About Jill

Jillian Glancey | Marketing Executive
27 02, 2024

Vendor Requalification

By |2024-02-27T18:19:56+00:00February 27th, 2024|Featured|

In any compliant quality system the initial qualification of a vendor represents only the initial step in the relationship. Once initial audits are completed, Quality Agreements and Commercial contracts signed and your vendor moves into routine operation the countdown to their requalification should begin. Requalification audits represent an important element of the Quality System and

21 02, 2024

What is the CAPA process in Pharma Industry? 8 Steps

By |2024-02-27T13:36:06+00:00February 21st, 2024|Featured|

In the pharmaceutical industry, CAPA stands for Corrective and Preventive Action. CAPA is a quality management system approach used to identify, investigate, and address deviations, discrepancies, or non-conformances in processes, products, or systems. Effective CAPA processes are essential for maintaining product quality, ensuring compliance with regulatory requirements, and continuously improving operations in pharmaceutical manufacturing.  

31 01, 2024

Pros and cons of Incoterms in the Pharma Industry

By |2024-02-06T16:00:32+00:00January 31st, 2024|Featured|

Incoterms (International Commercial Terms), are a set of standardised terms used in international trade to define the responsibilities and obligations of buyers and sellers in the sale of goods. These terms are published by the International Chamber of Commerce (ICC) and are widely used in international contracts. Using Incoterms in the pharmaceutical industry has both

29 01, 2024

Roles of Importer, Declarant and Representative in Pharma

By |2024-02-12T11:28:18+00:00January 29th, 2024|Featured|

In the Pharmaceutical industry, the roles of an importer, declarant, and representative are particularly crucial to ensure that pharmaceutical products are imported, declared, and represented correctly and in compliance with strict regulatory requirements. These roles help ensure the safety, efficacy, and quality of pharmaceutical products. Here's how these roles are relevant in the pharmaceutical industry:

24 01, 2024

The Customs Process and Incoterms for the Pharma Industry

By |2024-02-12T15:46:19+00:00January 24th, 2024|Featured|

To import into the European Union (EU) or Great Britain (GB) for a company without a presence in Europe or GB there are three key roles that must be considered as part of this process namely the roles of Customs representative means any person appointed by another person to carry out the acts and formalities

14 12, 2023

Advantages and Disadvantages of direct to UK shipment for clinical trials

By |2024-01-16T16:13:50+00:00December 14th, 2023|Featured|

Direct shipment to the UK clinical trials can have its advantages and disadvantages. When it comes to clinical trials, there are specific considerations due to the nature of the products and the regulatory requirements involved. Here are some advantages and disadvantages of direct shipment for clinical trials to the UK: Advantages: Timely Access: Direct shipment

11 12, 2023

RPi process (leveraging EU certification)

By |2023-12-11T14:04:18+00:00December 11th, 2023|Featured|

A Responsible Person for Imports (RPi), plays a crucial role in ensuring that products imported into the European Union (EU) comply with EU certification and regulatory requirements. This role is particularly important for certain product categories, such as medical devices. Leveraging EU certification through an RP in the import process involves several key steps and

27 11, 2023

Trials or Post-Brexit Imperative: A Guide to Successful UK-EU Clinical Trials Compliance

By |2023-11-27T13:28:37+00:00November 27th, 2023|Featured|

Achieving success in a UK-EU clinical trial requires the implementation of effective strategies for the release of Investigational Medicinal Products (IMPs), demanding careful planning and strict adherence to regulatory standards. The management of IMPs in trials spanning multiple jurisdictions is intricate, with the MHRA and EMA holding pivotal positions. MIAS Pharma, dedicated to serving Ireland

3 11, 2023

How would an Auditor qualify a warehouse provider to ensure they are in compliance with Annex 21?

By |2023-11-03T14:45:38+00:00November 3rd, 2023|Featured|

Annex 21 of the Good Manufacturing Practice (GMP) guidelines for medicinal products outlines the requirements for the importation of medicinal products into the European Union (EU). Warehouse providers involved in storing and handling medicinal products for importation must comply with these guidelines. To qualify a warehouse provider and ensure they are in compliance with Annex

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