20+ Safiec - Safi Energy Company Interview Questions and Answers

Answering questions related to HPLC, disintegration, dissolution, Cu test, assay test, and HPLC troubleshooting.

• HPLC stands for High Performance Liquid Chromatography and is used to separate, identify, and quantify components in a mixture.

• Disintegration is the process of breaking down a tablet or capsule into smaller particles, while dissolution is the process of dissolving the drug substance in a solvent.

• Criteria of dissolution include the amount of drug substance dissolved,...read more

ALCOA and ALCOA plus are data integrity principles used in regulated industries.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA plus adds the principles of Complete, Consistent, Enduring, and Available.

• These principles ensure that data is reliable, traceable, and can be reproduced.

• They are commonly used in industries such as pharmaceuticals, biotech, and medical devices.

• Examples of ALCOA plus requirements include ensuring that data is bac...read more

GMP and cGMP, ALCOA +, 21 CFR, Validation of autoclave and lyophilization, Terminal sterilization.

• GMP (Good Manufacturing Practice) and cGMP (Current Good Manufacturing Practice) are guidelines for ensuring quality and safety in the manufacturing process of pharmaceuticals.

• ALCOA + stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. It is a set of principles for data integrity in the pharmaceutical industry.

• 21 CFR (Code of Federal Regulations) ...read more

NVPC limit varies by area classification, interventions during filling and area qualification process are crucial.

• NVPC limit is determined based on the classification of the area (e.g. Grade A, Grade B, Grade C)

• Interventions during filling process may include environmental monitoring, personnel training, and equipment validation

• Area qualification process involves assessing the cleanliness, air quality, and overall suitability of the area for its intended purpose

ALCOA+ is an extension of ALCOA, adding data integrity principles for electronic records.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA+ includes additional principles like Complete, Consistent, Enduring, and Available.

• ALCOA focuses on paper records, while ALCOA+ is tailored for electronic records.

• Ensuring data integrity is crucial in regulated industries like pharmaceuticals.

• ALCOA principles are essential for maintaining the quality and...read more

Karl Fischer titrator is used to determine the water content in a sample by titrating it with a Karl Fischer reagent.

• Karl Fischer titrator uses a Karl Fischer reagent which reacts with water to produce iodine.

• The iodine produced is then titrated with a standard solution of iodine to determine the water content.

• The endpoint of the titration is detected using a detection method such as potentiometry or colorimetry.

• The amount of titrant used in the reaction is directly proportio...read more

Alcoa's good manufacturing process focuses on quality control, efficiency, and continuous improvement.

• Alcoa emphasizes quality control to ensure products meet high standards

• Efficiency is a key focus to streamline production processes

• Continuous improvement is achieved through feedback, data analysis, and innovation

ALCOA and ALCOA+ are principles used in data integrity to ensure data is Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA+ includes the original ALCOA principles and adds the concepts of Complete, Consistent, Enduring, and Available.

• These principles are commonly used in industries such as pharmaceuticals, healthcare, and research to ensure data integrity and compliance.

• For exam...read more

21 CFR is a set of regulations issued by the US FDA to ensure the safety and effectiveness of drugs, medical devices, and food products.

• 21 CFR stands for Title 21 of the Code of Federal Regulations.

• It covers various aspects of product development, manufacturing, labeling, and marketing.

• Examples of regulations under 21 CFR include Good Manufacturing Practices (GMPs) for drugs and medical devices, and Nutrition Labeling and Education Act (NLEA) for food products.

• Compliance with...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data integrity ensures that data is accurate, consistent, and reliable.

• It involves maintaining the quality and reliability of data over time.

• Data integrity can be achieved through various methods such as encryption, checksums, and error detection codes.

• Examples of maintaining data integrity include regular backups, data validation checks, and access controls.

• Ensuring data inte...read more

Tracking and analyzing the performance of individuals in their working area compared to the planned targets for the year.

• Regularly review and update individual performance goals and targets

• Analyze the reasons for any variances between planned and actual performance

• Provide feedback and support to help individuals meet their targets

• Adjust goals and targets as needed based on performance trends

• Use data and metrics to track progress and make informed decisions

Area management in department involves overseeing and coordinating the operations of a specific geographical region within a department.

• Developing and implementing strategies to achieve departmental goals within the designated area

• Managing and supervising staff within the area

• Ensuring compliance with regulations and policies

• Monitoring and analyzing performance metrics to identify areas for improvement

• Collaborating with other departments and stakeholders to achieve common obje...read more

Cipla is a global pharmaceutical company based in India, known for its focus on affordable and accessible healthcare solutions.

