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Sterile Manufacturing of Parenteral Products (US Food and Drug Administration)

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4. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, read it .
5. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, read it .
6. Code of Federal Regulations Title 21 Part 211 (Specifically, 211.113, 211.42, 211.67, 211.63, 211.167, 211.165, 211.192, 211.194, 211.22, 211.25, 211.28, 211.65, 211.103, 211.84, 211.46, 211.166, 211.13), read it .
7. Code of Federal Regulations Title 21 Part 820 (Specifically, 820.30), read it .
8. Code of Federal Regulations Title 21 Part 606, read it .
9. Code of Federal Regulations Title 21 Part 177, read it .
10. Guide to Inspections Validation of Cleaning Processes, read it .
11. Compliance Program Guidance Manual, Sterile Drug Process Inspections Program, Chapter 56-Drug Quality Assurance, read it .
12. Process Validation: General Principles and Practice, read it .
13. Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, read it .
14. Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4, read it .
15. Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA, read it .
16. Classification of Products as Drugs and Devices and Additional Product Classification Issues, read it .
17. Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, read it .
18. How to Write a Request for Designation (RFD), read it .
19. Proposed Rule: Current Good Manufacturing Practice Requirements for Combination Products (74 Fed. Reg. 48,423), read it .
20. New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products, read it .
21. Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), read it .
22. Minimal Manipulation of Structural Tissue (Jurisdictional Update), read it .
23. Early Development Considerations for Innovative Combination Products, read it .
24. Application User Fees for Combination Products, read it .
25. Current Good Manufacturing Practice for Combination Products (Draft Guidance), read it .
26. Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product, read it .
27. Guidance for Industry: Manufacturing, Processing, or Holding APIs, read it .
28. ORA: ORA-Lab.5.3; Facilities and Environmental Conditions, read it .

Please find below reference links (click on the text) that you may find informative.

  • -Lists information for the:

Information related to use of bulk drug substances in compounding under section 503B.

  • (Comment Period ends on 5/24/2021-Docket # ; 86 FR 15673)

For your awareness, the Small Business and Industry Assistance (SBIA) will be holding a conference on Generic Drugs on April 28-29, 2021. Please reference the SBIA website for event information and future offerings.

If you were unable to attend the listening session, but were interested in connecting with OCQC, please feel free to connect with me following the session date.

We hope you all will be able to join us again for the Annual Listening Session on June 15, 1:00 pm - 5:00 pm. If you have further comments or questions that you would like to raise, please send them to:

International Conference for Harmonization

29. ICH Q10, Pharmaceutical Quality System, read it .
30. ICH Q8, Pharmaceutical Development, read it .
31. ICH Q9, Quality Risk Management, read it .

Medicines and Healthcare Products Regulatory Agency

32. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 - the 'Orange Guide', read it .

European Union

33. EudraLex - Volume 4 Good manufacturing practice, Annex 1 (specifically, Annex 1.4, 1.42, 1.55, 1.3, 1.36, 1.54, 1.55, 1.61, 1.56), read it .
34. EudraLex - Volume 4 Good manufacturing practice, Annex 5.37, read it .

United States Pharmacopeia

35. USP <1116> Microbiological control and monitoring of aseptic processing environments.
36. USP 36-NF 31, read it here.
37. USP <71>, Sterility Tests.
38. USP <87>, Biological Reactivity Test, In Vitro.
39. USP <88>, Biological Reactivity Test, In Vivo.

International Body of Knowledge

40. Good Manufacturing Practices for Sterile Pharmaceutical Products, read it .

Parenteral Drug Association

41. I. Kaesler, G. Haake, H. Hennig, A. Rosenhagen, T. H. Meltzer, and M. W. Jornitz, "The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters鈥擯art I," PDA Journal of Pharmaceutical Science and Technology65, 92-99, March/April 2011, read it .
42. G. Haake, I. Kaesler-Neumann, H. Hennig, T. H. Meltzer, and M. W. Jornitz, "The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters. Part II. The Comparison of Hydrogenophaga pseudoflava ATTC 33668 and Curvibacter sp. ATCC 700892 by Microbial Challenge Tests with Membrane Filters," PDA Journal of Pharmaceutical Science and Technology 66, 346-353, July/Aug 2012, read it .
43. "Validation of Moist Heat Sterilization Processes," PDA Technical Report 1, read it here.
44. "Moist Heat Sterilizer Systems Design, Commissioning, Operation, Qualification, and Maintenance," PDA Technical Report 48, read it .
45. "Fundamentals of an Environmental Monitoring Program," PDA Technical Report 13, read it .
46. "Sterilizing Filtration of Liquids," PDA Technical Report 26, read it .
47. K. Mignot, 鈥淜ey Factors for Validating a Disposable System鈥� PDA Letter, October 2013.
48. I. Kaesler, G. Haake, H. Hennig, A. Rosenhagen, T.H. Meltzer, M.W. Jornitz, 鈥淭he Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters-Part I & Part II鈥� PDA Journal of Pharmaceutical Technology65 (2), 92鈥�9, 2011 and 66 (4), 346鈥�53, 2012, read them and .

Media and Other Sources

49, A. Bhatia, 鈥淗VAC Design for Cleanroom Facilities鈥� cedengineering.com, read it .
50. J. Boehm, 鈥淪ingle-Use Connections Enable Advancements in Aseptic Processing," BioProcess International 8 (4), 32鈥�35, April 2010, read it .
51. M.A. Petrich, 鈥淒esign and deployment Strategy for Single-Use Components and Assemblies,鈥� American Pharmaceutical Review, December 2013, read it .
52. M. Trotter, 鈥淎doption of Single-Use Disposable Technology in Biopharma Industries 鈥� Manufacturing, Economic and regulatory Issues to Consider,鈥� American Pharmaceutical Review, March 2012, read it .
53. J. Boehm, "Improving Flexibility and Saving Money for Biopharmaceutical Manufacturers,鈥� BioProcess International, April 2010.
54. E. Jenness and V. Gupta, 鈥淚mplementing a Single-Use Solution for Fill-Finish Manufacturing Operations,鈥� BioProcess International, May 2011, read it .
55. J.D. Vogel, 鈥淭he Maturation of Single-Use Applications,鈥� BioProcess International10 (5), 10鈥�18, May 2012, read it .
56. Collected pieces from Rizwan Sharnez, read them .
57. Collected pieces from the 听and the听, "The Aseptic Core," read them .