GMP's as per US FDA : Part D

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 D 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

 211.63
 Equipment∗ shall
◦ Be of appropriate design
◦ Be of adequate size
◦ Be suitably located
◦ Facilitate operations for its intended use
◦ Facilitate its cleaning and maintenance.
 ∗ used in the manufacture, processing, packing, or holding of a drug
product
11/17/2014 4

 211.65 (a)
 Equipment∗ shall be constructed so that surfaces shall not
◦ Be reactive
◦ Be additive
◦ Be absorptive
 So as to alter the safety, identity, strength, quality, or
purity of the drug product beyond the official or other
established requirements.
 ∗ that contact components, in-process materials, or drug products
11/17/2014 5

 211.65 (b)
 Substances such as lubricants or coolants shall not come into
contact with
◦ Components
◦ Drug product containers
◦ Closures
◦ In-process materials
◦ Drug products
◦ So as to alter the safety, identity, strength, quality, or purity of the drug
product beyond the official or other established requirements.
11/17/2014 6

 211.67 (a)
 Clean & Maintain equipment and utensils
 Base this on the nature of the drug
 Sanitize and/or sterilize at appropriate intervals
◦ To prevent malfunctions or contamination
 That would alter the safety, identity, strength, quality, or
purity of the drug product beyond the official or other
established requirements.
11/17/2014 7

 211.67 (b)
 Establish written procedures for
◦ Equipment∗ cleaning
◦ Equipment ∗ maintenance
◦ Utensils ∗ cleaning
 Follow written procedures
 ∗ used in the manufacture, processing, packing, or holding
of a drug product.
11/17/2014 8

 211.67 (b)
 Include at least following in the procedure to Assure
proper cleaning and maintenance
◦ (1) Assignment of responsibility for cleaning and
maintaining equipment;
◦ (2) Maintenance and cleaning schedules, sanitizing
schedules;
11/17/2014 9

 211.67 (b) (3)
◦ Detailed cleaning Methods
◦ Equipment used for cleaning
◦ Materials used for cleaning
◦ Methods of disassembling process equipment
◦ Methods of reassembling process equipment
11/17/2014 10

 211.67 (b)
 (4) Removal or obliteration of previous batch identification;
 (5) Protection of clean equipment from contamination prior to
use;
 (6) Inspection of equipment for cleanliness immediately before
use.
11/17/2014 11

 211.67 (c)
 Maintain records of : (§§211.180 and 211.182.)
 Maintenance
 Cleaning
 Sanitizing
 Inspection
11/17/2014 12

 211.68 (a)
 Following equipment which will perform satisfactorily
can be used in manufacture
 Automatic Equipment
 Mechanical Equipment
 Electronic Equipment
 Other types of Equipment
 Computers, or related systems
11/17/2014 13

 211.68 (a)
 If such equipment is used perform routinely
 Calibrations
 Inspections
 Check to assure proper performance
 Maintain written records of calibration checks and
inspections
11/17/2014 14

 211.68 (b)
 Ensure appropriate controls
 Ensure that only authorized personnel make changes in
master production and control records
 Check input to and output from the computer for
accuracy.
 Base the frequency of input/output verification on the
complexity and reliability of the computer system.
11/17/2014 15

 211.68 (b)
 Maintain a backup file of data entered into the
computer or related system
 Exception
 Where certain data, such as calculations performed in
connection with laboratory analysis, are eliminated by
computerization or other automated processes.
11/17/2014 16

 211.68 (b)
 In such instances maintain a written record of the
program along with appropriate validation data
11/17/2014 17

 211.68 (b)
 Maintain hard copy or alternative systems,
 Duplicates
 Tapes
 Microfilm
11/17/2014 18

 211.68 (b)
 Ensure that backup data are
 Exact
 Secure from
 Alteration
 Inadvertent erasures
 Loss
11/17/2014 19

 211.68 (c)
 GMP’s require performance of operation by one person &
checking by another. §§211.101(c) or (d), 211.103, 211.182, or
211.188(b)(11)
 Automated equipment can meet these requirements if
 The equipment is used in conformity with this section and
 One person checks that the equipment properly performed the
operation
11/17/2014 20

 211.72 (c)
 Ensure that filters∗ for liquid filtration do not release
fibers into such products.
 Fiber-releasing filters may be used when it is not
possible to manufacture such products without the
use of these filters.
11/17/2014 21

 211.72 (c)
 If such fibres are used
 Use an additional nonfiber-releasing filter having a maximum
nominal pore size rating of 0.2 micron (0.45 micron if the
manufacturing conditions so dictate) to reduce the content of
particles in the injectable drug product.
 The use of an asbestos-containing filter is prohibited.
 ∗ used in the manufacture, processing, or packing of injectable
drug products intended for human use
11/17/2014 22

 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 23

GMP's as per US FDA : Part D

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