21 CFR, Part 210 and 211 current.pptx

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. L ong-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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