GMP's as per US FDA : Part F

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 F 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

 211.100 (a)
 Written procedures
◦ Production and process control
◦ Designed to assure that the drug products have the
 Identity
 Strength
 Quality
 Purity
◦ They purport or are represented to possess.
11/17/2014 4

 211.100 (a)
◦ Shall include all requirements in this subpart.
◦ Shall be drafted, reviewed, and approved by the
appropriate organizational units
◦ Shall be reviewed and approved by the quality
control unit
11/17/2014 5

 211.100 (b)
◦ Follow written production and process control
procedures
◦ Document at the time of performance.
◦ Record & Justify any deviation from the written
procedures
11/17/2014 6

 211.101
 Include following in written production and control
procedures
 This is will assure that the drug products produced have
the
◦ Identity
◦ Strength
◦ Quality
◦ Purity
11/17/2014 7

 211.101
 Ensure that written production and control
procedures address following requirements:
 (a) Batch formulation needs to provide not
less than 100 percent of the labelled amount
of active ingredient.
11/17/2014 8

 211.101
 (b) Weighing , measuring, or subdivision of drug product
component as required.
 Identification of a new container if a component is removed from
the original container with
◦ (1) Component name or item code;
◦ (2) Receiving or control number;
◦ (3) Weight or measure in new container;
◦ (4) Batch for which component was dispensed, including its product name,
strength, and lot number.
11/17/2014 9

 211.101
 c) Supervision of weighing, measuring, or subdividing operations for
components.
 Examination of each container of component dispensed by a second
person to assure that:
◦ (1) The component was released by the quality control unit;
◦ (2) The weight or measure is correct as stated in the batch production records;
◦ (3) The containers are properly identified.
 Verification by one person if operations are performed by automated
equipment under §211.68
11/17/2014 10

 211.101 (d)
 Addition of each component to the batch by
one person and verification by second person
 Verification by one person if the components
are added by automated equipment under
§211.68.
11/17/2014 11

 211.103
 Calculate actual yields and percentages of theoretical
yield
 Determine this at the conclusion of each phase of
◦ Manufacturing
◦ Processing
◦ Packaging
◦ Holding of the drug product
11/17/2014 12

 211.103
 Independently verify yield calculations by a
second person
 Independently verify yield calculations if
calculated by automated equipment under
§211.68,
11/17/2014 13

 211.105 (a)
 Identify all
◦ Compounding and storage containers
◦ Processing lines
◦ Major equipment used
 Identify at all times to indicate
◦ Contents
◦ Phase of processing of the batch
11/17/2014 14

 211.105 (b)
 Major equipment
◦ Identify by a distinctive identification number or code
◦ Record in batch production record
◦ Correlate specific equipment to each batch
◦ If only one type of equipment exists the name of the
equipment may be used
11/17/2014 15

 211.110 (a)
 Establish written procedures for
◦ In-process controls,
◦ Tests
◦ Examinations
◦ Sampling
 Main objective is to assure batch uniformity and integrity
 Follow written procedures
11/17/2014 16

 211.110 (a)
 Establish control procedures to
◦ Monitor the output
◦ Validate the performance of manufacturing processes
◦ Control variability of in-process material and the drug
product.
◦ Control procedures should include
11/17/2014 17

 211.110 (a)
◦ Control procedures should include
◦ 1) Tablet or capsule weight variation
◦ (2) Disintegration time
◦ (3) Adequacy of mixing to assure uniformity and homogeneity
◦ (4) Dissolution time and rate
◦ (5) Clarity, completeness, or pH of solutions
◦ (6) Bioburden testing
11/17/2014 18

 211.110 (b)
 In-process specifications
◦ Valid
◦ Consistent with drug product final specifications
◦ Derived from previous acceptable process average
◦ Derived from process variability estimates
◦ Determined by the application of suitable statistical
procedures
11/17/2014 19

 211.110 (b)
 In-process specifications
◦ Examination and testing of samples
◦ Should assure that the drug product and in-process
material conform to specifications
11/17/2014 20

 211.110 (c)
 Testing of In-process materials
◦ Identity
◦ Strength
◦ Quality
◦ Purity as appropriate
◦ Approved or rejected by the quality control unit, during the production
process
 e.g., at commencement or completion of significant phases or after storage
for long periods.
11/17/2014 21

 211.110 (d)
 Rejected in-process materials
◦ Identify
◦ Control properly
◦ Quarantine
◦ Prevent their use in manufacturing or processing
11/17/2014 22

 211.111
 Establish time limits for the completion of each phase of
production
 This ensures the quality of the drug product.
 Justify any deviation from established time limits
 Document such deviation
 Such deviations should not compromise the quality of the
drug product.
11/17/2014 23

 211.113 (a)
 Establish written procedures
 Design procedures to prevent contamination
with oobjectionable organisms∗
 ∗ in drug products not required to be sterile
11/17/2014 24

 211.113 (b)
 Design procedures to prevent microbiological
contamination∗
 Validate all aseptic and sterilization processes
 ∗of drug products purporting to be sterile
11/17/2014 25

 211.113 (a)
 Describe system for reprocessing batches that do not
conform to standards or specifications
 Describe steps to ensure that the reprocessed
batches will conform with all established standards,
specifications, and characteristics.
11/17/2014 26

 211.113 (b)
 Do not reprocess without the review and
approval of the quality control unit.
11/17/2014 27

 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 28

GMP's as per US FDA : Part F

More Related Content

What's hot

Viewers also liked

Similar to GMP's as per US FDA : Part F

More from GMP EDUCATION : Not for Profit Organization

Recently uploaded

GMP's as per US FDA : Part F