Showing posts with label Quality Control. Show all posts
Handling Out of Expectation (OOE) Results in Pharmaceuticals
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Not every problem with quality in pharmaceutical production is an OOS situation. There are plenty of cases when testing gives results in com...
Steps to Calculate MACO for Cleaning Validation in Pharmaceuticals
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Cleaning validation is one of the most studied and analyzed processes during the pharmaceutical inspections since it demonstrates that the c...
Validation of Dissolution Methods in Pharmaceutical Analysis
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Dissolution testing is recognized as one of the primary quality control tests for solid dosage forms. It shows how quickly and how much of t...
Common Audit Findings in Analytical Method Validation
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Analytical method validation establishes documentation for how an analytical test procedure is adequate for meeting its intended use. When t...
Stability Study Failures and Investigations in Pharmaceuticals
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Stability studies are extremely important scientific and regulatory functions in the pharmaceutical industry because they define your produc...
Calibration of Class A and Class B Glassware in Pharmaceuticals
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In pharmaceutical labs, having an accurate measurement is one of the key requirements to ensure that the different tasks required to correct...
Change Control Impact on Validation Status in Pharmaceuticals
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In the production of drugs, the validated state is important to ensure that products produced are of high quality, safe to use and in compli...
Principle and Working of pH Meter | pH Probes Explained
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The measurement of pH is critical analytical measurement in the pharma industry. Drug stability, solubility, bioavailability and therefore, ...
GMP Requirements in Pharmaceuticals | Complete Compliance Guide
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A key responsibility of the pharmaceutical sector is ensuring that they manufacture safe, effective and consistently produced medicines. Pha...
Out of Specification Investigation in Pharmaceuticals | Complete Guide
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For the purposes of manufacturing pharmaceuticals and controlling quality of pharmaceutical products, it is imperative that products conform...
Pharmaceutical Compliance and Product Quality | A Complete Guide
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Compliance to regulatory requirements and quality assurance of drug products are the foundation of the global healthcare sector. All medicat...
Tips for Hazardous Chemical Handling in Laboratories
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Working with hazardous chemicals can have a serious risk to health if are used incorrectly and without the necessary training or safety prec...
Various Shapes of Pharmaceutical Dosage Forms Importance
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Pharmaceutical dosage forms can be defined by their appearance as much as (if not more than) their formulation. The shape of a dosage form h...
Limitations and Advances in Dissolution Testing in Pharma
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Dissolution testing has always been important for both gathering data about your form and also as part of product quality control. Dissolved...
Non-Conformance in Pharmaceuticals and Prevention
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In the pharmaceutical industry, having the integrity of your product as a major objective is a mandatory requirement. All items produced sho...
Improving Quality Through Supplier Audits in Pharma
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The pharmaceutical industry establishes product quality from the time raw materials, components and services are provided to the manufacture...
Common Causes of Low Quality Products in Pharmaceuticals
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In pharmaceutical manufacturing maintenance of high product quality is a top priority. When products do not meet the required standards for ...
In-Process Control Methods for API Manufacturing Quality
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Precision, uniformity and adherence to stringent regulations are the requirements of drug manufacturing. Drugs are produced using active pha...
Ultrasonic Cleaning in Pharmaceuticals Process Guide
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Pharmaceutical cleaning is not only the best practice to keep your manufacturing operation clean. It is also a critical regulatory and quali...
User Requirement Specification (URS) in Pharmaceuticals
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The User Requirements Specification (URS) is the initial document that establishes the quality and regulatory compliance of all instruments,...
