Resources
GMP Standard Operating Procedures
Sterile Manufacturing of Parenteral Products (US Food and Drug Administration)
1. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf
2. http://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf
3. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/current-issues-in-aseptic-processing.pdf?sfvrsn=6
4. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, read it here.
5. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, read it here.
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
here.
7. Code of Federal Regulations Title 21 Part 820 (Specifically, 820.30), read it here.
8. Code of Federal Regulations Title 21 Part 606, read it here.
9. Code of Federal Regulations Title 21 Part 177, read it here.
10. Guide to Inspections Validation of Cleaning Processes, read it here.
11. Compliance Program Guidance Manual, Sterile Drug Process Inspections Program,
Chapter 56-Drug Quality Assurance, read it here.
12. Process Validation: General Principles and Practice, read it here.
13. Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with
Drugs and Biological Products, read it here.
14. Glass Syringes for Delivering Drug and Biological Products: Technical Information
to Supplement International Organization for Standardization (ISO) Standard 11040-4, read it here.
15. Submissions for Postapproval Modifications to a Combination Product Approved Under
a BLA, NDA, or PMA, read it here.
16. Classification of Products as Drugs and Devices and Additional Product Classification
Issues, read it here.
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 here.
18. How to Write a Request for Designation (RFD), read it here.
19. Proposed Rule: Current Good Manufacturing Practice Requirements for Combination Products
(74 Fed. Reg. 48,423), read it here.
20. New Contrast Imaging Indication Considerations for Devices and Approved Drug and
Biological Products, read it here.
21. Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps), read it here.
22. Minimal Manipulation of Structural Tissue (Jurisdictional Update), read it here.
23. Early Development Considerations for Innovative Combination Products, read it here.
24. Application User Fees for Combination Products, read it here.
25. Current Good Manufacturing Practice for Combination Products (Draft Guidance), read it here.
26. Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket
Review of a Combination Product, read it here.
27. Guidance for Industry: Manufacturing, Processing, or Holding APIs, read it here.
28. ORA: ORA-Lab.5.3; Facilities and Environmental Conditions, read it here.
Please find below reference links (click on the text) that you may find informative.
- Human Drug Compounding
- Compounding Risk Alerts | FDA
- Compounding Laws and Policies
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry (draft guidance)
- Compounding Quality Center of Excellence Training Programs -Lists information for the:
Information related to use of bulk drug substances in compounding under section 503B.
- Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act
- Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Revised Request for Nominations (79 Federal Register Notice (FRN) 37750, [July 2, 2014])
- Interim Policy on Compounding Using Bulk Drug Substances
- Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Act (Comment Period ends on 5/24/2021-Docket # FDA-2018-N-3240; 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:
- compounding@fda.hhs.gov for general compounding program inquires
- CompoundingQualityCoE@fda.hhs.gov for Compounding Quality Center of Excellence inquires
International Conference for Harmonization
29. ICH Q10, Pharmaceutical Quality System, read it here.
30. ICH Q8, Pharmaceutical Development, read it here.
31. ICH Q9, Quality Risk Management, read it here.
Medicines and Healthcare Products Regulatory Agency
32. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 - the 'Orange Guide', read it here.
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 here.
34. EudraLex - Volume 4 Good manufacturing practice, Annex 5.37, read it here.
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 here.
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—Part I," PDA Journal of Pharmaceutical Science and Technology65, 92-99, March/April 2011, read it here.
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 here.
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 here.
45. "Fundamentals of an Environmental Monitoring Program," PDA Technical Report 13, read it here.
46. "Sterilizing Filtration of Liquids," PDA Technical Report 26, read it here.
47. K. Mignot, “Key Factors for Validating a Disposable System” PDA Letter, October 2013.
48. I. Kaesler, G. Haake, H. Hennig, A. Rosenhagen, T.H. Meltzer, M.W. Jornitz, “The
Importance of Accurate Microorganism Identification in Microbial Challenge Tests of
Membrane Filters-Part I & Part II” PDA Journal of Pharmaceutical Technology65 (2), 92–9, 2011 and 66 (4), 346–53, 2012, read them here and here.
Media and Other Sources
49, A. Bhatia, “HVAC Design for Cleanroom Facilities” cedengineering.com, read it
here.
50. J. Boehm, “Single-Use Connections Enable Advancements in Aseptic Processing,"
BioProcess International 8 (4), 32–35, April 2010, read it here.
51. M.A. Petrich, “Design and deployment Strategy for Single-Use Components and Assemblies,”
American Pharmaceutical Review, December 2013, read it here.
52. M. Trotter, “Adoption of Single-Use Disposable Technology in Biopharma Industries
– Manufacturing, Economic and regulatory Issues to Consider,” American Pharmaceutical Review, March 2012, read it here.
53. J. Boehm, "Improving Flexibility and Saving Money for Biopharmaceutical Manufacturers,”
BioProcess International, April 2010.
54. E. Jenness and V. Gupta, “Implementing a Single-Use Solution for Fill-Finish Manufacturing
Operations,” BioProcess International, May 2011, read it here.
55. J.D. Vogel, “The Maturation of Single-Use Applications,” BioProcess International10 (5), 10–18, May 2012, read it here.
56. Collected pieces from Rizwan Sharnez, read them here.
57. Collected pieces from the Journal of Validation Technology and the Journal of GXP Compliance, "The Aseptic Core," read them here.