Analytical method validation is necessary to ensure that the results obtained using a particular analytical method are accurate and precise. It is essential to make the right decisions based on the information obtained from the analysis. There are many factors that can affect the accuracy and precision ...

Before moving on to best practices for compliance, it’s important to understand the importance of compliance. Compliance with regulations is a guarantee of quality and safety of pharmaceutical products. It shows that the products are safe and effective. While non-compliance can lead to serious ...

1 According to GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that critical aspects of their specific operations are controlled. 2 The key elements of a company’s qualification and validation program should be clearly defined and ...

When you have a QMS in place, you can realize significant benefits such as improvements in: Organizational effectiveness: A QMS helps establish important operational goals while providing a way to measure and review how well your organization is reaching these goals. Customer satisfaction: A business ...

Maintenance of sterile areas is an important task because air, as well as personnel working in sterile classified areas, are major sources of contamination. Below are some good manufacturing practice points that will help maintain a sterile environment. 1. Precautions should be taken to minimize contamination ...

Before the GCP and similar regulations came into force, clinical trials were largely based on the needs of national governments rather than human rights. The GCP regulates human experimentation in the interest of advancing medical science. It acts as a quality benchmark as well as a moderator that keeps ...

Good Manufacturing Practice (GMP) is a set of standards that a manufacturer must meet to produce a safe and effective product. The most common GMP for pharmaceuticals is cGMP, which covers aspects such as process validation, quality control and documentation. Pharmaceutical manufacturers must meet all ...

Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug development to manufacturing and marketing. To ensure the compliance with all regulatory norms, pharmaceutical company needs to have a well-established monitoring system. ...

QA and GMP are about error prevention. However, in this imperfect universe there is no such thing as an incredibly perfect system, and an essential feature of any QA system is a plan to deal with complaints, or reports of defective products, should they occur. A requirement to cover this occurs in all ...

The line between internal audit and compliance may seem blurred at times, but they are quite different functions. Let me explain the difference between internal audit and compliance with an example. An example of a compliance review might be to check whether the organization’s systems comply with ...