CAPA system enables organizations to address deviations and prevent recurrence to maintain product quality and regulatory compliance. Regulatory Requirements For Complaints and Recalls, requires a formal CAPA system for managing complaints and recalls to prevent recurrence Key Steps of CAPA Identification Evaluation Investigation Action Plan Implementation Verification & Effectiveness Check Closure Roles and Responsibilities Best…
In highly regulated environments, Change Control is vital for ensuring product quality and compliance with stringent regulations. Regulatory Rquirements FDA: EMA: ICH Q10: Types of Changes: Classification of Changes: Key Components of Change Control: Roles and Responsibilities: Best Practices: Read also: Resource Person: Alaaeldin Rashad
Quality excellence is the commitment to consistently meet standards by continuously improving processes, reducing errors, and delivering high-quality products to ensure patient safety, regulatory compliance, and operational efficiency. However, achieving quality excellence doesn’t always require major overhauls; small, strategic adjustments can make a powerful impact. Here are some actionable tips to boost quality performance today!…
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…
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….
