Pharmaceutical products need to follow a set of standards as a means of assurance of quality. Such a standard is validation, whether process or product validation, it is well known that the validation is made as an essential building block of good manufacturing practices (GMP) or a guideline for go…
Quality Manual and Quality Policy
The pharmaceutical industry is one of the fastest growing and sensitive sector dealing with medicins, patients, medicinal drugs and pharmacists. It needs to be handled with care to avoid the risk for the people living at stake. Thus the rules and regulations governing the operations within the phar…
Difference between Generic and Branded Medicines
A lot of persons have misperceptions regarding the quality of the generic and branded medicines. Generic and branded medicines both are prescribed by the doctors. Both of these medicines have the same drug but both have some difference in other ingredients.
Difference Between HEPA and ULPA Filters
The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are d…
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 elec…
Quality Metrics for Pharmaceutical Manufacturing
Quality metrics are the essential components of effective and efficient quality management plans in pharmaceuticals. They are the measurements used to ensure that the customers in the pharmaceutical industry receive acceptable deliverables or products. They are useful in translating the needs of th…
Best Communication Skills for Managers
The term communication is derived from "communicate" and is a way in which information is passed from one person to the other. Management has a key role in an organization. For an organization to perform well there should be a good culture and relationship that is well natured and well ke…
Different Types of Glass Containers used in Pharmaceuticals
Glass containers are often used in pharmaceuticals because they offer some important benefits that other materials don’t offer. They are formed by blowing, drawing, pressing, and casting. Some advantages of glass containers are there that make them fantastic option for pharmaceutical uses.
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 suit…
ALCOA to ALCOA Plus for Data Integrity
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
System Suitability in HPLC Analysis
HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture. In the HPLC technique, a liquid sample is passed over an absorbent material to test its efficacy.
HPLC chromatography technique is used in pharmaceutical industries for research an…
HPLC chromatography technique is used in pharmaceutical industries for research an…
Re-validation of Purified Water System
Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals. Due to an increase of micro-organisms in water during distribution, purification and storage; constant control of microbiological quality, inorganic and orga…
Visual Inspection of Light Sensitive Products
The pharmaceutical industry is dynamic by nature. Products in this industry are in a constant state of improvement and analysis. To keep the industry standards high, pharmaceutical products must be constantly checked for quality. One such area involves the visual inspection of light-sensitive produ…
Difference Between Aseptic and Sterile Conditions
The difference between "aseptic" and "sterile" is not always properly understood. These terms, which can be obviously used in a medical setting, also apply to the safekeeping of food and other perishable goods that can be attacked by bacteria, fungi or viruses. In a pharmaceutic…
Difference between Recall and Mock Recall
Any product which is manufactured on a large scale sometimes has to go through the process of recall and mock recall. To some people, these two terms seem to be really confusing or some people don't even know the meanings of them.
