𝗠𝗼𝘀𝘁 𝗰𝗵𝗮𝗻𝗴𝗲 𝗰𝗼𝗻𝘁𝗿𝗼𝗹𝘀 𝗱𝗼𝗻’𝘁 𝗳𝗮𝗶𝗹 𝗱𝘂𝗿𝗶𝗻𝗴 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻, 𝘁𝗵𝗲𝘆 𝗳𝗮𝗶𝗹 𝗱𝘂𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗽𝗵𝗮𝘀𝗲. An incomplete impact assessment can lead to unnecessary delays, compliance risks, rework,
Contributed by SME: Diane K Gates, President, CenPharma 503B outsourcing facilities sit at a difficult intersection. They operate with the pace and variability of a
Pharmacy 503B Outsourcing refers to a specific type of pharmaceutical outsourcing facility regulated under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).
𝙍𝙚𝙖𝙘𝙩𝙞𝙫𝙚 𝙧𝙚𝙢𝙚𝙙𝙞𝙖𝙩𝙞𝙤𝙣 𝙞𝙨 𝙣𝙤 𝙡𝙤𝙣𝙜𝙚𝙧 𝙚𝙣𝙤𝙪𝙜𝙝. Regulators are no longer evaluating how quickly companies fix problems. They are evaluating whether systems are designed to prevent
Most growing life science companies make the same quality mistake: They build a quality organization for where they hope to be, not where they are today. The
Recently, our team completed a project under budget, leaving funds remaining on the original purchase order. While we’re proud of the quality of the work
𝗠𝗮𝗻𝘆 𝟱𝟬𝟯𝗕 𝘀𝘁𝗮𝗿𝘁𝘂𝗽𝘀 𝗯𝘂𝗶𝗹𝗱 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 𝘁𝗶𝗺𝗲𝗹𝗶𝗻𝗲𝘀 𝗮𝗿𝗼𝘂𝗻𝗱 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘀𝘁𝗿𝘂𝗰𝘁𝗶𝗼𝗻, 𝗲𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁 𝗶𝗻𝘀𝘁𝗮𝗹𝗹𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀. Then reality sets in. The facility is operational. The equipment is
If you’ve spent time in pharmaceutical manufacturing or quality over the last year, you’ve probably heard someone say: “CSV is going away.” Not quite. But
For years, most pharmaceutical companies have treated inspection readiness like a finish line. You build the facility. You qualify the equipment. You prepare the documentation.
Is your internal QA team becoming overwhelmed by the document review for a new facility project? When commissioning and qualification are outsourced but quality oversight
