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Home » Topics » Pharmaceuticals » GMPs

GMPs
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Texas Pharmacy Warned for Using Domperidone

May 30, 2017
The FDA has warned a Texas pharmacy for numerous violations, including compounding unapproved drugs and unsanitary conditions. Read More

Supplement Company Draws Warning Over GMPs

May 25, 2017
A Utah supplement company drew a warning from the FDA for failing to comply with GMP requirements. Read More

PIC/S Hits European Commission Over Relaxed ATMP GMPs

April 12, 2017
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

PIC/S Hits European Commission Over Relaxed ATMP GMPs

March 16, 2017
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

FDA Clarifies ICH Guideline on Drug Starting Materials

March 14, 2017
More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Read More

PIC/S Hits European Commission Over Relaxed ATMP GMPs

March 14, 2017
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

PIC/S Hits European Commission over Relaxed ATMP GMPs

March 10, 2017
PIC/S says proposed EU rules easing GMP standards for ATMPs would increase liabilities for drug regulators. Read More

PIC/S Hits European Commission over Relaxed ATMP GMPs

March 6, 2017
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

February 24, 2017
The draft guidance covers the implementation of a single section of the Q11 manufacturing guideline.  Read More

FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

February 17, 2017
Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More

Wockhardt Gets Another FDA Warning Letter Over GMP Deficiencies

December 2, 2016
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More

German Regulators Find 35 Issues With Lab in India

September 17, 2016
Regulators in Germany have cited a lab in India with litany of GMP violations and have recommended a prohibition of supply. Read More
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