Definitions related to Cleaning Validation:
Procedure: The cleaning validation activity shall be performed in the three stages such as design, cleaning validation, and maintenance of validated state. Detailed flow chart of the cleaning validation activity as given below,
1. Acceptable Daily Exposure (ADE)/Permissible Daily Exposure (PDE): A dose that is unlikely to cause an adverse effect if an individual is exposed, at or below this dose everyday for a lifetime.
2. Cleaning Agent: The solution or solvent (Organic/Inorganic) used in the cleaning process. Examples of cleaning agents are water, organic solvent etc.
3. Clean Equipment Hold Time (CEHT): Time from the end of the cleaning process until the equipment used again.
4. Cleaning Process: A process that is used to remove previous product residue, process related contaminant from the process equipment such that equipment can be safely used for subsequent product manufacture.
5. Cleaning Validation: Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product, impurities & cleaning agents ( if applicable) used in the equipment to below the scientifically justified acceptance criteria.
6. Cleaning Verification: Collection of evidence through chemical/microbial/visual evaluation to show that the residues of the previous product, bioburden, nitrosamine impurities and cleaning agents (if applicable) have been reduced the below scientifically justified acceptance criteria.
7. Swab Sample: The technique to collect sample by using swab to detect/determine the level of contamination or residue per given surface area on the equipment surfaces after cleaning.
8. Residue: Any substance which can be seen with the naked eye or by using the aid of a light, that smudges, smears, or comes off the equipment surface
9. Visually clean: Visual cleanliness is the absence of any visible residue in the equipment after cleaning under illuminated conditions as can be seen by a qualified visual inspector with naked eye.
10. Visual Inspection: A detailed inspection of equipment, utensil or processing area under illuminated conditions through naked eye for the presence of residue after the cleaning has been completed.
11. Non-Product contact Surfaces: A non-product contact surface is one that would never be in contact with the product or in direct or indirect product contact surfaces (e.g., motor, control panel of equipment, the exterior of equipment).
12. Product Contact Surfaces: Equipment surfaces that have direct contact with the product.
13. Shared Product Contact Surfaces: A common surface area shared between equipment train that is in direct product contact with manufactured products.
14. Rouge: Oxidation of the equipment surface.
15. Cleaning Validation Report (CVR): The document which includes an assessment, evaluation, and conclusion of the cleaning validation study results, conducted as prescribed in the associated CVP.
16. Contaminant: Drug product residue, reactant, genotoxic impurities, cleaning agent, bioburden or foreign matter that, at a high enough level after cleaning, may potentially contaminate the equipment surfaces or the next drug product to be manufactured.
17. Facility Surfaces: Non-product contact surfaces that are not in direct proximity to product contact equipment such as floors, walls, counters, and shielding.
18. Health-based Exposure Limit (HBEL): A limit based strictly on a toxicological evaluation addressing patient safety. Typically expressed as Acceptable Daily Exposure (ADE) / Permitted Daily Exposure (PDE). ADE and PDE are effectively synonymous.
19. Indirect Product Contact Surfaces: An indirect product contact surface is one that directly contacts a product contact surface and can transfer residues to the next product therefore, there is a lower risk of cross contamination as compared to direct product contact surfaces (for example, spanner, scissors, etc.).
20. Periodic Monitoring: Periodic monitoring of the cleaning process to prove that the cleaning process remains in state of control through out the lifecycle.
21. Cleaning Validation Master Plan (CVMP): Tile CVMP documents tile firm’s / manufacturing site’s overall philosophy and approach to be used for establishing and maintaining tile cleaning process(es). It defines the scope, plan and strategy of the cleaning validation program.
22. Cleaning Validation Protocol (CVP): Tile document justifying tile study design and describes tile procedure for conducting, analyzing, and recording tile results of cleaning validation studies.
23. Stain: Apparent visual residue that close not come off of the equipment after cleaning.
24. Type-A cleaning: Equipment dedusting/flushing is performed at the Clay’s end / Batch Changeover of the same product and strength or ascending strength (provided the color is the same), to make the equipment free from loosely stuck powder (gross residue removal).
25.Type-B cleaning: Equipment cleaning is performed during the changeover of products with different actives, color/descending potency or after any major maintenance of contact parts or when the next drug product and the batch are not known.
26. Acceptance Criteria: Numerical limits, ranges, or other suitable measures for acceptance of test results.
27. Acceptable Limit: The maximum acceptable concentration of an impurity in a drug substance derived from the Acceptable Intake (Al) based on TOSO or Carcinogenicity Potency Categorization Approach (CPCA) and the maximum daily Close of the drug.
Definitions Related to Cleaning Validation
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