Table 2. Requirements of the European Pharmacopoeia (monographs “Allergen products” (1063), “Animal epithelia and outgrowths for allergen products” (2621) and “Mites for allergen products” (2625)) compared to requirements of current good manufacturing practice regulations according to 21 CFR 680.1(b); information in these certificates on starting material batches (from Stallergenes Greer 2021 – 2024 with reference to 21 CFR 680.1(b)) and Allergon 2020 – 2022 with reference to European Pharmacopoeia).

Ph. Eur. requirements	21 CFR 680.1(b)	Allergon – storage mites	Stallergenes Greer – storage mites	Stallergenes Greer – animal epithelia	Stallergenes Greer – cereal grain
Obtained from qualified suppliers	Listing of source materials and suppliers: Each licensed manufacturer shall initially list with the Director, Center for Biologics Evaluation and Research, the name and address of each of the manufacturer’s source material suppliers. The listing shall identify each source material obtained from each source material supplier. The licensed manufacturers shall update the listing annually to include new source material suppliers or to delete those no longer supplying source Materials. Nonlicensed source material suppliers are exempt from drug registration.	√	√	√	√
Defined, where possible, by their origin, nature, method of collection, or production and pretreatment	Only specifically identified allergenic source materials that contain no more than a total of 1.0 percent of detectable foreign materials shall be used in the manufacture of Allergenic Products.	√	√	√	√
Establishment of control methods and acceptance criteria relating to identity and purity	n.s.	√	n.s.	n.s.	n.s.
Storage under controlled conditions, justified by stability data; ensuring a consistent composition from batch to batch	n.s.	√	√	√	√
When applicable, pesticides, heavy metals, and residual solvents are limited	n.s.	n.s.	n.s.	n.s.	n.s.
Microbial contamination should be monitored	n.s.	n.s.	n.s.	n.s.	n.s.
For foods: Suitable quality for human consumption, origin, and the processing stage is stated	Mammals and birds, subject to inspection by the U.S. Department of Agriculture at the time of slaughter and found suitable as food, may be used as a source material, and the requirements of paragraph (b)(3) (i) through (iv) of this section do not apply in such a case. Reporting obligations and obligations to store dead animals remain unchanged.	n.a.	n.a.	n.a.	n.s.
For mites/epithelia: Limit on foreign matter	No more than a total of 1.0 percent of detectable foreign materials Not applicable for molds and animals described	√	(√) Not specified, but follows from 21 CFR 680.1(b)	n.s.	n.a.
For mites/epithelia: Water/loss on drying (for dried material)	n.s.	√	n.s.	n.s.	n.a.
For mites: Purity (when the source material is a purified fraction of the mite culture)	n.s.	√	n.s.	n.a.	n.a.
For mites Method of mite cultivation is described, critical parameters are controlled and monitored	n.s.	√	n.s.	n.a.	n.a.
For mites: Unless otherwise justified, the culture medium is selected to avoid the presence of materials with potential allergenicity	n.s.	(√) Free of mold No indication of the medium	n.s.	n.a.	n.a.
For mites: Inactivation by methods, which are qualified capable to maintain allergenic properties	n.s.	√ Gamma rays	√ Freezing	n.a.	n.a.
For epithelia: Healthy animals, confirmed by a responsible veterinarian or another competent person, skin visibly clean and intact, and the animal have not been recently treated with preparations for cutaneous application	Maintenance by competent personnel in facilities or designated areas that will ensure adequate care, only animals in good health and free from detectable skin diseases shall be used as a source material for Allergenic Products, determination of good health shall be made by a licensed veterinarian or a competent individual under the supervision and instruction of a licensed veterinarian	n.a.	n.a.	√	n.a.
For epithelia: Exact species and/or variety is stated	Stated above: Only specifically identified allergenic source materials shall be used in the manufacture of Allergenic Products	n.a.	n.a.	√	n.a.
For epithelia: Collection without injuring the skin, prevention of cross-contamination, source material collection is specified	Pelts, feathers, hairs and danders shall be collected in a manner that will minimize contamination of the source material	n.a.	n.a.	√	n.a.
n.s.	For mammals/birds: Immunization against tetanus	n.a.	n.a.	(√) Not specified, but implicit in stated compliance to 21 CFR 680.1(b)	n.a.
n.s.	For mammals/birds: Reporting of cases of actual or suspected infection with foot and mouth disease, glanders, tetanus, anthrax, gas gangrene, equine infectious anemia, equine encephalomyelitis, or any of the pock diseases	n.a.	n.a.	(√) Not specified, but implicit in stated compliance to 21 CFR 680.1(b)	n.a.
n.s.	For mammals/birds: Dead animals may be used as source material in the manufacture of Allergenic Products, provided that the carcasses shall be frozen or kept cold until the allergen can be collected, or shall be stored under other acceptable conditions so that the postmortal decomposition processes do not adversely affect the allergen; when alive, the animal met the applicable requirements, previously mentioned	n.a.	n.a.	(√) Not specified, but implicit in stated compliance to 21 CFR 680.1(b)	n.a.

n.s. = not specified; n.a. = not applicable; Ph. Eur = European Pharmacopoeia.