7 02, 2023

QP Declaration for Investigational Medicinal Products

By |2024-03-26T09:50:07+00:00February 7th, 2023|Technical Article|

When submitting a trial application for a clinical trial in the EU/EEA using an Investigational Medicinal Product (IMP) manufactured in a 3rd country (a country not a member of the EU or EEA), a Qualified Person’s (QP) Declaration is required. This declaration is intended to guarantee that the IMP has been manufactured to standards at

13 12, 2022

QP Audits to ensure GxP Standards

By |2023-03-14T15:10:06+00:00December 13th, 2022|Featured, Technical Article|

Introduction For any organisation that plays a role in the supply of pharmaceutical products such as manufacturing, QC testing, packaging, storage and distribution, an audit is an essential exercise to evaluate the level of compliance to the required GxP standards. All personnel operating or supporting the manufacturing of medicines are required to understand the current

13 04, 2022

GMP/GDP Audits & the Importance of CAPA

By |2022-05-10T13:22:37+01:00April 13th, 2022|Featured, Technical Article|

The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and standards to which our suppliers and contractors operate. It is important for us to have confidence in the quality of the materials and products that are manufactured and analysed and in control of

2 02, 2022

New QTA requirements with Importation Site

By |2023-03-14T14:36:57+00:00February 2nd, 2022|Featured, Technical Article|

The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union. As required by the HPRA “A manufacturer’s authorisation (MIA) is needed if a company is involved in any of the following manufacturing activities:  processing of a dosage form, primary packaging, secondary packaging, batch certification,

22 12, 2021

EMA Reflection Paper on GMP & MAHs – considerations for QPs

By |2023-03-14T14:31:05+00:00December 22nd, 2021|Featured, Technical Article|

In July 2021, the European Medicines Agency (EMA) published the final reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder" after a period of consultation with the relevant stakeholders. The document focuses on and describes the good manufacturing practice (GMP) responsibilities applicable to Marketing Authorisation Holders (MAHs). With the rise in virtual

28 10, 2021

Good Practices for Data Management and Integrity

By |2021-11-08T13:49:48+00:00October 28th, 2021|Featured, Technical Article|

The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it's life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally.  Data integrity failure may involve omissions,

23 09, 2021

QP Declarations – Key Considerations

By |2024-03-26T10:39:06+00:00September 23rd, 2021|Featured, Technical Article|

So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need to work towards? You must first understand the difference between QP Certification and a QP Declaration. QP Certification is the process by which the QP verifies that the batch has

19 08, 2021

Top 5 Considerations when Getting a Manufacturer’s/Importation Authorisation (MIA)

By |2024-04-30T10:47:39+01:00August 19th, 2021|Featured, Technical Article|

A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to human, veterinary or investigational medicinal product, within the EU.  The term manufacturing and/or importation includes any of the following manufacturing activities as detailed by the HPRA:  processing of a dosage form, primary packaging, secondary packaging, batch

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