The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.
PDA

View Full Version : Pharmaceuticals (21 CFR parts 210 & 211)

  1. Tracebility requirements in Pharma vs Medical Devices - Nonconformance issue
  2. SUPAC (Scale Up and Post Approval Changes) guidelines for pharmaceuticals
  3. Comparison of EU and US GMPs - Differences applying CFR211 or the EU GMPs
  4. IS there such a thing as FDA "Good Distribution Practices"
  5. ISO 15378:2006, Primary packaging materials for medicinal products
  6. Auditing Pharmaceutical Toll Manufacturers
  7. Key Performance Indicators in a pharmaceutical company
  8. Pharmaceutical Company Quality Manual
  9. Permanent Inspection Readiness for a pharma manufacturing firm
  10. Transitioning from ISO 9001 to CFR - Recently transferred to a Pharma company
  11. ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
  12. The most current version or draft of the Q10 - Pharmaceutical Quality Systems
  13. What is the link between FDA and US Pharmacopeia?
  14. Questions about cGMP in a pharmaceutical company in China
  15. FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211
  16. GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US)
  17. Liability for Packaged Drug products Sold Indirectly in the International Market.
  18. Part 11 Requirements - Medical Devices vs. Pharmaceuticals
  19. Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations
  20. Can a prescription type material be used as a predicate for an OTC material?
  21. Calculation for Similarity and Differences in dissolution profile (F1&F2 Values)
  22. 21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
  23. 21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
  24. USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process
  25. Rework vs. Reprocess - Definitions - Pharmaceuticals
  26. Drug product physical properties stability studies - which properties to test?
  27. FDA - "Net Quantity of Contents" - Manufacturing filling process
  28. Sterility (bacteriostasis/fungistasis) Testing by Membrane Filtration validation
  29. Is Medical Grade Gas always a drug?
  30. Any one know about FDA's GMP, 21 CFR Part 111
  31. Change Control for FDA industry - Drug Manufacturer
  32. Facility qualification - API (Active Pharmaceutical Ingredient) industry
  33. ANDA (Abbreviated New Drug Application) Filing - Ophthalmic Solution
  34. Drug Registration in European Union - European Medicines Agency (EMEA)
  35. Barcode Format Question - Variable vs. Fixed Segment Length
  36. Clinical trials - Generic "parent" procedure vs. study-specific "child" versions
  37. Relationship between Blend Uniformity and Content Uniformity
  38. Roles and Responsibilities for new Documentation and Compliance team
  39. Guideline for streamlined batch record review process - cGMP compliance - Needed
  40. Environment Monitoring programme for pharmaceutical industry
  41. CDSCO Guidelines for Port Officers on Imp and Export of Drugs & Cosmetics
  42. Teva recalls drug following Jackson death probe
  43. Facts and Myths about Generic Drugs
  44. GMP question - New pharma/drug manufacturing facility certification timeline/sequence
  45. Compatibilty between two substances (Amidopyrin and Methampyron)
  46. FDA approves Influenza A (H1N1) 2009 vaccines
  47. Deviation Record Example for a Pharma Company
  48. ISO 13485 and ISO 14971 - Medical Devices and Related Forums