collect a representative sample of units at the
completion of finishing operations
 Visually examine sample for correct labeling
11/17/2014 45

 211.134 ( c )
 Record results of these examinations in the
batch production or control records.
11/17/2014 46

 211.137 (a)
 Drug product shall bear an expiration date
◦ This will assure that a drug product meets applicable standards of
 Identity
 Strength
 Quality
 Purity
◦ Determine expiration date by appropriate stability testing
described in §211.166.
11/17/2014 47

 211.137 ( b )
 Expiration dates
◦ Relate to any storage conditions stated on the
labeling
◦ Determine by stability studies described in
§211.166.
11/17/2014 48

 211.137 ( c )
 Products to be reconstituted
◦ Labeling shall bear expiration information for both
the reconstituted and unreconstituted drug
products
11/17/2014 49

 211.137 ( d )
 Expiration dates shall appear on labeling in
accordance with the requirements of §201.17
of this chapter.
11/17/2014 50

 211.137 ( e )
 Homeopathic drug products shall be exempt
from the requirements of this section.
11/17/2014 51

 211.137 ( f )
 Allergenic extracts that are labeled “No U.S.
Standard of Potency” are exempt from the
requirements of this section.
11/17/2014 52

 211.137 (g)
 New drug products for investigational use
◦ Exempt from the requirements of this section
◦ Exemption applicable if they meet standards or
specifications as demonstrated by stability studies during
their use in clinical investigations.
◦ Labeling shall bear expiration information for the
reconstituted drug product if product requires
reconstitution .
11/17/2014 53

 211.137 ( h )
 OTC drug products
 Requirements in this section shall not be
enforced if
◦ Labeling does not bear dosage limitations and
◦ They are stable for at least 3 years as supported by
appropriate stability data.
11/17/2014 54

 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 55

GMP's as per US FDA

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