Difference between OOS and OOT
Difference between OOS and OOT
Out of Trend OOT in Pharma
Out of Trend (OOT) in the context of the pharmaceutical industry refers to a significant deviation or change observed in the trend or pattern of test results over time. Out-of-Trends analysis is an important aspect of quality control and is conducted to identify potential shifts in product quality or process performance. Key points about Out … Read more
Out of Specification OOS in pharma
Out of Specification (OOS) refers to a condition that occurs in the laboratory of a pharmaceutical plant when a sample, product, or critical parameter fails to meet predetermined specifications or acceptance criteria. It is a deviation from the established quality standards set for pharmaceutical products. OOS results indicate that the observed value or characteristic of … Read more
Management Review Meeting MRM in Pharma
The Management Review Meeting (MRM) in the pharmaceutical industry serves as a crucial platform for organizations to evaluate their overall performance, assess the effectiveness of their management systems, and chart a course for continuous improvement. With the complexities and regulatory demands unique to the pharmaceutical sector, the objectives of the MRM take on a specific … Read more
Quality Management Review System SOP QA-051
This Report shall include the following but not be limited to; Where QMR = Quality Management Review Report YY = Last two digits of the year in which the Quality Management meeting is performed. XXX = Sequential number, beginning from 001. RA : Regulatory Affair QA : Quality Assurance NA : Not … Read more
Good Engineering Practices (GEP) in Pharmaceutical Industry
The concept of Good Engineering Practices (GEP) encompasses a set of principles, methodologies, and guidelines that serve as a foundation for ensuring quality, safety, and efficiency in engineering processes across various industries. GEP provides a framework for professionals to follow standardized practices and procedures, promoting consistency, reliability, and compliance in their work. At its core, … Read more
Swab Analysis in Microbiology MB 053
Standard Operating Procedure for the Swab Analysis. SOP Version No. Change Control No. Reason for revision Effective Date 00 NA First issue REPORT OF ANALYSIS OF SWAB SAMPLE Sample Details : Name of Sample Batch No. Microbiology Ref. No. Date of Sampling Sample By Date of Testing Date … Read more
Difference between Fogging and Fumigation 2023
Fogging and Fumigation play vital roles In the pharmaceutical industry in maintaining a sterile and contamination-free environment. To achieve this, fumigation and fogging techniques play a critical role. In this article, we explore the significance of fumigation and fogging in pharmaceutical settings, highlighting their crucial contributions to ensuring product quality, safety, and regulatory compliance. fogging … Read more
Karl Fischer Calibration
The Karl Fischer Calibration & titrator is a crucial instrument in the field of analytical chemistry, specifically designed for the determination of moisture content in various substances. This sophisticated apparatus provides accurate and reliable results, making it indispensable in industries such as pharmaceuticals, food, and cosmetics. Operating the Karl Fischer titrator requires a systematic approach. … Read more
Insectocutor working principle 2023
Insect-o-cutor or Insectocutors, also known as electric insect traps or bug zappers, are innovative devices designed to attract and eliminate flying insects. They provide an effective means of controlling pests in various environments, including homes, commercial establishments, and outdoor spaces. The primary goal of insectocutors is to create a pest-free environment by attracting insects to … Read more