Good Clinical Practice and reports are related to clinical trials. The biggest ethical factor with clinical trials is the fact that the research is conducted on human subjects. GCP is an international standard concerning clinical trials and their proper implementation. GCP defines all aspects of cl…
Working of an Effluent Treatment Plant
Water is an essential part of manufacturing industry processes and domestic use. Water is used as a coolant, solvent or in many other chemical based reactions in companies.
After the manufacturing process is completed, wastewater is produced as a byproduct. This wastewater is then called effluent. …
After the manufacturing process is completed, wastewater is produced as a byproduct. This wastewater is then called effluent. …
Data Integrity Survey Results
We had conducted a data integrity survey that has amazing results. 3360 visitors of pharmaguideline.com participated in this data integrity survey and 87 % of them were from India. There were 8 simple questions regarding data integrity. Questions had options to select and all were mandatory to answ…
Quality System in Pharmaceuticals
Quality System in Pharmaceuticals or other words quality assurance is a dynamic process of understanding the regulations in this industry. The drugs that are taken to the consumers need to be safe and not cause long term effects on the one taking them.
Gap Analysis for Regulatory Compliance
If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.
Why Cold Chain Logistics are Required in Pharmaceuticals?
Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceutical logistics, however, for much of the decades, has been associated heavily with the food industry and less with the pharmaceutics. The introduction of new ty…
Quality Inspection in Pharmaceuticals
In pharmaceuticals, quality inspection involves a complete assessment and testing of medicinal products to ensure that they meet the required standards. It involves a number of actions taken place as discussed here.
Principles of Data Integrity
Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious consequences. Data integrity is defined as maintenance and assurance of data consistency and accuracy throughout its life-cycle. Keeping data consistent (unch…
Common Technical Document (CTD) for Dossiers
Common Technical Documents or CTDs are critical sets of information of a new drug that comprise the application dossier. The application dossier is then submitted for the purpose of obtaining approval by regional regulatory authorities before the drug can undergo clinical trials and subsequently be…
How to Care for pH Meter Electrodes
pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half-cells built inside the electrodes. These half-cells are coated with silver chloride or AgCl.
Role of Regulatory Affairs in Pharmaceuticals
Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers t…
Causes and Remedies of Picking in Tablet Manufacturing
In the pharmaceutical world, tablet picking refers to when a portion of the material in a tablet is removed. In most cases, picking occurs on the upper side of the tablet as opposed to the lower side. Tablet formation should meet various conditions; lubrication, heating, and cooling. These activiti…
Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) refers to a type of data submitted to the U.S. Food and Drug Administration (FDA) for the purposes of reviewing and approving potential generic drug product. Once the FDA approves the submitted drug, the applicant is allowed to manufacture the generic drug…
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.
