29 09, 2023

Function of the RP (Responsible Person)

By |2023-09-27T15:36:59+01:00September 29th, 2023|Featured|

The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) guidelines, is to ensure the integrity, safety, and quality of pharmaceutical products throughout the entire distribution process. The RP plays a critical role in maintaining compliance with regulatory requirements and safeguarding public health. Here

28 09, 2023

The Role of GDP in preventing falsified Medicines

By |2023-09-27T15:36:28+01:00September 28th, 2023|Featured|

The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) plays a crucial role in preventing falsified medicines from entering the legitimate pharmaceutical supply chain. Falsified medicines are counterfeit or substandard drugs that can pose serious risks to patient health. Here's how GDP contributes

27 09, 2023

UK Requirements for a RP to be on a Wholesale Distribution Authorisation (WDA)

By |2023-09-27T14:50:12+01:00September 27th, 2023|Featured|

The Responsible Person (RP) on a UK Wholesale Distribution Authorisation (WDA) for pharmaceuticals has specific responsibilities to ensure that imported pharmaceutical products are distributed in compliance with Good Distribution Practice (GDP) and regulatory requirements. Here are the key requirements and responsibilities for the RP on a UK WDA: Qualifications and Experience: The RP must have

30 08, 2023

ATMPs and why you should use MIAS Pharma as your Batch Certification partner of choice

By |2023-09-03T21:45:53+01:00August 30th, 2023|Featured|

Advanced therapy medicinal products ( (ATMPs) are medicines that are based on genes, tissues or cells which offer groundbreaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types:   Gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant'

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

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