Clean Room Pressure Cascades When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor,…
A standard operating procedure (SOP) provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently. The fundamental purpose of an SOP is to provide clear and concise instructions for the consistent execution of routine operations within an organization. By offering a step-by-step guide on how tasks…
A new Warning Letter has been issued by the U.S. Food and Drug Administration (FDA) and published on their website on August 1, 2023. The document, dated July 28, 2023, pertains to an inspection from November 22 to December 2, 2022, at a drug manufacturing facility in Sanand (Gujarat, India). The company under scrutiny is…
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…
