29 08, 2023

Key differences between ATMPs and other complex products

By |2023-08-29T15:40:00+01:00August 29th, 2023|Featured|

Advanced Therapy Medicinal Products (ATMPs) are a category of innovative medical products that includes gene therapies, cell therapies, and tissue-engineered products. These therapies are designed to treat or potentially cure diseases by using advanced technologies to manipulate the patient's genes, cells, or tissues. Comparing ATMPs to other complex products, such as traditional small molecule drugs

23 08, 2023

ATMP’s as the future of Personalised Medicine

By |2023-08-23T15:42:28+01:00August 23rd, 2023|Featured|

Advanced Therapy Medicinal Products (ATMPs) hold significant promise in shaping the future of personalised medicine. Personalised medicine aims to provide medical treatments and interventions tailored to the individual characteristics of each patient. ATMPs, which include gene therapies, cell therapies, and tissue-engineered products, are particularly well-suited to fulfill this vision due to their unique attributes: Individualised

31 07, 2023

When is it ok to do a remote Pharmaceutical Audit vs an on-site Audit?

By |2023-07-31T11:50:30+01:00July 31st, 2023|Featured|

The decision to conduct a remote pharmaceutical audit or an on-site audit depends on various factors and should be made based on a risk-based approach, regulatory requirements, and the specific circumstances of the audit. Here are some considerations for when it may be appropriate to conduct either type of audit: Remote Pharmaceutical Audit: Low-Risk Areas:

31 07, 2023

What indicators would you look for to set Pharmaceutical Audit frequency?

By |2023-07-31T11:08:37+01:00July 31st, 2023|Featured|

Setting the pharmaceutical audit frequency involves considering various indicators and factors to ensure that the auditing process is effective and risk-based. The goal is to maintain compliance with regulations, identify potential issues, and continually improve the pharmaceutical quality management system. Here are some key indicators to consider when determining the audit frequency: Regulatory Requirements: Comply

24 07, 2023

Supplier Qualification Audit; so you have completed your pre-qualification assessment and you are wondering what the next step is?

By |2023-07-24T13:12:37+01:00July 24th, 2023|Featured|

The answer lies in a qualification audit. While a pre-qualification assessment can help identify surface deficiencies in the way a company operates, a qualification audit is a deeper dive into the background details. It is a more thorough step to ensuring that your potential new partner/client operates in a manner that prioritises patient safety and

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 |2024-05-10T16:40:02+01:00June 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

Go to Top