The Physical Site of Importation (SOI) plays a pivotal role in the pharmaceutical industry. It ensures Regulatory Compliance, upholding stringent EU/EEA standards. Additionally, SOIs enable Quality Assurance through critical physical inspections, guaranteeing the safety and efficacy of imported medicines. They serve as the final destination for batch certification by Qualified Persons (QPs) and act as
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
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
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
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'
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
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
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:
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
Supplier Qualification Audit; so you have completed your pre-qualification assessment and you are wondering what the next step is?
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