After defining which business processes are cGxP relevant the next phase is to map them in detail. The following steps are performed: A. Identify the systems (both paper and electronic) involved in the processing of cGxP data B. Define individual cGxP data elements C. Identify cGxP data elements that can be modified, deleted, or…
When assessing data integrity risks within an organisation, companies may focus immediately on those systems or areas that are the most obvious in this context, such as a particular software, a specific lab system or instrument etc. Doing so creates the risk of forgetting less visible but still important areas, processes or systems, or…
Every pharmaceutical manufacturer must have and implement suitable processes for dealing with deviations from processes and quality specifications in order to continuously ensure the required quality of the products. There are many reasons for deviations. They range from quality problems in the raw materials, materials, equipment and devices used to inadequate description or implementation…
GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturingprocesses – from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products. Data integrity plays a key role…
Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of: Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO…
Have you ever wondered how pharmaceutical companies ensure the consistency and quality of their tablet formulations? In this post, we’ll explore how stratified sampling can be used to establish a strong correlation between these two important factors. Let’s dive in! By establishing a correlation between blend assay results and tablet content,…
1. Always wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and safety goggles. 2. Familiarize yourself with the laboratory’s emergency procedures and know the location of safety equipment like fire extinguishers and eyewash stations. 3. Keep your work area clean and organized to prevent accidents and cross-contamination. 4. Label all containers clearly…
1. Pre-inspection planning This involves determining the scope and objectives of the inspection, identifying the specific areas to be inspected, and gathering relevant information about the foreign facility. 2. Notification The regulatory authority or agency conducting the inspection notifies the foreign facility about the upcoming inspection, providing details such as the date, time, and…
