Process and Regulatory Expectations To be an EU GMP-Certified Pharma Company

By: November 17, 2021

The EU GMP certification unlocks greater market access for EU GMP-certified pharma companies in India. It allows it to sell products in all the 27 member countries of the EU and access the European Economic Area (EEA) countries.

About EU GMP Certificate

Good manufacturing practices (GMP) explain the bare minimum standard that a pharmaceutical medicines manufacturer must meet in their production facilities. The EMP regulates inspections for verifying standard compliance and plays a crucial role in harmonizing GMP pursuits at the EU level.

Any EU-GMP Certified Manufacturers of pharma medicines intended for the EU market, regardless of where in the world they are located, should comply with GMP.

GMP demands that medicines:

  • are of consistently high quality;
  • are appropriate for their intended use;
  • meet the requirements of the clinical trial authorization or marketing authorization.

EMA Role

The Agency regulates GMP reviews of EU-GMP Approved Pharmaceutical Plants for medicines whose marketing authorization in the EU is submitted by the centralized system or as part of a referral method.

The Agency additionally plays a pivotal role in regulating and harmonizing GMP activities at an EU level. It is involved in:

  • harmonize the preparation of new and revised guidelines on GMP;
  • ensuring general interpretation of EU-GMP requirements and related technical problems;
  • developing EU-wide procedures/guidelines on GMP inspections and related activities;
  • providing collaboration between the Member States for inspections of manufacturers in third nations.

Marketing sanction owners and aspirants should utilize EMA’s IRIS system to interact with EMA, or GMP inspections inquired by the Agency’s scientific committees.

Utilizing IRIS for GMP inspections improves efficiency by harmonizing and automating processes and re-using master data held by EMA. It further simplifies retrieving and reporting data.

Registration of Manufacturers of Active Substances

Producers of active substances intended to manufacture human drugs for the EU market must register with the Member State’s competent national authority.

Active substance manufacturers should comply with GMP. Moreover, the finished product manufacturer must ensure that the active substances they utilize have been manufactured in compliance with GMP.

Importers of active substances designed for the EU market are additionally needed to register. Further, each consignment should be accompanied by a confirmation by the country’s competent authority where it is produced to conform to GMP standards equivalent to those in the EU unless a waiver applies.

Joinhub Pharma – Top EU-GMP Approved Companies in India

When it comes to choosing the best pharma company from the List of EU GMP-certified companies in India, JoinHub Pharma ranks on top.

JoinHub Pharma is a European Union (EU) GMP-certified pharmaceutical manufacturing company in India with a manufacturing facility located in Ahmedabad, Gujarat.

The company manufactures a wide range of pharma products at its Ahmedabad – EU-GMP Approved Pharmaceutical Plants Facility and manufactures a wide range of pharma products such as respiratory system, dermatology, gynecology, gastro, anti-infective, anti-malaria, anti-bacterial, anti-diabetic, pain management, etc.

The company’s in-house Quality Assurance team has helped them maintain very high-quality standards ensuring utmost ease in meeting the stringent demands required by Food & Drug organizations worldwide. This has assisted in gaining easy & quick access to overseas markets.

Building on core values of focus, teamwork & product development, they have achieved continuous growth since our establishment. Their primary aim is to be a global leader in offering premium quality health supplements and sports nutrition and in being known worldwide for their contribution in raising the quality of life of those who want to enjoy the benefits of an active lifestyle and healthy diet.

Get in touch with experts at JoinHub Pharma to get the premium quality, reliable, honest, and high customer satisfaction rated pharma products.

Simply drop us a line at [email protected] or call us directly. We’ll reach out to you within 24 hours.

JoinHub Author
JoinHub Pharma
JoinHub Pharma is the swiftest and biggest developing pharmaceutical companies in India, with headquarters at Ahmedabad, Gujarat. We at JoinHub Pharma are committed to our employees and customers and all the more significantly, to the people who depend on our medicines.
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