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Pharmaceuticals/Dedicated facility


QUESTION: Dear Anisfeld,

While developing the layout for sterile and topical facility we face a question whether Steroid and Non-Steroid lines should be in different facility or it can be within the same facility with different lines (dispensing to filling) having common changerooms. Could you please clarify?


ANSWER: For most markets that you are exporting to corticosteroids can be made in the same facility; however sex hormones cannot. Check with your regulatory folks about country specific requirements.

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QUESTION: Dear Anisfeld,

We are now planning to setup an Ophthalmic mfg facility having both steroid and non-steroid products. Do we need to make a dedicated/ separate line or a common line for both type of products? Please give answer considering WHO/EU GMP guideline.


ANSWER: Dear Zafar:

As long as your steroids are not sex hormones, and as long as local regulations do not prohibit it, then you do not need separate production lines. What you do need is a very robust cleaning validation program.

Incidentally I will be in Dhaka all next week and if you'd like to chat about your plans I'd be happy to meet for a coffee. I am staying at the Westin Hotel - where you can reach me, or leave a message.

With best Regards,
Michael Anisfeld

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QUESTION: Dear Anisfeld

We are excited to hear that you will be in Dhaka next week and eagerly waiting to meet you, my Group Director will be with me. Please inform your itinerary in Dhaka.

My company is planning to setup a EU GMP certified manufacturing facility for Oncology, Hormone and Ophthalmic products. A Spanish engineering company is appointed for the job. We need support/ opinion to clarify various GMP related issues from an expert. I request you to send your profile so that I can have a discussion with my top management.  

Zafar Ahmed Tarique
Vice President, Plant
Orion Pharma Ltd.
Cell: +8801755545425
e- mail:  

Dear Zafar:

As I mentioned I arrive in Bangladesh on May 19 early morning, and leave on May 31. I am staying at the Westin hotel, Dhaka. I am free most evenings and would be happy to meet you and your Orion colleagues on any evening after May 21.

To send you a profile of our services, I need your e-mail address, which was omitted above. For further communications, please can you e-mail me direct at I will then immediately send you a profile of our services.

Looking forward to meeting,
Best Regards,
Michael Anisfeld  


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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