Pharmaceutical Guidelines : Total Pharmaceutical Solution

Pharmaceutical Guidelines

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 …

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…

Data Integrity as per 21 CFR Rules

Meaning of Data Integrity If you have been in the pharmaceutical industry for some time, you may have realized that protection of data from accidental/intentional modification, distortion, or deletion is the key to maintaining reliable health records which comply with the laid down regulations.

How Does Quality Cost Less in Long Term?

Have you ever wondered why high-quality products or goods last longer than the low-quality ones? Do you know the reason why the rich buy quality products and still remain rich? Have you ever thought of internalizing the saying "cheap is expensive"? Well, in this article you will be able t…

Why do HEPA Filters have 0.3 Micron Pore Size?

HEPA or High-Efficiency Particle Air filters are an essential part of the pharmaceutical and healthcare industries, where sterile environments are mandatory. Particles that cannot be seen by the naked human eye fill the air. These minute particles can cause the development of problems when working …

Why do We Expose Media Plates for 4 Hours in Cleanroom Areas?

A media plate, also known as a settle plate is basically a Petri dish that contains agar medium which acts as a growth medium for microorganisms. It is commonly used in pharmaceutical companies to assess the level of microorganisms in their clean rooms in order to maintain a clean environment.

Difference Between Disinfectants and Antiseptics

Disinfectant and antiseptics are widely used for cleaning in both health care settings and also in homes. These products contain various chemical components, a majority of which have been used as cleaning agents for ages. It's a fact that they are both used for destroying disease-causing microo…

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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