GMP's as per US FDA : Part A

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 A 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

 Regulations for GMP’s for are described in
◦ Code of Federal Regulations
◦ Title 21
◦ Subchapter C
◦ Part 210 and part 211: Drugs for Humans & Animals
◦ Parts 600 to 680 : Biological products for Human Use
◦ Part 1271 : Drugs that are Human cells & Tissue based
products
11/17/2014 4

 Defined in 210.1 ( a)
 Regulations are given in parts 210 , 211, 225,
and 226
◦ 211 : Drugs for Humans & Animals
◦ 225 : Medicated Feeds
◦ 226 : Type A Medicated Articles
11/17/2014 5

 Sets Minimum current good manufacturing practice for
◦ Methods
◦ Facilities
◦ Controls
 To be used for
◦ Manufacture
◦ Processing
◦ Packing
◦ Holding
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 GMP’s assure that drug meets the requirements of
◦ safety
◦ Identity
◦ Strength
◦ Quality and purity characteristics
 that it purports or is represented to possess.
11/17/2014 7

 Defined in 210.1 (b)
◦ Implications of failure to comply part 211
◦ Such drugs are declared “adulterated”
 under section 501(a)(2)(B) of the act
◦ Drug is subjected to appropriate regulatory action
◦ Responsible person for the failure to comply, is also
subjected to regulatory action.
11/17/2014 8
Indian
GMP’s
does not
have this
provision

 Defined in 210.2 (a )
◦ If manufacturing involves only some operations
subject to the regulations in parts :
◦ 210 ,211, 225, 226 600 through 680and in part
1271 and not in others,
 Then comply with relevant regulations applicable.
11/17/2014 9

◦ Regulations in Part 600 to 680 , Part 1271 supplement
regulations in part 211
◦ They do not supersede the regulations in part 211
unless stated explicitly.
◦ In the event of a conflict the regulation specifically
applicable to the drug product in question shall
supersede the more general.
11/17/2014 10

 Defined in 210.2 (c) : Investigational Drugs
◦ Drugs used in Phase 1
 Described in §312.21(a) of this chapter
 Statutory requirements set forth in 21 U.S.C. 351(a)(2)(B).
◦ Part 211 requirements are not applicable for production of
such drugs
◦ Exemption not applicable if the drug has been used in a
phase 2 or phase 3 study,
11/17/2014 11

 Defined in 210.2 (c) : Investigational Drugs
◦ Exemption not applicable if the drug has been lawfully
marketed.
 In such cases the drug for use in the phase 1 study must
comply with part 211
11/17/2014 12

 Defined in Part 210.3
 Act means the Federal Food, Drug, and Cosmetic Act, as
amended (21 U.S.C. 301 et seq.).
11/17/2014 13

 Batch means
◦ A specific quantity of a drug or other material
◦ Intended to have uniform character
◦ Intended to have quality within specified limits
◦ Produced according to a single manufacturing order
◦ Produced during the same cycle of manufacture
11/17/2014 14

 Component means
◦ Any ingredient
◦ Intended for use in the manufacture of a drug product
◦ Includes also those that may not appear in final drug product
11/17/2014 15

◦ Drug product
◦ A finished dosage form
 e.g. tablet, capsule, solution, etc.,
◦ Contains an active drug ingredient
 Generally, but not necessarily
◦ Also or in association with inactive ingredients.
◦ Finished dosage form that does not contain an active ingredient
but is intended to be used as a placebo.
11/17/2014 16

 Active ingredient means any component intended to
◦ Furnish pharmacological activity
◦ Direct effect in the diagnosis , cure , mitigation , treatment or prevention of
disease
◦ Affect the structure or any function of the body of man or other animals
 Includes components intended to Furnish specified activity or
effect
◦ That may undergo chemical change in the manufacture of the drug product
◦ Be present in the drug product in a modified form
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 Inactive ingredient
◦ Any component other than an active ingredient.
11/17/2014 18

 In-process material
◦ Any material produced and used in the preparation of the drug
product.
 Fabricated
 Compounded
 Blended
 Derived by chemical reaction
11/17/2014 19

 Lot
◦ A batch or a specific identified portion of a batch
 Having uniform character and quality within specified limits
◦ In the case continuous process
◦ Specific identified amount produced in a unit of time or quantity
 Having uniform character and quality within specified limits
11/17/2014 20

 Lot Number Also known as control number, or batch number
◦ Any distinctive combination of
 Letters
 Numbers
 Symbols
 Any combination of them,
◦ Complete history can be determined from this number.
 Manufacture, processing, packing, holding, and distribution of a batch or lot
of drug product or other material
11/17/2014 21

 Manufacture, processing, packing, or holding
of a drug product includes
◦ Packaging
◦ Labeling operations,
◦ Testing
◦ Quality control of drug products
11/17/2014 22

 Medicated feed
◦ Any Type B or Type C medicated feed as defined in
§558.3 of this chapter.
◦ The feed contains one or more drugs
◦ Manufacture is subject to the requirements of part
225
11/17/2014 23

 Medicated Premix
◦ A Type A medicated article as defined in §558.3 of
this chapter.
◦ Contains one or more drugs
◦ The manufacture is subject to the requirements of
part 226
11/17/2014 24

 Quality control unit
◦ Any person
◦ Organizational element
◦ Designated by the firm to be responsible for the
duties relating to quality control.
11/17/2014 25

 Defined in Part 210.3 (c)
 Strength means:
◦ The concentration of the drug substance
 (e.g. weight/weight, weight/volume, or unit dose/volume basis), and/or
◦ The potency of the drug product
 Therapeutic activity indicated by
 Appropriate laboratory tests or
 Adequately developed and controlled clinical data
 (expressed, for example, in terms of units by reference to a standard).
11/17/2014 26

 Theoretical yield
◦ Quantity that would be produced
◦ At appropriate phase of manufacture, processing, or
packing
◦ Based upon the quantity of components to be used
◦ In the absence of any loss or error in actual production
11/17/2014 27

 Actual yield
◦ The quantity that is actually produced
◦ At any appropriate phase of manufacture,
processing, or packing
11/17/2014 28

 Percentage of theoretical yield
 The ratio of the actual yield to the theoretical
yield (at the same phase), stated as a percentage.
◦ (at any appropriate phase of manufacture, processing,
or packing of a particular drug product)
11/17/2014 29

 Acceptance criteria
◦ Product specifications
◦ Acceptance/rejection criteria
 acceptable quality level and unacceptable quality level, with an
associated sampling plan
◦ Necessary for making a decision to accept or reject a lot or
batch
 (or any other convenient subgroups of manufactured units).
11/17/2014 30

 Representative sample
◦ A sample
◦ Consisting of a number of units
◦ Drawn based on rational criteria
 e.g. random sampling
◦ Intended to assure that the sample accurately portrays
the material being sampled.
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 Gang-printed labeling
◦ Labeling from a sheet of material on which more
than one item of labeling is printed.
11/17/2014 32

◦ These are minimum requirements
◦ Applicable to drug products for Humans & Animals
◦ Not applicable to positron emission tomography
drugs
11/17/2014 33

◦ Regulations in Part 600 to 680 , Part 1271 supplement
regulations in part 211
◦ They do not supersede the regulations in part 211
unless stated explicitly.
◦ In the event of a conflict the regulation specifically
applicable to the drug product in question shall
supersede the more general.
11/17/2014 34

 Defined in 211.1 (c)
◦ Part 211 requirements shall not be enforced for
OTC drug products if
 Products and all their ingredients are ordinarily
marketed and consumed as human foods
11/17/2014 35

 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 36

GMP's as per US FDA : Part A

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