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Setting Risk Targets for Inspection of Pharmaceutical Companies in Low and Middle Income Countries: A Four Step Approach

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Pharmaceutical companies are indispensable in providing essential medicines to the global population. However, in low and middle-income countries, the regulation of these companies is often insufficient, leading to risks of substandard, falsified, or counterfeit medicines. To ensure compliance and the delivery of safe and effective medicines, inspection of pharmaceutical companies is essential. The challenge, however, […]

Internal Auditor Questionnaire: Ensuring Compliance and Best Practices

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In the pharmaceutical industry, maintaining compliance and adhering to best practices is critical to ensuring the safety and efficacy of drugs and medical devices. With the ever-changing regulatory landscape, it can be challenging for companies to keep up with the latest requirements and standards. In order to meet these requirements, companies must establish internal audit […]

Continuous Manufacturing vs Batch Manufacturing: a Head-to-Head Comparison & Key Considerations

Continuous manufacturing (CM) or more specifically Pharmaceutical Continuous Manufacturing (PCM) is the future of pharmaceutical production, a process that a continuous stream of materials through the production line and replaces traditional batch production. It offers various advantages such as improved quality, increased efficiency, reduced manufacturing costs, and enhanced safety. However, it is not free from […]

How social listening tools allow healthcare brands to uncover a wide range of metrics to boost engagement and loyalty (Time Horton’s Story Inside)

Healthcare brands have an ever-growing responsibility to ensure the satisfaction and protection of their consumers. With the proliferation of social media, online reviews, and other digital platforms, it has become increasingly important for healthcare brands to actively listen to the voice of the consumer. Social listening tools have emerged as a crucial instrument to achieve […]

Pharmacy Auditor Questionnaire: Ensuring Compliance and Best Practices

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The regulations governing pharmacy facilities are aimed at ensuring the safety of patients and the proper handling, storage, and dispensing of drugs including controlled substances. The rules also mandate that pharmacy staff maintain accurate records and documentation of all transactions and prescriptions. Additionally, pharmacies must follow strict guidelines for the handling and disposal of hazardous […]

Quality Management System (QMS) vs Pharmaceutical Quality System (PQS): a Head-to-Head Comparison & Key Considerations

Quality Management System (QMS) refers to a set of interrelated or interacting elements that guide an organization in achieving quality objectives and continuously improving its processes, products, and services. On the other hand, PQS focuses specifically on pharmaceutical products’ safety, efficacy, and quality throughout their life cycle, including research and development, manufacturing, distribution, and post-market […]

Pharmacist Guide to Risk Assessment in Pharma Manufacturing

As the pharmaceutical industry continues to grow and evolve, risk assessment has become an increasingly important aspect of pharma manufacturing. It is critical that pharmacists have a thorough understanding of the risks involved in the manufacturing process, as they play an important role in ensuring the safety and efficacy of medications. A comprehensive risk assessment […]

From Process to Product: How ICH Q10 PQS Features Ensure Quality in the Pharma Industry

The ICH Q10 Pharmaceutical Quality System (PQS) is an essential quality management system utilized in the pharmaceutical industry, which aims to ensure the highest quality in regards to the development and manufacture of pharmaceutical products. Quality is an essential aspect of the pharmaceutical industry, and the ICH Q10 provides a comprehensive and systemic approach to […]

15 Critical Performance Indicators and metrics for Risk-Based Inspections in Low and Middle Income Countries – what they are and how to use them

In the modern world, it is essential that organizations take proactive steps to ensure that their operations are conducted in a safe and compliant manner. This is especially true in low and middle-income countries, where the risk of non-compliance is higher due to the lack of regulation and enforcement. A risk-based inspection (RBI) is a […]

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