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 technique is used in pharmaceutical industries for research and testing purpo…
HPLC technique is used in pharmaceutical industries for research and testing purpo…
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.
Basic Requirements for Process Validation Exercise
Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at the lowest possible cost. In order to maintain the quality of a drug product and to ensure its safety, process validation has to be done. It is the essential …
Implementation of Six Sigma in the Pharmaceutical Industry
Pharmaceutical companies are facing many challenges in the market where increased competition and rising cost of materials eat into their profit margins. The industry is also very competitive and each player is looking to develop the most effective product in the market. As a result, the players op…
Lean Six Sigma Concept
Lean Six Sigma (LSS) is a combination of two processes that were initially applied separately to improve business efficiency and effectiveness. In a nutshell, the lean methodology is aimed at reducing or totally eliminating steps that do not add value in a manufacturing process and six sigma is a d…
CAPA and Its Proper Implementation
When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical care we receive is not faulty. It is so fortunate that failure is not frequently experienced in medical devices and healthcare. Oftenly failure can occur, and th…
