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Global Regulatory requirements for Good Manufacturing and Distribution practices in Pharmaceutical /Biopharma industries (GRRMDP) is a system for ensuring that pharmaceutical products are consistently produced, controlled and distributed according to established quality standards of regulatory guidelines. It is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product and throughout the Lifecycle of the product.

 

All guidelines follow few basic principles:

The production and distribution of the drugs must minimize any risk to their quality. Manufacturing facilities must maintain a clean and hygienic manufacturing area, including laboratories and storage.

Regulatory compliances refer to the process and activities a company undertakes to ensure that it adheres to all applicable laws and regulations. The pharmaceutical industry is highly regulated, with numerous regulatory agencies overseeing different aspects of drug development, manufacturing and marketing.

Nearly all countries have a regulatory agency aimed at protecting citizens from harmful drugs and ensuring product quality. Besides the US FDA, Regulatory agencies include EMA in the European Union, TGA in Australia, MHRA in the United Kingdom and MCC in South Africa to name a few.

These regulatory guidance documents set forth by the health agencies of different countries provide the industry an insight to the current thinking on a particular subject in the manufacturing of the drug. Regulatory Guidance primarily ensures the safety of the patients and efficacy of the drug. A Regulatory non-compliance can have a profound negative impact on a pharma company’s finances, reputation and customer.

Manufacturers should establish and execute their policies and procedures in accordance with regulatory requirements, guidance and consensus standards to be regulatory compliant.

Non compliance to the guideline requirements by the manufacturing units may lead to many observations during Regulatory audits and may receive warning letters also.

We have tried to compile Global Regulatory Requirements (country wise) for good manufacturing practices in pharmaceutical/biopharma industries that are required to comply by the departments in the industry. If the requirements are understood and met, possibility of receiving 483s or warning letters could be avoided.

Look out for this page for the current guidance documents, recent industry news, articles, presentations and GMP related discussions that we will be sharing from time to time.

 

You can also contact Ms. Prema Desai / Ms. Bharathi Ramesh for any specific queries.

Write to us for any specific requirements at: regulatorygrrmdp@gmail.com

As the famous adage goes, a journey of 1000 miles begins with a single step.