Pharmaceutical Guidelines : Total Pharmaceutical Solution

Pharmaceutical Guidelines

Editable Pharmaceutical Documents in MS-Word Format



HPLC Column Void Volume

High-Performance Liquid Chromatography system is a test used mainly in analytical chemistry for identification, quantitative and control of related substances in chemical mixtures. The technique depends mainly on the uniqueness of the molecular weights and the polarities of elements. Compounded mix…

Regulatory Guidelines on Data Integrity

The pharmaceutical industry has been on the public eye for a long time now. People all over the world depend on quality medicine, safe to use drugs and above all, those that are effective in curing the disease they are meant to cure.

Insight on Data Integrity in Chromatography

The core objective of any analytical work is to produce reliable and scientifically accurate data. When the process is compromised the analyst is bound to obtain inaccurate results. This, in turn, affects the integrity of the data. Data integrity in the chromatography analysis is a key area of conc…

Steps to Minimize the Data Integrity Risk

Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for th…

Total Quality Management (TQM)

Total Quality Management is a managerial approach used by pharmaceutical manufacturers in ensuring pharmaceutical products meets the required quality with regard to their uses. It is a potentially beneficial approach to manufacturing pharmaceutical products, as it ensures they exceed customers'…

FDA Warning Letters for Cleaning Validation

Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections.

Identification of Worst Case in Cleaning Validation

It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the basis of the worst case. Worst case is the condition when it is difficult to clean the residues of the manufactured product from the equipment surface.

Build a Quality Culture in Pharmaceuticals

Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the manufacturer towards the safety of the patients. It means defects in product quality may harm the user of the product.

Control of Contamination at Different Manufacturing Stages

One of the most critical aspects of dosage form manufacture is the vigilance and care required ensuring the complete absence of any form of cross-contamination. Contamination may occur at any stage of the manufacturing process. Personnel, equipment, area and raw material all may have contamination …

Favourable Conditions for Microbial Growth in Cleanroom Area

In the pharmaceutical industry, the end is to produce a drug that will help humanity in either promotion of health status, amelioration of the disease condition or palliating a chronic illness. For this cause, the pharmaceutical companies provide for themselves a conducive place to make drugs. Thes…

Determination of Data Integrity Compliance in Pharmaceuticals

Data integrity is the principle of generating, maintaining and assuring the consistent accuracy and completeness of data in a company or manufacturing plant through the entire life cycle complying with the regulations set within the pharmaceutical industry by the Food and Drug Administration (FDA).…

Validation of Utility Systems in Pharmaceutical Facilities

This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acce…

Computerized System Validation Planning and Execution

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed.

How to Write a Validation Master Plan?

A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is …

Validation Program in Pharmaceutical Industries

Validation is defined as:
Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented …

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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