21CFR 210 21 CFR 211

1. 21 CFR, PART 210 AND 211
CURRENT GOOD
MANUFACTURING PRACTICE
- BY AARTI VATSA
- (MPHARM, DRA)

2. FOOD AND DRUG ADMINSTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
- UNITED STATES OF AMERICA
 21 CFR
 21- Title NUMBER
 CFR- Code of Federal Regulation

3. 21 CFR
 PART 210: c GMP in Manufacturing, Processing,
Packing or Holding of drugs.
 PART 211: c GMP for Finished Pharmaceuticals.
Part 210
Part 211

4. 21 CFR PARTS 210 AND 211
 PART 210.1: Status of current good manufacturing practices.
 PART 210.2: Applicability of current good manufacturing practices.
 PART 210.3: Definitions
 PART 211: Sub part A- General Provisions
 PART 211: Sub part B- Organization and personnel.
 PART 211: Sub part C- Building and facilities.
 PART 211: Sub part D- Equipment.
 PART 211: Sub part E- control of components and drug product containers and closures.
 PART 211: Sub part F- Production and Process control.
 PART 211: Sub part G- Packing and Labeling control.
 PART 211: Sub part H- Holding and Distribution
 PART 211: Sub part I– Laboratory Controls
 PART 211 Sub part J- Records and Reports.
 PART 211: Sub part K– Returned and Salvaged Drug Products..

5. 21 CFR PART
210
 The regulations set forth in this part and in parts
211 through 226 of this chapter contain the
minimum c GMP for manufacturing, processing,
or holding of a drug product meets the
specification.
PART 210.1: STATUS OF c
GMP Regulations

6.  The Regulation in this part may pertain to a biological
product for human use shall be consider as supplement.
 If the person engages in only some operations subject to the
regulation in this part that person need only comply with
these regulations applicable to the operations in which he or
she is engaged.
210.2
APPLICABILTY
OF CGMP
REGUKATIONS

7. 21 CFR PART 210.3
DEFINATIONS COVER IN THIS PART

8. DEFINATIONS
 DRUG PRODUCT/ FINISHED PRODUCT: A finished dosage form, for
example, tablet, capsule, solutions, etc. that contains an active drug
ingredient generally, but not necessarily, in association with inactive
ingredients.
 ACTIVE PHARMACEUTICAL INGREDIENT: Any substance produced by
chemical synthesis, fermentation, recombinant DNA processes, or
recovery from natural materials that is indented fro use as a component
in a drug product or a substance that is repackaged or labeled for drug
use.

9. DEFINATIONS
 Batch: A specific quantity of a drug or other material that is intended to have
uniform character and quality, within specified limits, and is produced according
to a single manufacturing order during the same cycle of manufacture.
 Lot No/ Batch No: Any distinctive combination of letters, numbers, or symbols,
or any combination of them, form which the complete history of the
manufacture, processing, packing holding, and distribution of a batch or lot of
drug product or other material can be determined.
 In-process testing: Testing performed during production to monitor and, if
necessary, adjust the process to ensure that the drug substance or intermediate
conforms to its specifications.

10. DEFINATIONS
 Intermediate: Any substance, whether isolated or not, that is produced by
chemical, physical, or biological action at some stage in the production of a
drug substance and that is subsequently used at another stage of production.
 Quality Control Unit: Any person or organizational element designated by the
firm to be responsible of the duties relating to quality control.
 Quarantine : The status or physical isolation of raw materials, intermediates,
packaging materials, or drug substances to preclude their use pending a
decision on their disposition.
 Recovery : The appropriate processing of materials to make them suitable for
further use.
 Reprocess : Introducing previously processed material, which did not conform to
standards or specifications, back into the process and repeating steps that are
already part of the normal manufacturing process.

11. DEFINATIONS
 Rejected material : Any material or item that has been determined to be
unacceptable for the specified use.
 Returned goods: Any material that has been rejected/ returned by the user will be
called as returned goods.
 Theoretical yield: The quantity that would be produced at any appropriate phase of
manufacture, processing, or packing of a particular drug product, based upon the
quantity of components to be used, in the absence of any loss or error in actual
production.
 Actual yield: The quantity that is actually produced at any appropriate phase of
manufacture, processing, or packing of a particular drug product.
 Percentage of theoretical yield: The ratio of the actual yield to the theoretical yield,
stated as a percentage.

12. DEFINATIONS
 Cross contamination : An undesired introduction of one or more BPC materials
into another.
 Expiry/ Expiration date : A date before which the drug substance meets all
specifications and after which the drug substance can no longer be used, This
date shall be assigned based on the stability of, or experience with, the drug
substance. An expiration date is a regulatory requirement unique to antibiotics.
 Retest Period: The period of time during which the drug substance can be
considered to remain which the specification and therefore acceptable for use in
the manufacturing of a given drug product, provided that it has been stored
under the defined conditions; after this period, the batch should be re-tested for
compliance with specification and then used immediately.

13. DEFINATIONS
 Shelf life/ Expiration dating period: The time interval that a drug product is
expected to remain within the approved shelf-life specification provided that it
is stored under the conditions defined on the label in the proposed containers
and closure.
 Packaging Material: Any or all materials used for the storage or shipment of a
drug substance or intermediate.
 Validation : A documented program that provides a high degree of assurance
that a specific process, method, or system will consistently produce a result
meeting predetermined acceptance criteria.
 Process Suitability: The Established Capacity Of The Manufacturing Process To
Produce Effective And Reproducible Results Consistently.

14. DEFINATIONS
 Accelerated testing : Studies designated to increase the rate of chemical
degradation or physical change of an active drug substance or drug product by
using exaggerated storage conditions as part of the formal, definitive, storage
program.
 Long-term (real time) Testing: Stability evaluation of the physical, chemical,
biological, and microbiological characteristics of a drug product and a drug
substance, covering the expected duration of the shelf life and retest period,
which are claimed in the submission and will appear on the labeling.

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