GMP (Good Manufacturing Practice)

Pharmaceutical quality management systems span the entire life cycle of a product, from development to use by patients. Quality assurance mechanisms are in place every step of the way; this is known as "good practice."

First published by the World Health Organization (WHO) in 1968, the good manufacturing practice has been amended and expanded over time. The EU GMP Guidelines are applicable in the EU but authorities in the Middle Eastern Region have become more flexible and are accepting these guidelines. The issuance of the Good Manufacturing Practice Certificate in Dubai is a relatively straight forward process. The Application submission, fee payment, and issuance are all governed by the Ministry of Health and Prevention

PRA assists pharmaceutical businesses and their QPs in implementing these guidelines into their own quality management systems, ensuring compliance with GxP recommendations, and demonstrating compliance to regulatory bodies during inspections. We create entire GxP quality management systems and offer quality assurance consulting.

You can get your certification through the following steps:

  • Apply for the Good Manufacturing Practice Certificate & pay the fees
  • Arrange for conducting an inspection, the report will be reviewed and the documents will be checked
  • The GMP Certificate will be issued if approved, and the documents submitted are legit

Get Regulatory Expertise Throughout Quality management (GxP)

Quality management system

We assist in establishing and monitoring your pharmaceutical QM system in line with cGDP and cGMP guidelines.

GMP consultation and audits

We support our clients in fully complying with GxP and similar guidelines while conserving resources.

Structures and processes

PRA supports pharmaceutical companies by analysing, optimising and implementing structures and processes in GxP and other areas.

Qualified person service

We support companies in fulfilling their legal obligations as manufacturing authorisation holders – and provide a qualified person (QP) on a short- or long-term basis

Open chat
Welcome to our live chat!
Hello 👋
Can we help you?