ABHAHPLC Method Validation: Ensuring Accuracy and Reliability in Pharmaceutical Analysis High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique in the pharmaceutical industry for the analysis of drugs, impurities, and related substances. To ensure the accuracy and reliability of HPLC results, HPLC Method Validation is essential. This blog post provides a comprehensive overview of … Read more
Validation in Pharmaceuticals: Ensuring Quality, Safety, and Compliance Validation in Pharmaceuticals plays a critical role in the pharmaceutical industry by ensuring that processes, systems, and equipment consistently meet predefined requirements. It is a systematic approach to confirm and document that pharmaceutical products and processes meet the desired quality, safety, and efficacy standards. This blog post … Read more
API (Active Pharmaceutical Ingredients) and Excipients API: Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or another direct effect in the diagnosis, cure, … Read more
Usage of purified water at the user point OBJECTIVE: To define the procedure for the usage of purified water at the user’s point. SCOPE: This SOP is applicable to Tablet & Liquid section in the formulation. RESPONSIBILITY: Production Supervisor –Implementation of SOP. Workmen –To use purified water as per SOP. ACCOUNTABILITY: Production HEAD PROCEDURE: Open the tape of … Read more
Cleaning and sanitization of Flexible / braided tube/pipe OBJECTIVE: To establish a procedure for the use, cleaning, and sanitization of Flexible / braided tube/pipe. SCOPE: This SOP is applicable to all sections of the formulation unit. RESPONSIBILITY: Department in charge Implementation of SOP. Production Supervisor / Operator To use, clean & sanitize tube as per SOP. S&E … Read more
Pharmacokinetic Principles A drug should be able to reach its intended site of action after administration by some convenient route. In some cases, a chemical that is readily absorbed and distributed is administered and then converted to an active drug by biologic processes—inside the body. Such a chemical is called a prodrug. In only a … Read more
Pharmacodynamic Principles Most drugs must bind to a receptor to bring about an effect. However, at the molecular level, drug binding is only the first in what is often a complex sequence of steps. Types of Drug-Receptor Interactions Agonist drugs bind to and activate the receptor in some fashion, which directly or indirectly brings about … Read more
Water for Injection Water for Injection is sterile, nonpyrogenic, distilled water in a single-dose container for intravenous administration after the addition of a suitable solute. It may also be used as a dispensing container for diluent use. The pH is 5.5 (5.0 to 7.0) Water for Injection is used as an excipient in the production … Read more
UTILITY REQUIREMENTS FOR STERILE PRODUCT MANUFACTURING Any utility in direct product contact is subject to formal qualification through the confirmation of the quality of the delivered material at each use point. Water-for-injection (WFI) systems are considered the most critical of all, and the qualification period for WFI is the longest and may be as long as … Read more
FBD Machine Fluid bed dryer – FBD is a processing unit for the Drying of granulated materials for solid dosage forms in batch operations. The Fluid Bed Processor is designed for Drying, Granulating, and Coating. The processor runs in a batch operation. The heated inlet air homogeneously flows through the specially designed perforated sheet into … Read more