Pharma Blog
Physicochemical Properties of Drugs
Physicochemical properties are all the physical and chemical properties of a drug, which are influence the drug performance or action. Various Physico-Chemical Properties of Drugs Thermodynamic properties Kinetic properties Spectroscopic properties Surface properties Mechanical properties Packing properties If a deficiency is detected, then the project team should decide on the ... Read More
Good Laboratory Practice in Microbiology Laboratory
Good microbiological laboratory practices (GMLP) are designed to protect both workers (i.e., lab staff, non-lab staff and researchers) and research material (i.e., organisms and equipment) in the microbiology laboratory. It consist of activities that depend on several principles: aseptic technique, control of media, control of test strains, operation and control ... Read More
Difference Between Quality Control (QC) and Quality Assurance (QA)
Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production ... Read More
In-Process Control Procedure in Pharmaceutical Industry
IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process monitoring in order to comply with the specifications. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, ... Read More
Clinical Pharmacy Standards of Practice
Clinical pharmacists are licensed pharmacists with specialized advanced education and training who provide comprehensive medication management and related care for patients in all health care settings. Clinical pharmacists also work in collaboration with other providers to deliver comprehensive medication management that optimizes patient outcomes. The clinical pharmacist’s standards of practice ... Read More
CAPA Process Steps in Pharmaceutical Industry
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources ... Read More
Difference Between Calibration and Qualification
A list of differences between calibration and qualification are mentioned below: Similarities Read also:
Coating Process in Pharmaceutical Industry
Although both sugar coating and film coating are utilized by a significant number of pharmaceutical companies worldwide, the film-coating process is the one most often preferred today. Film coating was formally introduced into the pharmaceutical industry in the middle of the last century. It should be noted that there has ... Read More
Frequently Asked Questions and Answers on cGMP
Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment. But no similar requirement exists for retaining what are intended to ... Read More
Subpart of 21 CFR Part 211
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. FDA 21 CFR Part 211 covers the areas for finished drug products, such as labeling, production processes, equipment management and ... Read More
ICH Quality (Q) Guidelines and Their Relevance to Pharmaceutical Manufacturing
In this article we discuss on ICH Quality (Q) Guidelines and their relevance to different phases of drug development and manufacturing. ICH Q1A(R2) – Stability Testing of New Drug Substances and Products This guideline provides recommendations on the stability testing of new drug substances and products, including the design of ... Read More