💁🏼♂📣Pharmaceutical Manufacturing Case Study, Registering a New MIA for a client who previously failed 🌟🤷
💁This short case study provides an overview of the status of the client when I was asked to support them and the process followed to gain approval of their #manufacturing site with the MHRA.
💁🏼♂The issue with a new manufacturing site is often a lack of funding, or should I say adequate funding. The person with the funds wants a licence as they have seen a gap in the market. ✅💥
💁There are many consultants offering to help with new site registrations using their "own" SOPs. Unfortunately manufacturing is not a one size fits all type of industry. Imagine you want to manufacture and fill a liquid into a bottle, the consultant says I can get you a licence but that person has only ever operated from a virtual company supplying tablets.👈🌟
💁🏼♂They use their existing SOPs for tablet supply remotely and spend minimal time at site and hand over the SOPs.✅💥
💁At the inspection they can talk about the SOPs but not your business, you can talk about your business but not #GMP good manufacturing practices.💥
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💁🏼♂Doomed to fail unfortunately.🤷
💁🏼♂With over 37 years experience in Pharmaceutical manufacturing and supply I will never supply you with "my own" SOPs we will create the right SOPs for your business.✅🌎
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18 сен 2024
