USP <788>, <787> and EP2.9.19
Defining allowable limits of sub-visible particulates in parenteral formulations
Chapters <788> and <787> of the United States Pharmacopeia (USP), Particulate Matter in Injections, and chapter 2.9.19 of the European Pharmacopoeia apply to most small- and large-volume parenteral products, particularly ready-to-use solutions for intramuscular, subcutaneous or intravenous (IV) injection.
USP defines particulate matter as mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. Further, it provides 2 tests for detecting subvisible particulates—light obscuration technology and microscopic assay. USP<788>, <787> and EP2.9.19 are harmonized and state a preference for using the light obscuration counter, deferring only to the microscopic method when the light obscuration instrument cannot be used for some reason. These instruments are generally accepted for use in testing:
- Small-volume parenteral infusions/injectables (ampules and vials)
- Large-volume parenteral infusions/injectables (IV solutions)
Although light obscuration technology is generally the preferred testing method, it may be necessary to test some formulations using light obscuration and a microscopic particle count test to confirm compliance with applicable requirements.
Note that USP <788> does not apply for:
- Radiopharmaceutical preparations
- Parenterals for use only as irrigating solutions
- Parenterals requiring use of a filter prior to administration (provided scientific data justifies an exemption)
Helpful Links
-
Industry Standards
- USP<643>
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding FDA ALCOA Guidance
- European Pharmacopoeia EP 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ICH Q2
- ISO 21501
- ISO Regulations
-
IVD-Regulation (IVDR)
- IVDR compliant instruments*
- IVDR compliant software*
- IVDR compliant reagents
- E-book
- Future proofing your flow cytometry panel under IVDR
- In-house IVD FCM panel or not: it depends
- Building IVDR compliant panels for haematological disorders
- Impact of the new EU IVD-Regulation on the daily life of the clinical Flow cytometry laboratory webinar
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Meet the Expert — Maurizio Suppo, PhD
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
- IVD-R: Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <788>, <787> and EP2.9.19
- USP <790>
- ISO 11171 Standard
-
ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
- Particle Counters Designed to Support ISO 14644-1 and ISO 21501-4 Requirements
- 2015 Published Standards for ISO 14644
- ISO 14644-1 Classification of Air Cleanliness by Particle Concentration
- ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
- Particle Counting: Terms and Formulas
- USP <787>