Dr Reddy’s to participate in US pharma programme

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Dr. Reddy's Laboratories Ltd . today announced that it has signed on as the first participant in United States Pharmacopoeia's (USP) Pharmaceutical Ingredient Verification Programme.

 

"Participating in this programme shows that Dr. Reddy's Laboratories shares USP's commitment to good pharmaceutical care throughout the world," said Dr. Roger Williams, Chief Executive Officer and Executive Vice-President of USP.

 

"We look forward to participating in this programme so that we can show manufacturers, regulatory authorities and consumers our dedication to producing pharmaceutical ingredients that are of consistently high quality," said Satish Reddy, Chief Operating Officer and Managing Director of Dr. Reddy's Laboratories Ltd.

 

USP created the Pharmaceutical Ingredient Verification Programme in response to increasing concerns throughout the pharmaceutical industry about the quality and consistency of pharmaceutical ingredients. The programme enables manufacturers to show the quality and integrity of their ingredients with a recognizable 'USP Verified' mark.

 

As a participant in the Pharmaceutical Ingredient Verification Programme, Dr. Reddy's will submit ingredients to USP's verification process, which includes:

Evaluation of an ingredient manufacturer's quality systems through an audit for compliance with Good Manufacturing Practices (GMPs)

 

Review of manufacturing and quality control documents for the ingredients

 

Laboratory testing of ingredient samples from USP-selected lots for compliance with USP's FDA-enforceable standards for purity, potency and quality

 

Post-verification surveillance testing of ingredients bearing the USP Verified mark.

 

Once each ingredient passes the verification process, Dr. Reddy's will receive a Certificate of Standards Compliance. They will be permitted to post the 'USP Verified' mark on the shipping container, and certificate of analysis demonstrating that it meets USP's world-class quality standards.

  

Sourced From: Genesis Burson-Marsteller