USP <787>: Application and Scope
- Specifically for protein-based therapeutics (not all forms of injectables)
- Analysis of final dose and packaging
- Smaller test product volumes
- Smaller test aliquots
- Defines “inherent” form of particulate matter
- Describes prep and test methods
- Defines maximum particle burden limits
Although USP <787> focuses exclusively on protein-based formulations, there are a number of similarities between USP <787> and USP <788> (Particulate Matter in Injections) including:
- Primary method: Light Obscuration1
- Secondary method: Light Microscopy
- Minimum number of aliquots = 4
- Particle size thresholds ≥ 10 & ≥ 25 µm
- Particle limits:
- SVI: 6,000 & 600 per container
- LVI (>100 mL): 25 & 3 per mL*
*Larger test volumes must also pass a container test. No more than 6,000 counts at 10 microns and no more than 600 counts at 25 microns.
1 Should the primary method not be applicable (e.g., preparations with reduced clarity or increased viscosity), microscopic particle testing should be carried out.
Helping researchers and labs maintain compliance with standards
-
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>