As a QA personnel I have some nightmares like: -How many filing cabinets will require to keep every batch record organized in order to manufacture your products? -Are there numerous papers that require review? -Are any documents missing? Many people view maintaining paper records as a necessary evil. The benefits of switching to digital…
These are checks that are carried out before the manufacturing process is completed. The function of in-process controls is monitoring in order to comply with the specifications .It may include control of equipment and environment too. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing…
What is Regulatory Affairs? Professionals in this field implement regulations from local, state and federal governing bodies to ensure compliance. They also stay up to date on the latest policy changes and recommend new organization protocols as necessary. RA professionals work in Bio pharmaceutical, pharmaceutical and medical devices industries What is Quality Assurance (QA)?…
What is In process checks? In process checks are checks performed during an activity,In order to monitor and,if necessary, to adjust the process to ensure that product confirms to its specification. What are the check point during line clearance of granulation area? Why granuation is important? To improve powder flow. To improve compressibility….
OOS is a term commonly used in the pharmaceutical industry to describe a situation where a test result of a pharmaceutical product, material, or sample falls outside the predetermined specifications or acceptance criteria. An OOS result indicates that the product or material may not meet its intended quality standards and could potentially pose risks…
OOT in pharmaceutical analysis refers to a situation where a pharmaceutical product or process parameter falls outside the expected or established trend over time. Trends are usually established through a series of measurements or tests conducted during product development, manufacturing, and quality control. These trends help ensure consistency and quality of pharmaceutical products. Deviations…
1. Establish a robust CAPA process: Implement a well-defined and documented Corrective and Preventive Action (CAPA) process that is aligned with regulatory requirements. 2. Train employees: Provide comprehensive training to employees on the CAPA process, including how to identify and report issues, and how to implement effective corrective and preventive actions. 3. Foster…
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…
1. Corrective action A systematic process undertaken to identify, analyze, and eliminate the root cause of a nonconformity or deviation in order to prevent its recurrence. 2. Preventive action Proactive measures taken to identify and eliminate potential causes of nonconformities or deviations before they occur. 3. Nonconformity Any deviation from established standards, procedures,…
