PHARMA KING ACE

 In pharmaceutical production, change control is a crucial process that ensures any modifications to equipment, processes, or procedures are managed systematically and safely. Here are some examples of how change control is handled in the pharma industry: Equipment Change: When a pharmaceutical company decides to replace or upgrade a critical manufacturing equipment, a formal change control process is initiated. It involves assessing the impact of the change, conducting risk assessments, and ensuring proper validation of the new equipment before implementation. Process Change: If there is a need to modify a manufacturing process, change control is employed to evaluate the potential impact on product quality, safety, and efficacy. This process includes thorough documentation, testing, and validation to ensure the changes do not compromise product quality. Raw Material Change: When there is a need to switch or modify a raw material used in drug manufacturing, change control is applie...

  What is Data Integrity? Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate) was introduced in the 1990s for ensuring the pharma industry as a framework for data integrity and Good documentation practice (GDP). Then further introduced ALCOA plus is (Complete, Consistent, Enduring and Available) Currently used by the FDA, WHO, PIC/S, and GAMP. So overtime periods, data integrity concepts expand from ALCOA to ALCOA plus for ensuring data security and integrity ( data protection) are observed and maintained. ALCOA+ ALCOA has five basic principles (Attributable, Legible, Contemporaneous, Original, and Accurate) to stop data integr...

THIN LAYER CHROMATOGRAPHY Introduction Thin layer chromatography (TLC) is a technique in which a solute undergoes distribution between two phases, a stationary phase, acting through adsorption and a mobile phase in the form of liquid. The adsorbent is relatively thin, uniform layer of dry, finely powdered material applied to glass, plastic or metal sheet. Glass plates are most commonly used. Separation may also be achieved on the basis of partition or a combination of partition and adsorption, depending on a particular type of support, its preparation and its use with different solvent. Identification can be effected by observation of spots of identical Rf value and about equal magnitude obtained respectively, with an unknown and reference sample chromatograph on the same plate. Apparatus required Flat  glass plates of appropriate dimensions. b)  An aligning tray or plate surface on which the plates can be aligned and        ...