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.
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).…
