Industry news

CDSCO (India) Announced That Imported Drug Products Must Meet Indian Medicinal Products Requirements

The Indian drug regulatory agency Central Drugs Standard Control Organization (CDSCO) announced on March 4 that drug products imported into India must comply with Indian requirements for the manufacture of medicinal products.

CDSCO has increased surveillance of medical products imported into I...

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How to cope with an unprecedented level of change?

The pharmaceutical industry is facing a blizzard of new legislation and guidance. How can quality professionals and their senior management cope with this? Are senior management even aware of much of this change? Some of the changes (ICH Q10, EU GMP Chapters 1 and 2) make it very clear that ulti...

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Career Paths, Our New Training Concept

One of the most frequent questions tutors are asked after one of our training courses is “That was great, but what should I do next?”

It is clear that many of you are wisely considering where you want to be in five years.

As such, we are introducing some tools to help you see how a training...

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Draft EU GMP Annex 15

The long expected draft of EU GMP Annex 15 on Validation has been published.

The key points are as follows:

• URS has finally been added to the section on Qualification for Facilities and Equipment, as has Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT)
• Process Validation i...

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EU FMD Safety Features

It has been reported this week that the European Commission has completed its impact assessment and is proceeding to draft a delegated Regulation to propose the following:

1. That the composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique i...

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