Validation in the pharmaceutical industry involves multiple departments working together. Quality Assurance (QA), Quality Control (QC), Production and Engineering all add their own knowledge to ensure the validation of processes, instruments, services, tests, etc. The responsibilities for validation must be laid out in the standard operating procedure, description of the validation process and re…
Showing posts with label Quality Control. Show all posts
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).
Such a situation is often referred to as being out of trend (OOT).
Handling Out of Expectation (OOE) Results in Pharmaceuticals
Not every problem with quality in pharmaceutical production is an OOS situation. There are plenty of cases when testing gives results in compliance with specifications but at the same time differing significantly from the past records of results or from expected performance. Such contradictions are known as OOE results.
Steps to Calculate MACO for Cleaning Validation in Pharmaceuticals
Cleaning validation is one of the most studied and analyzed processes during the pharmaceutical inspections since it demonstrates that the cleaning of production equipment can be performed with high quality and with full assurance that there would be no cross-contamination. While visual inspection of surface cleanliness is crucial, authorities also require companies to define the maximum allowabl…
Validation of Dissolution Methods in Pharmaceutical Analysis
Dissolution testing is recognized as one of the primary quality control tests for solid dosage forms. It shows how quickly and how much of the active ingredient (API) can be released from the tablets or capsules in the specified dissolving media. As a result, since the dissolution characteristics have a direct impact on drug release and thus bioavailability, the importance of this test is acknowl…
Common Audit Findings in Analytical Method Validation
Analytical method validation establishes documentation for how an analytical test procedure is adequate for meeting its intended use. When the test will be performed for assays, impurities, dissolution, residual solvents, microbiology, or cleaning validation samples, the reliability of the method will directly impact the quality determination regarding the product. Once a method has been validate…
Stability Study Failures and Investigations in Pharmaceuticals
Stability studies are extremely important scientific and regulatory functions in the pharmaceutical industry because they define your product's shelf life, recommend appropriate storage conditions, define packaging options and validate your product's quality from the initial stages of development through the final production of the product. When stability studies fail, the consequences ca…
Calibration of Class A and Class B Glassware in Pharmaceuticals
In pharmaceutical labs, having an accurate measurement is one of the key requirements to ensure that the different tasks required to correctly execute these pharmaceuticals are performed correctly, irrespective of whether it is preparing a buffer solution, diluting a sample, or conducting an Assay test; so much so that any slight mistakes made when measuring the volumetric quantity of some substa…
Change Control Impact on Validation Status in Pharmaceuticals
In the production of drugs, the validated state is important to ensure that products produced are of high quality, safe to use and in compliance with regulations set by the governing bodies. In the manufacturing area there will be changes. These changes could include equipment, process or system changes or material changes and will occur during production. If changes are not managed appropriately…
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…
GMP Requirements in Pharmaceuticals | Complete Compliance Guide
A key responsibility of the pharmaceutical sector is ensuring that they manufacture safe, effective and consistently produced medicines. Pharmaceutical companies achieve this through their compliance with Good Manufacturing Practices (GMP), which are regulatory frameworks, principles and guidelines used to regulate the manufacture, testing and distribution of drug products.
Out of Specification Investigation in Pharmaceuticals | Complete Guide
For the purposes of manufacturing pharmaceuticals and controlling quality of pharmaceutical products, it is imperative that products conform to pre-defined product specifications; as nonconforming product specifications could negatively affect the health and safety of patients as well as create non-compliance from a regulatory perspective. Occasionally, products that were manufactured fail to con…
Pharmaceutical Compliance and Product Quality | A Complete Guide
Compliance to regulatory requirements and quality assurance of drug products are the foundation of the global healthcare sector. All medications taken by patients have to be of assured safety, efficacy and consistency, which relies on strict compliance with established regulatory and quality system requirements.
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.
Various Shapes of Pharmaceutical Dosage Forms Importance
Pharmaceutical dosage forms can be defined by their appearance as much as (if not more than) their formulation. The shape of a dosage form has a significant impact on its function, manufacturability and acceptance by patients.
