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.
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.
