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Pharmaceutical Guidelines

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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.
Download COVID-19 SOP for Home - English (India)
Download COVID-19 SOP for Home - English (World)
Download COVID-19 SOP for Home - Hindi
Download COVID-19 SOP for Home - Gujarati
Download COVID-19 SOP for Home - Marathi
Download COVID-19 SOP for Home - Tamil
Download COVID-19 SOP for Home - Telugu
Download COVID-19 SOP for Home - Bangla

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.

COVID-19 SOP for Home

1.0 Objective: To lay down the procedure for prevention from COVID-19 at home.
2.0 Scope: This procedure is applicable to the home of everyone.
3.0 Responsibility: Every member of the home.
4.0 Accountability: Housewife in the home.

Prevention of Microbial Contamination in Manufacturing

The quality and safety of pharmaceutical products should be a key concern to any manufacturer in order to take care of clients consuming the product as well as maintaining their brand name in the market. Therefore to prevent microbial contamination in pharmaceutical products, there are some key measures or considerations that a manufacturer needs to take care of.

Critical and Non-critical Areas in Pharmaceutical Manufacturing

Appropriate design, positioning and use of critical and non-critical areas in the pharmaceutical manufacturing process are among the key prerequisites for success in this industry. Critical areas include all areas in which any kind of sterile product (including both drugs and equipment) must be exposed to the sterile environment and where activities including sterilization, sterile filling and c…

Different Types of HPLC Detectors

HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column. They are capable of determining the identity and concentration of eluting compounds in the mobile phase. There are specific detectors which respond to a specific compound and their response is not dependent on mobile phase composition.

Concept of GxP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations…

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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