28 03, 2023

WDA and its importance

By |2023-03-28T11:08:41+00:00March 28th, 2023|Technical Article|

A wholesaler distribution license is a permit issued by regulatory agencies that allows a company or individual to distribute pharmaceutical products, medical devices, or other healthcare products at a wholesale level. The license is granted to companies that meet specific regulatory requirements, such as having appropriate storage and handling facilities, qualified personnel, and adherence to

21 03, 2023

What is an RP (Responsible Person) in pharmaceutical industry?

By |2023-03-21T10:13:14+00:00March 21st, 2023|Technical Article|

An RP, or Responsible Person, is an individual who holds a key role within a pharmaceutical company that holds a Wholesale Distribution Authorisation (WDA). The RP is responsible for ensuring that the company complies with all regulatory requirements for the distribution of medicinal products and for maintaining a compliant Quality Management System (QMS).  The role

16 03, 2023

Importance of matching the correct QP to your product

By |2023-03-16T13:55:56+00:00March 16th, 2023|Technical Article|

Introduction: MIA for Marketed Products: Importance of matching the correct QP to your product As science advances the types of products on offer have grown in complexity. From Oral Solid Dosage Forms  (OSD) to novel Cell and Gene Therapy products, the range of technical knowledge required is vast. At the very end of the manufacturing

1 03, 2023

QP Certification for the EU and Rest of the World

By |2023-03-14T15:45:33+00:00March 1st, 2023|Featured, Technical Article|

How times flies! It’s almost seven years since the new revision of Annex 16 of the EU GMP Guide: Certification by a Qualified Person and Batch Release, came into effect on 15th April 2016. It was introduced due to the increased complexity of global supply chains as it was felt that the previous guidelines, relating

7 02, 2023

QP declaration for Investigational Medicinal Products

By |2023-03-14T15:54:15+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

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+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 |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

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