QA

Beyond Human Error | A Framework for Error Prevention and Mitigation
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Beyond Human Error | A Framework for Error Prevention and Mitigation

Errors are not a reflection of individual incompetence but a result of complex interactions between human factors, system design, & environmental influences. We must abandon the naïve belief that BETTER TRAINING will MAGICALLY ERASE ERRORS and instead embrace a holistic approach. The CAPA framework focuses on both PREVENTION and REACTION to errors: PREVENTION: BUILDING A…

Paperless Documentation in Pharmaceutical Industry

Paperless Documentation in Pharmaceutical Industry

 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…

In-Process Control Procedure in Pharmaceutical Industry

In-Process Control Procedure in Pharmaceutical Industry

 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…

Difference Between Regulatory affairs (RA) and Quality Assurance (QA)

Difference Between Regulatory affairs (RA) and Quality Assurance (QA)

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)?…

Interview Questions and Answers on IPQA

Interview Questions and Answers on IPQA

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….

Out of Specification (OOS) in Pharmaceutical Industry
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Out of Specification (OOS) in Pharmaceutical Industry

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…

Out of Trend (OOT) in Pharmaceutical Industry
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Out of Trend (OOT) in Pharmaceutical Industry

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…

25 Tips on CAPA in Pharmaceutical Industry

25 Tips on CAPA in Pharmaceutical Industry

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…