Bioequivalence and Bioavailability Forum

Recalled Paracetamol, a question for CMC gurus [Off Topic]

posted by nobody – 2019-06-19 19:40 (1446 d 06:31 ago) – Posting: # 20350
Views: 5,059

...if you don't want any products "produced" in China or India then start growing your own Herba Chamomill. in your backyard, otherwise you're lost...

This legislation is imho 100% triggered by the manufacturers (generic+originators) to "improve economic conditions world-wide and trigger important investments in developing countries" (or what it would read like in the investors brochure).

___

PS:

MedWatch - The FDA Safety Information and Adverse Event Reporting Program
A MedWatch Safety Alert was just added to the FDA Recalls web page.

TOPIC: All Unexpired Sterile Drug Product Lots by Premier Pharmacy Labs: Recall - Due to Lack of Sterility Assurance

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: The unexpired sterile drug product lots are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. ....

Just the latest of these emails dropping in here frequently. It doesn'T matter where your medicine is fu** up eeehm produced. It'S the same sh** everywhere.

From their homepage:

"
STERILE COMPOUNDING PHARMACY

Premier Pharmacy Labs is committed to sterile compounding excellence. We were one of the first pharmacies in the United States to register as a 503B outsourcing facility (see FDA 503B). Premier has increased its resources and revenues towards expanding the sterile operations of our business. Adhering to GMP manufacturing standards is something new to all compounding pharmacies across the US and Premier is pushing to stay ahead of the mark with continued investment and innovation.
"

Complete thread:

• Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-18 17:22 
  • Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-18 18:40
    • Recalled Paracetamol, a question for CMC gurus nobody 2019-06-18 20:44
      • Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 14:56
        • Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-19 15:24
          • Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 16:03
            • Recalled Paracetamol, a question for CMC gurus nobody 2019-06-19 16:04
              • Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 16:31
                • Recalled Paracetamol, a question for CMC gurus nobody 2019-06-19 16:41
                  • Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-19 16:48
                    • Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 17:10
                      • Recalled Paracetamol, a question for CMC gurusnobody 2019-06-19 17:40
                        • Recalled Paracetamol, a question for CMC gurus nobody 2019-06-28 11:51
                      • Recalled Paracetamol, a question for CMC gurus jag009 2019-07-01 02:41