Quality Culture Guidance

Quality Culture

Before we can understand quality culture, we must first ask ourselves “what is quality?”. When YOU, the reader, think of quality, what comes to mind? The fact is, the answer to this question isn’t that straightforward, and is debated even today by...

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12 Responsibilities of the RP Guidance

12 Responsibilities of the RP

The 12 RP responsibilities, and the Role of the Deputy The RP responsibilities within a wholesaler operation, involve ensuring compliance with the conditions of the license and safeguarding the quality of the medicinal products handled. They will...

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Driver Training Guidance

Driver Training

DRIVER TRAINING – the demand for trained drivers Haulage management are under constant pressure to urgently fill driving seats to keep stock and goods moving. It is not implausible that promised driver training after hiring (in many cases) may not...

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Common Deficiencies Guidance

Common Deficiencies

In November 2017, the MHRA released a document that contained common deficiencies data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01,...

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Documentation to GDP Compliance Guidance

Documentation to GDP Compliance

GDP Compliance in Documentation Documentation is an essential part of GDP, as it provides evidence of the actions taken by the distributor to demonstrate compliance with the applicable regulations and guidelines. Documentation also facilitates...

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What is a Responsible Person? Guidance

What is a Responsible Person?

A responsible person (RP) is a key figure in the pharmaceutical supply chain, who ensures that the quality and integrity of medicinal products are maintained throughout the distribution process. The RP is named on the wholesale distribution...

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WHAT IS A QMS (Quality Management System)? Guidance

WHAT IS A QMS (Quality Management System)?

The Importance of a Healthy and Compliant QMS A quality management system (QMS) is a set of policies, procedures and processes that aim to ensure that the quality and integrity of products and services are maintained throughout their lifecycle.  A...

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WHAT IS A RISK ASSESSMENT IN GDP? Guidance

WHAT IS A RISK ASSESSMENT IN GDP?

Risk Assessment within a Good Distribution Practice Environment. Good Distribution Practice (GDP) is the minimum standard that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the...

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