Pharmaceutical Guidelines

Basics   of   Cleaning   Validation Cleaning method validation has its great importance in pharmaceutical manufacturing. An improper cleaning can produce harmful product. This article provides a brief introduction of whole process of cleaning validation. Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation. Cleaning validation is proof that the cleaning process is effective to removed all residues of the product that was manufactured, cleaning agents those were used during the cleaning process and prevents micro-organisms from developing. This process is done as a requirement of regulatory authorities. Manufacturing companies should not d...

FUNDAMENTALS OF MODERN UV-VISIBLE SPECTROSCOPY Principles and applications of UV-Visible Spectroscopy Basic Principles The electromagnetic spectrum Wavelength and frequency Origin of UV-visible spectra Transmittance and absorbance Derivative spectra Obtaining derivative spectra Applications Signal-to-noise Instrumental considerations  Qualitative Analysis Identification-spectra and structure Confirmation of identity Color Other qualitative information Protein and nucleic acid melting temperature  Enzyme activity Instrumental considerations Quantitative Analysis Beer's law Sample requirements Multicomponent analysis Principle of additivity Simple simultaneous equations method Least squares method Other method Sample requirements Instrumental requirements Indirect quantification Chemical derivatization Spectrophotometric titrations Enzyme kinetic assays This chapter outlines the basic theories and principles of UV-Visi...

High Performance Liquid Chromatography (HPLC) These are the articles on High Performance Liquid Chromatography used in quality control for analysis of pharmaceutical products, those are helpful to new as well as experienced pharmaceutical professionals. This page is updated regularly, therefore, don't forget to visit again. High-performance liquid chromatography  ( HPLC)  formerly referred to as  high-pressure liquid chromatography ) is a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. It relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material. Each component in the sample interacts slightly differently with the adsorbent material, causing different flow rates for the different components and leading to the separation of the components as they flow out of the column. HPLC has been used for man...

CAPA – Corrective Action Preventive Action – ⇓   Introduction to CAPA ⇓   What is CAPA ⇓   Why Implement CAPA ⇓   How to Implement CAPA ⇓   Learn More About CAPA Introduction to Corrective Action Preventive Action (CAPA) When illness strikes and we need medical attention, we put our trust in the medical products and care givers to provide relief. We expect the care we receive is without fault. Fortunately, failure is not experienced frequently in healthcare and medical devices. When failure does occur, we demand a rigorous process of investigation be initiated to identify why it occurred. Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. CAPA can be applied in many disciplines. A few of these disciplines are: Manufacturing ...

Following are the useful articles on quality control management and analysis of those are helpful to new as well as the experienced pharmaceuticals professional in quality improvement of product. This page is updated on a regular basis, therefore, don't forget to visit again.