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  1. using System;
  2. using System.Text.RegularExpressions;
  3. public class Test
  4. {
  5. 	public static void Main()
  6. 	{
  7. 		string pattern = @"^ \d+[\r\n](?:(?!\s+\d+[\r\n]).*[\r\n])*3\.2\.P\.4\.4\.\sJustification\s+of\s+Specifications";
  8.         string input = @" 26
  9. Data related to the point SP-WFI-21-Room process fluids  
  10. Sampling Date:16/04/2007 
  11.  28
  12. Data related to pint SP-WFI-21-Room process fluids  
  13. Sampling Date: 20/04/2007 
  14. TEST SPECIFICATIONS RESULTS 
  15. T.O.C. ≤ 500 ppb 6ppb 
  16. Conductivity at 25°C ≤ 1.3 μS.cm-1 1.1 μS.cm-1 
  17. Data related to the point of use UP-WFI-07 
  18. Sampling Date: 20/04/2007 
  19. TEST SPECIFICATIONS RESULTS 
  20. Appearance Clear and colourless liquid Conforms 
  21. pH 5.0 – 7.0 6.20 
  22. Oxidable substances Conforms Conforms 
  23. Conductivity at 25°C ≤ 1.3 μS.cm-1 1.1 μS.cm-1 
  24. 0 microrg./100ml 
  25. Reference guidelines 
  26. − 3AQ11A: Specifications and Control Tests on the Finished Product - EUDRALEX Volume 3A 
  27. − Topic Q6A, Step 4 Note for Guidance Specifications: Test procedures and Acceptance Criteria for New 
  28. Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/96 - Adopted Nov. 99) 
  29.  29
  30. 3.2.P.4.2 Analytical Procedures 
  31. All the analytical procedures related to the control of excipients are those described in the 
  32. corresponding Ph. Eur. monographs current edition (refer to 3.2.P.4.1). 
  33. Reference guidelines 
  34. − Topic Q2A, Step 5  Note for Guidance on Validation of Analytical Methods: Definitions and Terminology 
  35. (CPMP/ICH/381/95 - adopted Nov. 94) 
  36. − 3AQ14A: Validation of Analytical Procedures: Definition and Terminology - EUDRALEX Volume 3A 
  37. − 3AQ13A: Validation of Analytical Procedures: Methodology - EUDRALEX Volume 3A 
  38. − Topic Q6A, Step 4 Note for Guidance Specifications: Test procedures and Acceptance Criteria for New 
  39. Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/96 - Adopted Nov. 99) 
  40. 3.2.P.4.3 Validation of Analytical Procedures 
  41. All the analytical procedures proposed to control the excipients are those reported in Ph. Eur. 
  42. monographs current edition and no variation has been introduced; each method is validated 
  43. concerning specificity and linearity, in order to grant suitability of the instruments used. 
  44. Reference guidelines: 
  45. − Topic Q2A, Step 5  Note for Guidance on Validation of Analytical Methods: Definitions and Terminology                     
  46. (CPMP/ICH/381/95 - adopted Nov. 94) 
  47. − 3AQ14A: Validation of Analytical Procedures: Definition and Terminology - EUDRALEX Volume 3A 
  48. − 3AQ13A: Validation of Analytical Procedures: Methodology - EUDRALEX Volume 3A 
  49. 3.2.P.4.4. Justification of Specifications ";
  50.         RegexOptions options = RegexOptions.Multiline;
  51.  
  52.         foreach (Match m in Regex.Matches(input, pattern, options))
  53.         {
  54.             Console.WriteLine(m.Value);
  55.         }
  56. 	}
  57. }
Success #stdin #stdout 0.04s 134592KB
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 29
3.2.P.4.2 Analytical Procedures 
All the analytical procedures related to the control of excipients are those described in the 
corresponding Ph. Eur. monographs current edition (refer to 3.2.P.4.1). 
Reference guidelines 
− Topic Q2A, Step 5  Note for Guidance on Validation of Analytical Methods: Definitions and Terminology 
(CPMP/ICH/381/95 - adopted Nov. 94) 
− 3AQ14A: Validation of Analytical Procedures: Definition and Terminology - EUDRALEX Volume 3A 
− 3AQ13A: Validation of Analytical Procedures: Methodology - EUDRALEX Volume 3A 
− Topic Q6A, Step 4 Note for Guidance Specifications: Test procedures and Acceptance Criteria for New 
Drug Substances and New Drug Products: Chemical Substances (CPMP/ICH/367/96 - Adopted Nov. 99) 
3.2.P.4.3 Validation of Analytical Procedures 
All the analytical procedures proposed to control the excipients are those reported in Ph. Eur. 
monographs current edition and no variation has been introduced; each method is validated 
concerning specificity and linearity, in order to grant suitability of the instruments used. 
Reference guidelines: 
− Topic Q2A, Step 5  Note for Guidance on Validation of Analytical Methods: Definitions and Terminology                     
(CPMP/ICH/381/95 - adopted Nov. 94) 
− 3AQ14A: Validation of Analytical Procedures: Definition and Terminology - EUDRALEX Volume 3A 
− 3AQ13A: Validation of Analytical Procedures: Methodology - EUDRALEX Volume 3A 
3.2.P.4.4. Justification of Specifications
https://ideone.com/wBY5E1
language:
C# (gmcs 5.20.1)
created:
6 years ago
visibility:
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