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Showing posts with the label Quality Assurance

IQ OQ PQ Full Form - Installation Qualification, Operational Qualification Performance Qualification

IQ stands for installation qualification, OQ for operational qualification, and PQ for performance qualification. IQ OQ PQ are three sequential activities that manufacturers carry out to validate their manufacturing processes. IQ ensures that equipment is installed correctly, OQ ensures that equipment operates as expected, and PQ ensures that equipment meets performance requirements.

What is the role of producer top management and QAS towards quality assurance in BRD?

 The role of producer top management and QAS towards quality assurance in BRD is to establish a clear quality assurance policy and objectives. They should also ensure that adequate resources are allocated to quality assurance activities and that these activities are carried out in a systematic and planned manner. Furthermore, they should monitor the effectiveness of quality assurance activities and take corrective action where necessary.

What questions are asked by managers of pharmaceutical companies of their quality assurance people?

 1. What quality assurance procedures does your company have in place? 2. How do you ensure that your products meet quality standards? 3. What are your procedures for investigating quality issues? 4. What quality metrics do you track? 5. How does your company handle non-conforming products? 6. What corrective and preventative actions have you taken in response to quality issues? 7. What trends are you seeing in your quality data? 8. How has your quality management system evolved over time? 9. What challenges do you face in maintaining quality standards? 10. What role do quality assurance personnel play in your company's operations?

Quality Audit

Quality Audit can be defined as systematic, independent and documented examination by quality auditor which may be internal or external. What is quality Audit? Quality Audit can be defined as Systematic, independent and Documented Examination. Why quality Audit is Required? The reasons quality audit is required are as follows , so let us check it out one by one. To ensure that quality systems are maintained. To achieve the consistency between manufacturing and testing facilities. To ensure the customers requirements are understood and met. To improve processes going on in the industry. Also done to reduce the risk of failure. Regulatory requirements and for Business benefits. To check the cGMP compliance with the company's standard procedure. Types of Audits Generally the audits are divided into major two types, 1) Internal Audits and 2) External Audits. Let us check it out one by one  and the importance of each audits and why is is performed.? Internal...

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