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…
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.
Determination of Hot and Cold Spot in Stability Chamber
Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.
Relative Response Factor (RRF) and its Calculation in HPLC Analysis
During the manufacturing process of active pharmaceutical ingredients, some unwanted substances are produced those are known as impurities. Some impurities are raised due to the degradation of the actual drug.
Steps for HPLC Method Development
Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step.
Steps for Analytical Method Development
Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified, separated and then quantified. Analytical method development is a process whose main purpose is to prove if any analytical method in the pharmaceutical industry is suitable to be used in the measurement of API.
Importance of Microbiological Analysis in Cleaning Method Validation
Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times during manufacturing and processing of pharmaceutical products, active residues are left on the equipment and it may cause contamination of the next product to be processed in the same equipment.
HPLC System Software Validation Plan
Introduction
Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
Steps for HPLC Method Validation
In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfacto…
Why is Analytical Method Validation Required?
Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable and produces consistent results. We can say that a validated analytical method produces reliable and authentic results.
Importance of Data Integrity in Pharmaceuticals
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
FDA New Data Integrity Guidelines: Highlights
Recently FDA observed a lot of cGMP violation in pharmaceutical manufacturing facilities worldwide. Most of the violations are related to data integrity. However 21 CFR part 211 and 212 explain the requirements of FDA data integrity but still, companies are facing problems in documentation and electronic record maintenance.
Data Integrity in Microbial Analysis
Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw information. Microbiological laboratories handle a lot of important data. In most of the occasions, those are the mix of quantitative as well as the qualitative data. Though protecting the pharmaceutical microbial data against vulnerability is much more importan…
Event Tree Analysis (ETA) in Pharmaceuticals
Event tree analysis (ETA) is a risk assessment technique that is used to sequence of events in a variety of industries. In pharmaceutical industry ETA is widely used to determine the root cause of any event. In this article, we will understand the uses of event tree analysis in pharmaceutical industry.
