10+ Prologic First Interview Questions and Answers

IPQC tests for tablets/capsules in manufacturing and packing include appearance, weight variation, disintegration, dissolution, and content uniformity.

• Appearance inspection for color, shape, and size

• Weight variation testing to ensure consistency

• Disintegration testing to check if the tablet/capsule breaks down properly

• Dissolution testing to assess the release of the active ingredient

• Content uniformity testing to verify uniform distribution of the active ingredient

CQA stands for Critical Quality Attributes and CPP stands for Critical Process Parameters for tablets and capsules.

• CQA are the key physical, chemical, biological, or microbiological characteristics that must be within an appropriate limit, range, or distribution to ensure the desired product quality.

• CPP are the key process parameters that should be controlled within a narrow range or set points to ensure the product meets the desired quality attributes.

• Examples of CQA for tab...read more

Uniformity of weight is a measure of the consistency of weight among individual dosage units in a batch of pharmaceutical products.

• It is a requirement for pharmaceutical products as per IP/BP/USP standards.

• It ensures that each dosage unit contains the same amount of active ingredient.

• It is determined by weighing a sample of dosage units and calculating the average weight.

• If the weight of individual dosage units varies beyond a certain limit, it indicates poor uniformity of we...read more

Method validation is a process to confirm that an analytical method is suitable for its intended use.

• Define the purpose and scope of the method

• Select appropriate validation characteristics

• Develop a validation plan

• Execute the plan and document the results

• Evaluate the results and determine if the method is suitable for use

Executed BMR BpR is submitted in the manufacturing section of the dossier.

• BMR (Batch Manufacturing Record) and BpR (Batch Packaging Record) are important documents in the manufacturing process.

• They contain detailed information about the manufacturing and packaging process of a drug product.

• The executed BMR BpR is submitted in the manufacturing section of the dossier.

• This section includes information about the manufacturing process, quality control, and validation of the produ...read more

QMS process involves planning, execution, monitoring, and improvement of quality systems. OOS investigation involves identifying root cause of out-of-specification results.

• QMS process includes defining quality policies and objectives, identifying processes and resources, implementing controls, and monitoring performance.

• OOS investigation involves documenting the event, identifying the root cause, implementing corrective actions, and verifying effectiveness.

• Examples of OOS inv...read more

Selection of dies in PV sampling is based on various factors such as particle size, solubility, and stability.

• Particle size of the drug substance should be considered while selecting the die size.

• Solubility of the drug substance in the solvent used for the PV sampling should also be taken into account.

• Stability of the drug substance under the conditions of the PV sampling should be evaluated.

• The die should be able to produce pellets of uniform size and shape.

• Examples of commo...read more

Stratified sampling is a sampling technique where the population is divided into subgroups and a sample is taken from each subgroup.

• It ensures that each subgroup is represented in the sample

• It is useful when the population has distinct subgroups with different characteristics

• It increases the precision of the sample

• Example: Dividing a city's population into age groups and taking a sample from each group

Process validation types include prospective, retrospective, and concurrent validation.

• Prospective validation involves establishing specifications and procedures before production.

• Retrospective validation involves reviewing historical data to verify processes were consistently in control.

• Concurrent validation involves monitoring and evaluating processes during production.

• Examples: Prospective validation - setting up new equipment. Retrospective validation - reviewing past pro...read more

P.7 SECTION contains information about a specific topic or theme.

• P.7 SECTION is a section in a document or book that focuses on a particular subject or idea.

• It may contain detailed information, analysis, or discussion about the topic.

• Examples of P.7 SECTIONs include chapters in a book, sections in a report, or articles in a magazine.

• The content of P.7 SECTIONs can vary widely depending on the context and purpose of the document.

The number of samples analyzed per day varies depending on the workload and complexity of the samples.

• The number of samples analyzed per day can range from 50 to 200, depending on the size of the laboratory and the efficiency of the processes.

• Factors such as the type of analysis required, equipment availability, and staff expertise can also impact the number of samples analyzed per day.

• For example, in a high-throughput laboratory, the number of samples analyzed per day can be...read more

Quality assurance is the process of ensuring that products or services meet the desired level of quality.

• It involves creating and implementing quality control procedures

• It ensures that products or services meet customer expectations

• It involves continuous monitoring and improvement of processes

• Examples include conducting inspections, testing products, and analyzing data

• It is important for maintaining customer satisfaction and brand reputation

Change control is a process to manage changes in a controlled and systematic manner.

• It involves documenting and reviewing proposed changes

• Assessing the impact of changes on quality, safety, and efficacy

• Implementing changes in a controlled manner

• Ensuring that changes are communicated to relevant stakeholders

• Examples include changes to manufacturing processes, equipment, or specifications

Gas chromatography (GC) is a technique used to separate and analyze compounds in a mixture based on their volatility.

• GC relies on the principle of separating compounds based on their partitioning between a stationary phase and a mobile phase.

• Compounds with higher volatility will travel through the column faster and be detected earlier.

• GC is commonly used in the analysis of organic compounds, such as in drug testing or environmental monitoring.

• The output of a GC analysis is a ...read more

Glass packaging is commonly used in the pharmaceutical industry due to its ability to protect the contents from contamination and maintain product integrity.

• Glass packaging is preferred in the pharmaceutical industry because it is impermeable, non-reactive, and tamper-evident.

• Glass containers are also recyclable and environmentally friendly.

• Examples of glass packaging in pharma include vials, ampoules, and bottles for medications.