Glycerin: Properties, Applications, and Benefits Glycerin, also known as glycerol or glycerine, is a versatile and widely used chemical compound with a range of applications in various industries. It is a colorless, odorless, and viscous liquid that has gained popularity due to its unique properties and beneficial characteristics. In this …

Sorbitol Solution: Properties, Uses, and Applications Sorbitol solution, also known as sorbitol syrup, is a versatile and widely used sweetener and humectant in the food, pharmaceutical, and cosmetic industries. It is a clear, colorless liquid with a sweet taste and a range of beneficial properties. In this blog post, we …

Fumigation Fumigation is a method of spraying chemicals (fumigants) in the form of fine mist or vapors in the area (confined space) to reduce the bioburden of the area the Fumigant is a chemical substance which is having bactericidal, fungicidal & sporicidal activity at a defined concentration level. Gaseous decontaminants …

QUALITY MANAGEMENT SYSTEMS IN PHARMA A QUALITY MANAGEMENT SYSTEM IN PHARMA (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A Quality Management system in Pharma helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its …

GEMCITABINE INJECTION Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine …

Operational qualification protocol cum report shall consist of minimum contents but not limited to. Overview Purpose Background Responsibility Requalification System Description HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Deficiency (if any) and …

Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description FBD Machine Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency …

Performance qualification protocol cum report shall consist of minimum contents but  not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and …

Cleaning in Place or CIP systems CIP systems -The cleaning and sanitary aspects of manufacturing drug products are of extreme importance. The pharmaceutical industry must meet high hygienic standards to avoid a product’s degradation and contamination during manufacturing & packing and Area cleaning must be carried out quickly and thoroughly. The …

Sanitizing the clean rooms  PURPOSE: To lay down the procedure for sanitizing the clean rooms in normal operation and during various interruptions to make the clean area free from microbial & particle load. RESPONSIBILITY: Concern Department Person For the preparation of the Sanitization Solution. Production  Person To ensure the sanitization process. …

Operation & time verification of digital clock Digital Clock: A digital clock is a type of clock that displays the time digitally (i.e. in numerals or other symbols) as opposed to an analogue clock. Digital clocks are often associated with electronic drives but the “digital” description refers only to the …

The compressed air system in Pharma The Moisture free Compressed Air system comprises of state-of-the-art Vertical single cylinder reciprocating air-cooled compressor with a “V” Belt arrangement, starter cum control panel, safety devices, interconnecting piping, cabling, etc. and accessories duly mounted on a rigid steel deck. These packages are provided with …

Market Complaint -Stages of Handling A market/consumer complaint is a notification that a product is in commercial distribution (which also includes a physician sample). it May be in violation of the laws or regulations administered by the FDA (Drug Control Authority) or May have caused an illness, injury, or death …

Working Principle of Auto Coater Machine The film to be coated on the tablet is in liquid form before the process is started so the liquid is filled in the solution tank. The liquid is stirred well in the solution tank and then pumped into the coating pan. The coating …

QUALITY BY DESIGN AND SCALE – UP Unit operations are the individual basic steps in a process that when linked together define the process train and result in the final product. In practice, a unit operation is defined as an individual step that is carried out on one piece of …

Retrospective Validation The retrospective validation – to establish manufacturing procedures for products that are considered stable and resource limitations, prospective validation programs cannot be possible. Before initiation of retrospective validation, the numerical in-process and end-product test data of historic production batches are considered for statistical analysis, and the equipment, facilities, …

Reprocessing of non-confirming products (Formulation) To establish a procedure for Reprocessing non-confirming products (formulation). SCOPE: This SOP is applicable to all sections of the formulation. RESPONSIBILITY: Department in charge – Implementation of SOP & Documentation. Quality Assurance Person – To verify & monitor the activities as per SOP. R&D Person – Clearance from R&D …

Accident Management To establish procedures to be followed at the time of any accident during production operation. RESPONSIBILITY: Department in charge –Implementation of SOP & Documentation. Production Supervisor  (Present at the time of the accident) – To take the necessary action as per SOP. S&E Person – Clearance from S&E aspects. ACCOUNTABILITY: Production HEAD …

Quality Excellence & Quality Culture Check Addressing the sources of variability and defects is critically important when the failure rate is excessive or warranty obligations hurt profitability. The Quality Excellence Program helps business leaders, quality managers, and functional specialists to systematically improve process capability and consistently meet customer requirements at the lowest non-performance …

ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) This Annual product Quality review should be conducted with the objective of verifying the repeatability of existing processes, the appropriateness of current specifications for raw materials and finished products, identifying any trends and identifying any improvements to products and processes. It …