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Category Archives: Publication

Temperature Mapping Service in London: Accurate Solutions for Regulatory Compliance

In the pharmaceutical and biotech industries, maintaining the integrity of temperature-sensitive products is crucial. Temperature mapping services in London ensure storage conditions stay within required ranges, supporting quality assurance and regulatory compliance. Temperature mapping ensure…

9 December 2024 Inglasia Pharma Solutions

Operating an un-validated system feels like looking for a needle in a haystack!

Publication, Uncategorised

When computerised systems are identified and their capabilities assessed and challenged, this provides you with assurance that they can be promptly relied upon to give you the data you need, when you need it. Below is a list of considerations, when you are assessing the suitability for use of …

3 December 2024 Inglasia Pharma Solutions

Without procedures, we will have no deviations!

Publication

Majority of deviations raised result from poorly written procedures Procedures give us direction, structure and consistency in how we perform our daily tasks in ensuring medicines are manufactured and handled with the utmost care. They are a requirement to comply with our regulations, where …

3 December 2024 Inglasia Pharma Solutions

How CSV Services Enhance Data Integrity and Compliance in Pharma

Publication, Uncategorised

Computer System Validation (CSV) services ensure data integrity, regulatory compliance and operational efficiency in the pharmaceutical and biotech industries. These sectors require precision and adherence to strict global standards to safeguard product quality and patient safety. CSV fr…

29 November 2024 Inglasia Pharma Solutions

Medicines Recall Process – Overview

Publication

Departments and external stakeholders must work together to expedite recalls The above process overview highlights the main considerations when executing a medicinal product recall. When a notification of a recall is received by the MAH (marketing authorisation holder in Country for the medici…

26 March 2023 Inglasia Pharma Solutions

Responsible Person (Import) – Requirements

Publication

Minimum checks required on medicinal product imported from an *EEA Country by a business in Great Britain (GB) If your business in GB is looking to import medicinal products from the EEA, there are a number of checks which must be performed by the Responsible Person, prior to release for sale …

4 February 2023 Inglasia Pharma Solutions