Pharma Blog
FDA Findings and Remedies on cGMP Violations
The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control ... Read More
Fentanyl Patches | Drug Digest
Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time (chronic pain) and who cannot be treated with other medications. Fentanyl is in a class of medications called narcotics. It works by changing the way the ... Read More
Different Types of Clinical Research Studies
Clinical research studies come in many different forms, each with its own purpose and unique approach. Let’s take a look at some of the most common types of studies: Prevention trials are like superheroes, working to prevent the development of a particular condition or disease. Researchers test a variety of ... Read More
Piperacillin and Tazobactam for Injection | Drug Digest
Piperacillin and Tazobactam for Injection is indicated for the treatment of patients with systemic and/or local bacterial infections, caused by piperacillin resistant, piperacillin/tazobactam susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: To reduce the development of drug resistant bacteria, Piperacillin and Tazobactam for Injection ... Read More
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: