27 06, 2023

Disposition of Medicinal Product to the UK market following EU QP Release

By |2023-06-27T11:49:10+01:00June 27th, 2023|Featured, Technical Article|

The Qualified Person (QP) Role is well established for certification of medicinal products in the European Union (EU) and European Economic Area (EEA). It was first introduced in EU Directive 75/319/EEC, replaced with Directive 2001/83/EC and most recently further defined in Annex 16 of the EU Good Manufacturing Practice (GMP) guidelines. The QP plays

7 06, 2023

How Should a Pharma Company Approach Supplier Qualification

By |2024-03-12T11:08:27+00:00June 7th, 2023|Featured, Technical Article|

Supplier qualification is a critical process for pharmaceutical companies to ensure the quality and reliability of the materials, components, and services provided by their suppliers. Here are some key steps and considerations for approaching supplier qualification: Define Supplier Requirements: Start by clearly defining the specific requirements for suppliers based on the type of product

6 06, 2023

Responsibilities of a Pharma Company MA holder in the EU

By |2024-03-26T10:29:24+00:00June 6th, 2023|Featured, Technical Article|

Who is an MAH (Marketing Authorization Holder)? The MAH is the company that holds the authorization to place a product on the market in the European Union. Therefore, they hold the ultimate responsibility that all aspects of the manufacture, testing, and distribution of their product is in compliance with what has been approved by

30 05, 2023

What are the different types of EU GMP Audits that Pharma companies carry out?

By |2023-12-19T17:00:50+00:00May 30th, 2023|Featured, Technical Article|

Pharmaceutical companies carry out various types of audits to ensure compliance with the European Union (EU) Good Manufacturing Practice (GMP) regulations. Here are some of the different types of EU GMP audits commonly conducted by pharma companies: Self-Inspection/Internal Audit: This is an internal audit conducted by the pharmaceutical company itself. It involves assessing the

30 05, 2023

How important is it for Pharma companies to implement a robust Audit program?

By |2023-05-30T15:30:53+01:00May 30th, 2023|Featured, Technical Article|

Implementing robust audit programs is of significant importance in pharmaceutical companies for several reasons: Compliance with Regulations: The pharmaceutical industry is highly regulated, and companies must adhere to various regulatory standards and guidelines, such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). Robust audit programs help ensure that

30 05, 2023

How does Annex 21 effect Pharma Companies in 2023

By |2023-05-30T14:38:12+01:00May 30th, 2023|Featured, Technical Article|

The EU-GMP Guideline of Annex 21, titled "Importation of Medicinal Products," provides guidelines for pharmaceutical companies importing drugs into the European Union (EU). This annex sets out the requirements and procedures that companies must follow to ensure the quality, safety, and efficacy of imported medicinal products. Here are some key points regarding how Annex

10 05, 2023

The Importance of GDP in Radiopharma

By |2023-05-10T12:42:11+01:00May 10th, 2023|Featured, Technical Article|

GDP (Good Distribution Practice) is essential in Radiopharma Clinical Trials because it ensures that the medicinal products being used are of consistent quality and are delivered to the clinical trial site in a safe and secure manner. GDP guidelines are designed to ensure that all aspects of the clinical trial supply chain, from manufacturing

9 05, 2023

Practical considerations for QP release of Radiopharmaceutical clinical trials into Europe

By |2023-06-27T11:55:56+01:00May 9th, 2023|Featured, Technical Article|

Radiopharmaceuticals are used in the specialised area of nuclear medicine (clinical imaging and therapy) to diagnose, evaluate and treat diseases. The use of radiopharmaceuticals covers a broad range of procedures such as: diagnosis (single photon emission computed tomography, SPECT; and positron emission tomography, PET) radiation therapy (for oncology and palliative pain management) early research

25 04, 2023

What does a Pharma company need to do to become Annex 1 compliant and how could MIAS Pharma Ltd help

By |2023-04-26T14:00:42+01:00April 25th, 2023|Featured, Technical Article|

Annex 1 of the European Union's Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. To become Annex 1 compliant, a pharma company needs to ensure that its manufacturing processes and facilities meet the standards outlined in the guideline. The following are some of the key requirements

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

Go to Top