13 04, 2022

GMP/GDP Audits & the Importance of CAPA

By |2022-05-10T13:22:37+00:00April 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

24 02, 2022

Brexit and the Evolving Impact on the Pharmaceutical World

By |2022-05-10T13:36:23+00:00February 24th, 2022|Featured, Technical Article|

Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union. A transition period of 11 months began on 01 Feb 2020 until 31 Dec 2020. This transition period allowed for the UK to continue to follow EU rules while both sides worked out what the future EU/UK

2 02, 2022

New QTA requirements with Importation Site

By |2022-05-10T13:46:02+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 |2021-12-22T16:07:09+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 |2022-05-10T14:25:32+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? Active Pharmaceutical Ingredients or APIs must be manufactured in compliance with EU GMP and this compliance is confirmed by the QP declaration, which is submitted with the

19 08, 2021

Top 5 considerations when getting a Manufacturer’s/Importation Authorisation (MIA)

By |2022-05-10T14:41:25+00:00August 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

15 07, 2021

Best Practice for Virtual Audits

By |2021-10-13T14:10:38+00:00July 15th, 2021|Featured, Technical Article|

Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the pandemic. The regulatory authorities have published guidance on how they will perform their inspections by virtual/ remote audits or distant assessments during this restrictive period. There are several elements to

24 06, 2021

QTA – Best Practice Design

By |2021-10-13T14:15:09+00:00June 24th, 2021|Featured, Technical Article|

Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established! QTAs are established with manufacturers, suppliers and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the

19 07, 2019

GMP Requirements in the European Union

By |2019-07-19T12:43:01+00:00July 19th, 2019|Technical Article|

GMP Requirements in the EU: The contents of this article will discuss GxP, Good Manufacturing Practice, Good Distribution Practice and Market Authorisation Holder compliance overview. EU requirements differ from those anywhere else in the world. To import a product into the EU you must abide by European GMP requirements. There is

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