Cleaning Validation – Glossary of Terms

Cleaning Validation

Glossary of Terms
1 Acceptable daily intake An amount of a substance administered or consumed on a daily basis that will not produce a pharmacological or toxic response
2 Analyte Substance for which an analysis is being performed
3 API Active pharmaceutical ingredient
4 Automated cleaning A cleaning procedure which relies on a sequence of programmed, reproducible steps (usually via mechanical and/or electronic devices)
5 Batch production A series of unit operations performed according to a single manufacturing order during the same cycle of manufacture to produce a specific quantity of a drug having uniform character and quality within specified limits
6 Blank Analytical method control sample used to establish a baseline for the result, e.g., as in a titration where one or two drops of the titrant must be added to the blank to cause an indicator color change
7 Bulk pharmaceutical Generally known as bulk pharmaceutical chemicals; also called primary pharmaceuticals or active pharmaceutical ingredients
8 Campaign Processing of more than one product in the same facility and/or equipment in a sequential manner; only one product is present in any one  manufacturing area of the facility at a time
9 CGMP Current Good Manufacturing Practices
10 Change control A documented system for reviewing proposed or actual changes that might affect a validated system or process; change control includes the determination of any corrective action required to ensure that the system remains in a validated state
11 Change-over Actions required for switching multi-product equipment and facilities from one product to another
12 Clean (v.) The implementation of procedures to render a piece of equipment,
or a system, free of adulterants and contaminants
13. Clean (v.) Visually clean – absence of materials which would adulterate a product when inspected with the eyes
Detectably clean – absence of materials which would adulterate a product down to the level of detection
Chemically clean – absence of all chemicals which would adulterate a product
14. Clean-in-place (CIP) Cleaning without the need to disassemble equipment (may be either automatic or manual)
15. CIP system A system, usually automatic, used to clean equipment in place
16. Clean-out-of-place
the cleaning performed, usually manually, after disassembly of equipment or a system
17. COP system A system which may be automatic, semi-automatic or manual, used to clean equipment out of place, e.g., a parts washer
18. Cleaning agent Usually a detergent or surfactant that reduces the surface tension of a solvent to increase its effectiveness
19. Cleaning validation Demonstrating that cleaning results are consistent and reproducible, usually by sampling critical and representative sites on the equipment after cleaning
20. Contaminant Extraneous substance that exists in a product
21. Continuous process A series of operations performed according to a manufacturing order so as to provide a steady stream of a drug having uniform character and quality within specified limits
22. Control parameters those operating variables that can be assigned values that are used to regulate a process
23. Coverage The exposure of equipment surface area to the cleaning process
24. Critical site area of a piece of equipment on which residual materials are trapped or concentrated (e.g., because of location, surface or equipment design) and which is likely to contribute all of the contamination to a single dose (i.e., “hot spot”)
25. Dead leg A pipe with restricted flow or agitation exceeding the length of six pipe diameters
26. Dedicated equipment Equipment that is to be utilized for a single product or product family
27. Degradation Breakdown of material during manufacture or after exposure to the cleaning process
28. depyrogenation removal or destruction of pyrogens
29. Detergent A synthetic wetting agent and emulsifier that can be added to a solvent to improve its cleaning efficiency
30. Disinfection To adequately treat equipment, containers, or utensils by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms
31. Endotoxin lipopolysaccharide, usually from gram negative bacteria
32. Equipment grouping Equipment closely related by design, as to be considered the same for the purposes of cleaning
33. Equipment train The sequence of equipment through which a product is produced or processed
34. Final rinse The last rinse of a piece of equipment during the cleaning procedure
35. Impingement To cause to strike
36. Impurity Any extraneous substance or contaminant present in the drug substance or drug product
37. LD50 The dose resulting in a fifty percent mortality of the test animal
38. Largest daily dose Maximum daily dose of the next product to be produced in the equipment train
39. Limit A prescribed maximum and/or minimum tolerance
40. Limit of detection The lowest concentration of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions
41. Limit of quantitation The lowest concentration of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions
42. Major equipment Any process equipment which is uniquely identified within the drug product batch record (e.g., autoclave, batch tank, blender, encapsulator, filler, tablet press)
43. Manual cleaning A cleaning procedure requiring operator performed critical steps (e.g., scrubbing with a brush or rinsing with a hose)
44. Maximum allowable
The maximum amount of carryover from one product to the next that will not produce a therapeutic dose, corrected for a safety factor (e.g., 1/1000)
45. Minimum
pharmacological dose
The minimum dose required to elicit a response in vitro or in vivo
46. Minimum therapeutic
The minimum dose that will produce a pharmacological response as derived by medical criteria
47. Minor equipment Ancillary equipment (e.g., dispensing containers, utensils, scoops) associated with a drug product manufacturing process
48. Peptizing To bring into colloidal solution, esp. proteins
49. Placebo Inert material or formulation
50. Placebo scrubbing (or solid washing) Use of an inert material to mechanically displace and dilute residuals
51. Process validation Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes
52. Product family A group of closely formulated products with the same active ingredient(s)
53. Prospective Establishing documented evidence that a system validation does what it is supposed to do, based on information generated before actual implementation of the process
54. Protocol A document with agreed upon set of standards and tests
55. Prototyping Use of a representative drug product and/or piece of equipment to demonstrate a cleaning procedure can achieve adequate levels of cleanliness for similar product and/or equipment families
56. pyrogen A material which elicits a pyrogenic response (fever)
57. Rinse (aqueous/ nonaqueous) To cleanse or treat an equipment as part of a cleaning procedure
58. Safety factor A predetermined value (e.g., 1/1000) used to minimize the uncertainty of a calculated limit
59. Sanitize To make physically clean and to remove and destroy, to the maximum degree that is practical, agents injurious to health
60. Semi-automated A system controlled partly by mechanical/electronic devices, but requiring some manual intervention
61. Serial cleaning Cleaning performed in the midst of a production campaign; serial cleaning is usually less intensive than the procedure used between different products
62. Swab An absorptive device used to remove a sample from a surface
63. Therapeutic dose An amount of drug that will produce a pharmacological response
64. Toxic dose The minimum dose required to produce a harmful, poisonous effect
65. Visually clean Absence of visible contaminants
66. Worst case The highest or lowest value of a given control parameter, maximum system load, or maximum or minimum environmental conditions actually evaluated in a validation exercise

Reference: PDA Technical Report No. 29

Production & purification of drinking-water as per WHO

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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