• Cipla was founded in 1935 by Dr. K.A. Hamied in Mumbai, India.

• The company has a presence in over 80 countries and offers a wide range of pharmaceutical products.

• Cipla is known for its emphasis on research and development, with a focus on providing affordable medicines for various health conditions.

• The company has received several awards and recognitio...read more

BMR stands for Basal Metabolic Rate, which is the amount of energy expended while at rest.

• BMR is the number of calories your body needs to perform basic functions like breathing and circulation.

• Factors that affect BMR include age, gender, weight, and muscle mass.

• BMR can be calculated using equations like the Harris-Benedict equation or the Mifflin-St Jeor equation.

DI stands for Data Interpretation, it involves analyzing and interpreting data to extract meaningful insights.

• DI involves analyzing data sets to identify trends, patterns, and relationships.

• It helps in making informed decisions based on the data available.

• Examples of DI include creating charts, graphs, and reports to visualize data.

• DI is commonly used in business analytics, market research, and scientific studies.

Change control is a process used to ensure that changes to a system are implemented in a controlled and coordinated manner.

• Change control involves documenting proposed changes, assessing their impact, and obtaining approval before implementation.

• It helps prevent unauthorized changes, ensures proper testing and validation, and maintains system integrity.

• Examples include software updates, hardware upgrades, and process changes in a company's operations.

My procedure involves thorough planning, effective communication, delegation of tasks, monitoring progress, and making necessary adjustments.

• Thoroughly plan the project or task at hand

• Communicate effectively with team members and stakeholders

• Delegate tasks based on team members' strengths and expertise

• Monitor progress regularly and make adjustments as needed

• Ensure all deadlines are met and goals are achieved

ALCOA+ is a framework used in data integrity to ensure data is Attributable, Legible, Contemporaneous, Original, and Accurate, with the addition of the plus sign for additional requirements.

• ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, and the plus sign for additional requirements.

• It is commonly used in regulated industries such as pharmaceuticals and healthcare to ensure data integrity.

• Attributable means that all data should be traceable to it...read more

In process test is a test conducted during the manufacturing process to ensure quality and identify any issues before the final product is completed.

• In process tests are conducted at various stages of production to check for defects or deviations from standards.

• These tests help in identifying and addressing issues early on, reducing the chances of producing faulty products.

• Examples of in process tests include checking dimensions of components, conducting stress tests, and ins...read more

Spectroscopy is the study of the interaction between matter and electromagnetic radiation.

• It involves the measurement and analysis of the absorption, emission, or scattering of light or other forms of electromagnetic radiation.

• Spectroscopy is used in various fields such as chemistry, physics, astronomy, and environmental science.

• It helps identify and analyze the chemical composition, structure, and properties of substances.

• Examples include infrared spectroscopy, nuclear magne...read more

Change control is a process used to manage changes to a project or system in a controlled and systematic manner.

• Change control involves documenting, evaluating, approving, and implementing changes.

• It helps ensure that changes are necessary, beneficial, and do not negatively impact the project or system.

• Examples of change control include updating software, revising project plans, and modifying processes.

• It typically involves a change control board or committee to review and ap...read more

Tablets can be categorized into three types: standard tablets, convertible tablets, and rugged tablets.

• Standard tablets are the most common type and are designed for everyday use.

• Convertible tablets have a detachable keyboard and can be used as a laptop or tablet.

• Rugged tablets are built to withstand harsh environments and are often used in industries like construction and manufacturing.

• Examples of standard tablets include the iPad and Samsung Galaxy Tab.

• Examples of convertib...read more

Automation is the use of technology to perform tasks with minimal human intervention.

• Automation involves using machines, software, or other technology to carry out tasks that would otherwise be done by humans.

• Examples of automation include robotic process automation (RPA), automated assembly lines in manufacturing, and automated email marketing campaigns.

• Automation can increase efficiency, reduce errors, and free up human workers to focus on more complex tasks.

• Automation can ...read more

ICH guideline stability conditions outline the recommended storage and testing conditions for pharmaceutical products.

• ICH guidelines provide specific temperature and humidity conditions for stability testing

• Stability conditions vary based on the type of product (e.g. solid, liquid, semi-solid)

• Examples of stability conditions include long-term storage at 25°C/60% RH and accelerated testing at 40°C/75% RH