How to Measure Melting Point in Quality Control?
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How to Measure Melting Point in Quality Control?

Measuring the melting point of a substance is a critical quality control (QC) test in pharmaceuticals, as it helps to identify the substance and determine its purity. Here’s how melting point is typically measured in QC: Methods for Measuring Melting Point Equipment Used Procedure Calculations Reporting Results Regulatory Requirements Read also: Resource Person: Dhruv Jayswal

What is the Role of Antifoaming Agents in Dissolution Testing?

What is the Role of Antifoaming Agents in Dissolution Testing?

The dissolution medium contains a surfactant, like sodium lauryl sulfate (SLS) or Tween 80. The test begins smoothly, but soon enough, foam starts building up—slowly at first, then rising relentlessly. Before you know it, there’s foam all over the place, making sampling impossible and throwing your entire test off balance. Frustrating, right? The “Eureka” Moment!…

How Does Microbiology Contribute to Quality Assurance?
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How Does Microbiology Contribute to Quality Assurance?

Microbial Limit Testing Tests: Acceptance Limits: As per WHO and USP <61>: Sterility Testing Tests: Microorganisms Tested: Acceptance Limits: Endotoxin Testing (Bacterial Pyrogens) Tests: Microorganisms Tested: Acceptance Limits: Environmental Monitoring Tests: Microorganisms Tested: Acceptance Limits (as per WHO/GMP): Water Testing Tests: Microorganisms Tested: Acceptance Limits (WHO): Antimicrobial Effectiveness Testing (AET) Tests: Microorganisms Used: Acceptance Limits:…

Q&A Regarding Cleaning Validation in Pharmaceutical Manufacturing

Q&A Regarding Cleaning Validation in Pharmaceutical Manufacturing

Q. Why is cleaning validation important? Cleaning validation ensures: Q. Is cleaning validation required for dedicated equipment? Yes, as long as any piece of equipment or manufacturing system is used in the production, processing, packing, or holding of drug products, cleaning validation is required. Q. When is cleaning validation required? Q. What is the difference…

Frequently Asked Questions and Answers on Out of specification (OOS)

Frequently Asked Questions and Answers on Out of specification (OOS)

Q. Do we need to initiate an OOS investigation if OOS results are found during API Method Transfer? Ans: Yes, if it happens at the originating lab. If it happens at the receiving lab, handle it through a lab incident or deviation to identify the root cause as per in-house SOP; no OOS is needed….

Interview Questions and Answers on Computer System Validation

Interview Questions and Answers on Computer System Validation

Q. What is computer system validation and why is it important in regulated industries? Computer system validation is the process of ensuring that a computer system meets the requirements of a specific regulatory standard. It is important in regulated industries because it helps ensure data integrity, product quality, and patient safety. Q. What regulatory requirements…

Interview Questions and Answers on Supply Chain Management

Interview Questions and Answers on Supply Chain Management

Pharmaceutical Supply Chain Management is a core part of pharmaceutical industry. They maintain the inventory up-to-date as per company requirements. A list of common interview questions and answers on supply chain management are mentioned below: Q. What is supply chain planning? Supply chain planning involves the processes and strategies used to optimize the delivery of…

Interview Questions and Answers on Project Management in Pharma Industry

Interview Questions and Answers on Project Management in Pharma Industry

Nowadays project management is a crucial sector in pharma industries. A project manager can guide a project right way and can track all the activities from initiation to closing of the project. Here we mention few common interview questions for the candidates who are interested to get project manager role in a pharma industry: Q….

Pharmaceutical Material Management Interview Questions and Answers

Pharmaceutical Material Management Interview Questions and Answers

Q. What do you mean by Active Ingredient? Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, or to affect the structure or any function of the body of man or other animal, 21 CFR 210.3 (b)(7). Q. What do you mean by Inactive ingredient (Excipient)?…