April 2024 - Industrial Pharmacist

Technology Transfer in Pharmaceutical Industry

Byipharmacist April 26, 2024September 7, 2024

Technology transfer significantly impacts the pharmaceutical industry in various ways: Innovation And Development: It allows companies to access cutting-edge technologies, research, and expertise from other organizations or institutions. This facilitates the development of new drugs, formulations, and manufacturing processes, leading to enhanced therapeutic options for patients. Cost-Effective Manufacturing: Technology transfer enables the adoption of…

Purifed Water System

Types of Water Used in Pharmaceutical Industry

Byipharmacist April 23, 2024March 29, 2025

A. Bulk Forms: which are typically produced on site where they are used. a. Purified Water (PW): Typically processed through 2 stages that treat the feed water: 1. Pretreatment which modifies the water quality to reduce or eliminate: suspended solids, hardness, metals, organics/TOC, fouling/scaling of downstream components, and disinfectants (chlorine/chloramines) that can be harmful…

Microbiology

What Type of Bacteria have Bacterial Endotoxin?

Byipharmacist April 19, 2024September 7, 2024

Bacterial endotoxin is a lipopolysaccharide (LPS) that is part of the membrane of gram-negative organisms. LPS activates immunity (by stimulating the production of cytokines and the expression of costimulatory molecules), which is a good thing. However, LPS also plays an important role in a bunch of bad things: septic shock, DIC (disseminated intravascular coagulation),…

Stability

Storage Condition of Pharmaceutical Products

Byipharmacist April 19, 2024September 7, 2024

The European Pharmacopoeia (Pharm. Eur.) gives some hints in chapter 1.2 (Other provisions applying to general chapters and monographs) with referring to analytical procedures: There are also some definitions in the WHO Guidance: Ambient temperature: Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. …

IPQC

In-Process Control Procedure in Pharmaceutical Industry

Byipharmacist April 17, 2024September 7, 2024

These are checks that are carried out before the manufacturing process is completed. The function of in-process controls is monitoring in order to comply with the specifications .It may include control of equipment and environment too. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing…

Microbiology

Why Do You Store Water Samples 2-8°C for Microbiological Analysis?

Byipharmacist April 16, 2024September 7, 2024

Microbiological water analysis estimates the number of bacteria present and identifies microorganisms. The microbial population in a water sample can change over time, which can lead to inaccurate assessments of water quality. Therefore, it is recommended that water samples be transported and analyzed within six hours. It is dependent on your validation research of…

FDA

FDA Recall Classification System

Byipharmacist April 2, 2024September 7, 2024

A recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which it would initiate legal action (e.g., seizure). Recall Classification Recall Classification is the numerical designation, i.e., I, II, or III, assigned by the FDA to a…

Analytical Development

Analytical Test Method Validation and Verification

Byipharmacist April 1, 2024September 7, 2024

Pre-Validation Requirements: Specificity: Linearity and Range: Accuracy and Precision: Robustness: Limit of Detection & Quantitation: System Suitability: Observations and Deviations: Analytical test method validation is a cornerstone of scientific accuracy and precision. Read also: