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Surviving Brexit – How will Brexit Impact the Pharmaceutical Industry?

By Rachael Crook, QA Associate, inglasia pharma solutions With Brexit looming in March 2019, it has been inevitable from the start …

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Data Integrity: To see or not to see? – that is the question

Thinking point 1: “Quality” is a living sense of awareness that should pervade the pharmaceutical industry, data integrity is but …

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How To Make Presentations Enjoyable and Most Importantly, Engaging!

We will all have to make a presentation at some point in our lives. It might be presenting at an …

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How To Build Your Self-Confidence

When thinking too far ahead the mind can start to process too much information and this can make you doubt your abilities …

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The Quality Control Release System

In defining the overall system for Quality Control release of finished products, it is for the manufacturing organisation to decide …

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Good Distribution Practice Guidelines – Some frequently asked questions and their answers

The European Commision has collated a number of frequently asked questions from industry in relation to the new EU guidelines on Good …

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The Rationale for Setting Cleaning Limits in Active Pharmaceutical Ingredient (API) Manufacture

The general rationale behind setting cleaning limits is described below. The contaminant (A) refers to the compound being cleaned, and …

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IPS Good Distribution Practice Online Course – Accredited by the Royal Pharmaceutical Society

We are please to announce our online Good Distribution Practice course has been accredited by the Royal Pharmaceutical Society (RPS) …

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Cleaning Validation – The Matrix Approach

Where there are multiple medicinal drug products coming into contact with equipment surfaces there is the opportunity to apply the …

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Cleaning Validation – Documentation Requirements

Introduction The cleaning of pharmaceutical equipment is an area of regulatory importance. The potential for cross contamination of materials is …

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Medicinal Products – Batch Packaging Records – GMP controls

Batch packaging records should include the following elements: Product name and pack reference code Batch number of bulk product Batch …

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GMP Multiple Choice Assessment Answers (Questions posted on Linkedin Group 1 June 13)

1) The system of Quality Assurance appropriate for the manufacturer of medicinal products should ensure that: a – Managerial responsibilities …

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The EMA 2012 Guidance for Process Validation, by Dr Peter Calcott

This article was originally published on 19 February 2013, for the Master Control website and its publication GxP Lifeline In …

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Audit Situations on API Manufacture – a scenario and suggested answer

Scenario 1 A firm has bought a new piece of equipment. It is similar but not identical to existing equipment …

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Pharmaceutical Regulatory Harmony?

Emerging Markets and the challenges they face

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Atypical or Aberrant Results: OOS/OOT scenario with inglasia suggested answers

(scenarios originally published within inglasia Linkedin group: GMP/GDP Quality Management Documents and Training for Pharmaceutical Companies) Consider the following scenarios …

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Is Quality by Design just for Big Pharma? By Dr Peter Calcott

This article was originally published on 5 June 2012 for the Master Control website www.mastercontrol.com and its publication GxP Lifeline …

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New EU GDP Guidelines (2013/C 68/01), versus, The Consultation Paper: radically different or a few minor tweaks?

An Analysis By Sanjay Nadarajah 7th March 2013, is a landmark date in the evolution of Good Distribution Practice. As …read more

An Audio introduction to the New Guidelines by Sanjay Nadarajah

This audio presentation provides us with a brief introduction to the New Guidelines. This clip discusses the background for change and gives …

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