Out of Trend (OOT) Results in Pharmaceutical Quality Control

An analytical result does not necessarily have to exceed the specification limit in order to warrant concern regarding product quality. In the pharma industry, a result may be comfortably within the specification limits and yet evidence the occurrence of a change.

Such a situation is often referred to as being out of trend (OOT).

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Calibration Records in Pharmaceutical Manufacturing

Calibration records are critical quality records kept by pharmaceutical manufacturers. A long list of measuring instruments is frequently used in making decisions which can impact product quality.

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Documentation Gaps in Pharmaceutical GMP Systems

Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term is much broader. Properly organized documentation system enables a company to recreate any operations, monitor who performed a specific operation, trace ways of how this operation had been accomplished and assess if and how this operation was done in a valid…

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Documentation Practices That Impress Inspectors

During an inspection by regulatory authorities, various documentation reveal the working of a pharmaceutical facility. Although inspectors spend only few hours on the production site, they spend days scrutinizing batch reports, logbooks, evaluation documents and quality assurance documents. This documentation indicate whether processes have been implemented correctly and scientific rationale of d…

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Principle and Working of pH Meter | pH Probes Explained

The measurement of pH is critical analytical measurement in the pharma industry. Drug stability, solubility, bioavailability and therefore, product quality are all affected by the measured value (pH). In addition to how the pH affects product quality & can improve compliance with regulatory standards (and product consistency), it affects the raw material testing & the finished product tes…

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Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals

Pharmaceutical quality systems rely heavily on data integrity as a fundamental element. The accuracy, reliability, and completeness of data are mandatory requirements under regulatory expectations and will impact the safety of patients, the quality of product(s), and the reputation of the pharmaceutical industry as a whole.

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Best Practices for Isolator Technology in Pharmaceutical Manufacturing

Ensuring that sterile and contamination free environments are maintained has become even more critical for manufacturers of sterile pharmaceuticals today due to the need to control the potential for cross contamination in drug manufacturing which is particularly important when dealing with the production of sterile drug products, Biologics and High-potency compounds. One of the primary technologi…

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Tips for Hazardous Chemical Handling in Laboratories

Working with hazardous chemicals can have a serious risk to health if are used incorrectly and without the necessary training or safety precautions. In this post, I will give you guidance on how to work with these hazardous materials safely so that you can be confident working with these materials in your laboratory.

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Limitations and Advances in Dissolution Testing in Pharma

Dissolution testing has always been important for both gathering data about your form and also as part of product quality control. Dissolved drug products will vary in how quickly they release their active ingredient, so doing a dissolution test means you’ll understand how that form will affect the body after you take it. Many governments (U.S. FDA and EMA) examine how quickly a drug can dissolve…

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Components of Good Manufacturing Practices (GMP)

Pharmaceutical Quality Assurance is established through Good Manufacturing Practices (GMP). GMP provides a structured framework to ensure that all pharmaceutical products are manufactured reliably so that each product meets its specifications based on quality standards.

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Understanding GxP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations …

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21 CFR Part 11 Requirements for Laboratories

In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and stability chambers now generate electronic data that is processed digitally. This electronic system improved efficiency and traceability of the instruments and their data.

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How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals

Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products are manufactured in a sterile environment, but non-sterile products like tablets, capsules and liquid pharmaceutical products are manufactured in non-sterile manufacturing area.

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Best Practices in Pharmaceutical Microbiology Laboratory

Microbiology lab in the pharmaceutical industry helps to identify microbial contamination in pharmaceutical products. Critical analysis like environmental monitoring in clean rooms, sterility testing, microbial limit test and endotoxin testing are important analysis done in microbiology laboratory. Testing of microbial load in pharmaceutical products safeguards the patient's health against mi…

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Build a Quality Culture in Pharmaceuticals

Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the manufacturer towards the safety of the patients. It means defects in product quality may harm the user of the product.

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