BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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Page 35 of 38 July 2021 BioPharm International eBook 35 Prioritizing Cleaning Validation As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. K eeping pharmaceutical facilities clean and germ free seems an obvious prerequisite for any company that manufactures medicines. However, regulatory citations suggest that pharmaceutical manufacturers and contract manufacturing and development organizations (CDMOs) may take cleaning and cleaning validation for granted. A n Apr i l 2 021 For m 483 issued by F DA to t he M a r y l a n d-b a s e d C DMO, E m e r g e nt Bio s olut ion s , which is under contract to Johnson & Johnson ( J&J) and AstraZeneca to manufacture their COVID-19 vaccines, showed how deeply rooted this problem may be (1). J&J and AstraZeneca use very different manufacturing processes, but both involve the use of viral vectors. FDA inspectors found fundamental deviations from good manufact uring practices (GMPs) at the facilit y. Among the observations noted were failure to maintain clean and sanitary conditions; lack of written procedures for cleaning and decontamination of the vessels used to trans- port and store materials at the site; and no formal require- ments to clean and sanitize these vessels after each use. In addition, no tests were conducted to determine how long viruses used in a client's production process remained viable on equipment surfaces in one area within the facility. CASTING THE FIRST STONE? If these omissions seem basic, it might be helpful to remember t hat in pre-pa ndemic 2 019, t he last f u l l yea r when F DA per formed routine site inspections, rough ly 6 0 % of F DA 4 83 reg u l ator y obser v at ions AGNES SHANLEY is former senior editor at BioPharm International. AGNES SHANLEY bankrx - Biopharmaceutical Analysis Cleaning Validation

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