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Environmental Risk from Microbial Waste

Microbial waste includes any product that emanates from or has been used in tampering with microbes. This includes discarded cultures of microorganisms and infectious agents i.e. bacilli, discarded microbial specimens from pharmaceutical laboratories, pathological or research institutes, live and attenuated vaccines that have been discarded are also considered as waste and lastly, disposable Pet…

Periodic Review and Compliance in the Pharmaceutical Industry

Compliance in the pharmaceuticals is key to success, not only because it is required by law, but because the pharmaceuticals industry is considered one that doesn't allow mistakes. That is, if you make a faulty cell phone, your customers will ultimately get angry at you, but nobody gets hurt. With pharmaceuticals, any kind of error in the production can cause from nothing to death, and it is …

Self Inspection and Its Implementation in Pharmaceuticals

Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products.…

Basics of Cleaning Validation

Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.

Types of HVAC Systems

Introduction HVAC is a short form of Heating, Ventilation, and Air Conditioning. It is a system with the main purpose of making indoor surrounding more comfortable. HVAC systems are available in different types which come with unique specifications in order to suit your environment.

Types of HVAC systems There are basically four types of HVAC systems. They include:
Heating and Air Conditioning S…

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 the investigation is carried out to explain the reasons why it occurred.

Sanitation of Cleanroom Area in Pharmaceutical Manufacturing

It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. The area should be clean after a defined period as per standard operating procedure.

Computer System Validation in Pharmaceuticals

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity. Computer system validation also reduces long-term system and project costs by minimizing the cost of maintenance and rework.

GMP for Sterile Pharmaceutical Manufacturing

Maintenance of sterile area is a critical task because of air, as well as the personnel working in the sterile classified area, are the main source of the contamination. Following are some good manufacturing practice points those shall help in the maintenance of sterile area.

Tips to Develop Equipment Cleaning Procedure

A well-developed cleaning method is a primary requirement for the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.

Controlled area in Sterile Pharmaceutical Manufacturing

A controlled (classified) area is an enclosed environment or room with a flawless control over particulate contamination. More specifically, the areas have a controlled contamination level, which is specified regarding the number of particles for every cubic meter, for a specified particle size. The restricted areas are constructed with impeccable humidity, temperature and pressure control to min…

Various Types of Blenders and Their Purpose

A blender is a very important equipment in the pharmaceutical industry, as a medicine is manufactured by mixing a number of drugs and chemicals. This mixing is required to be undertaken in either dry or wet state depending upon the chemical composition and the reactions allowed. There are various types of blenders available in the industry, each one having its own purpose. Some of them are discus…

Possibilities of Contamination in Sterile Products

In pharmaceutical production, the term "sterile products" is usually used to describe parenteral preparations. These are products which are not meant to be administered via oral route or alimentary canal, so do not benefit from the protection of the immune system which the alimentary canal provides. Administration of these drugs is done directly to the blood stream or various body tissu…

COVID-19 SOP for Home in 15 Different Languages

Download and Print COVID-19 SOP for Home in your preferred language.
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Importance of Corrective and Preventive Action (CAPA)

Corrective Action and Preventive Action (CAPA) or what can be termed as corrective action are improvements imposed on an organizational process to eliminate undesirable situations and non-conformity. CAPA is characterized by a set of actions that regulations or laws require an organization to adhere to in procedures, documentation and manufacturing activities.

About the Author




Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.
Email: info@pharmaguideline.com

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