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

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

As a Marketing Authorisation (MA) holder in the European Union (EU), a pharmaceutical company has several responsibilities. These responsibilities are aimed at ensuring the quality, safety, and efficacy of the authorized medicinal product throughout its lifecycle. Here are the key responsibilities of an MA holder in the EU: Product Quality and Compliance: The MA

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

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

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

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

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

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

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