Pharma Blog
Prediabetes Management Guidelines
Prediabetes is a health condition where the blood sugar levels are higher than normal, but not high enough yet to be diagnosed as type 2 diabetes. It is an intermediate stage between normal glucose regulation and diabetes, affects 1 in 3 adults in the US and approximately 720 million individuals ... Read More
Best Practices to control N-Nitrosamine Impurities
N-Nitrosamine impurities are a major concern for pharmaceutical industry. Because it is regulatory requirement to control the nitrosamine impurities in human drugs. In this article we are sharing 10 best practices to control the nitrosamine impurites. Use high-quality raw materials: The quality of raw materials used in the manufacturing process ... Read More
Change Control in Pharmaceutical Industry
Change Control is an important process within a Pharmaceutical Quality System. It involves providing justification for changes. A Pharmaceutical Quality System should enable continual improvement and facilitate change. It should include arrangements for the prospective evaluation of planned changes and approval prior to implementation. There should be checks that the ... Read More
Frequently Asked Questions on Data Integrity
This article contains a collection of frequently asked questions that have been submitted by the industry to the APIC DI taskforce. Which is divided into following sections: Q1. What is the difference between a digital and an e-signature? A digital signature is attached to an electronic file and not maintained ... Read More
Types of Dosage Forms with Examples
Pharmaceutical dosage form is consisting of drug substance(s) and/or excipient(s) to facilitate dosing of the content of the drug product to the patient. As per USP, there are several types of dosage form exist in pharmaceutics. AerosolsExamples: Ipratropium bromide (MDI), Salbutamol (DPI) CapsulesExamples: Flucloxacillin Sodium Capsule, Vitamin D3 Capsule, Vitamin-E ... Read More
Product Quality Test for Inhalation and Nasal Drug Products
Inhalation drug products deliver drugs into the lungs by oral inhalation and include inhalation aerosols, inhalation powders, inhalation sprays, inhalation solutions, inhalation suspensions, solutions for inhalation, and drugs for inhalation solutions dosage forms. Nasal drug products deliver drugs into the nasal cavity and include nasal sprays, nasal solutions, nasal aerosols, ... Read More
Product Quality Tests for Mucosal Drug Products
The mucosal route of drug administration is subdivided into seven membrane surfaces for the purposes of taxonomic distinction of dosage forms by route of administration. These membrane surfaces are characterized as otic, ophthalmic, nasal, oropharyngeal, urethral, vaginal, and rectal. In this article we provides product quality tests that are generally ... Read More
Product Quality Tests for Injections and Implanted Drug Products
Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either immediate- or ... Read More
Product Quality Tests for Topical and Transdermal Drug Products
Topically applied drug products fall into two general categories: (1) those applied to achieve local action and (2) those applied to achieve systemic effects after absorption through the skin into the blood circulation. They include, but are not restricted to creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, solutions, ... Read More
Drug Product Quality Tests and Performance Tests for Oral Dosage Form
Oral drug products fall into two main categories: solids and liquids. Solid oral drug products include but are not restricted to capsules, tablets, granules, and powders. Similarly, liquid oral drug products include but are not restricted to solutions, suspensions, and emulsions. Drug Product Quality Test Drug product quality tests for ... Read More
Pharmaceutical Tablet Preparation Process
Most compacted (compressed) tablets consist of the drug substance(s) and a number of excipients. These excipients may include fillers (diluents), binders, disintegrating agents, lubricants, and glidants. Approved FD&C and D&C dyes or lakes, flavors, and sweetening agents also may be present. Tablets are prepared from formulations that have been processed ... Read More