Clean Rooms in Pharmaceutical Operations

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.



Applicable Standards:

US Food and Drug Administration (FDA)
◦ 21 CFR Part 210
◦ 21 CFR Part 211
◦ 21 CFR Part 11
◦ Pharmacopeias of US, Europe, Japan (USP, EP, JP)
◦ Various GMPs from European countries
◦ EudraLex Volume 4, GMP Guidelines Part 1, Basic Requirements for Medicinal products
◦ Annex 1 Manufacture of Sterile products
◦ Annex 5 Manufacture of Immunological Veterinary Medicinal Products
◦ Annex 9 Manufacture of Liquids, Creams and Ointments
◦ Annex 10 Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation
◦ Annex 11 Computerized Systems
◦ Annex 15 Qualification and Validation
◦ Other source of guidance:
◦ International Society of Pharmaceutical Engineers (ISPE), Baseline Guides
◦ ISO 14644 (Specifically ISO 14644-1:2015)

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