Pharma Digest
Objective of Data Management and Integrity in Pharmaceutical Industry
There are 20 main objective of data management and data integrity in pharmaceutical industry. Let’s check it out – 1. Ensure the accuracy and completeness of data. 2. Maintain data confidentiality and security. 3. Facilitate compliance with regulatory requirements. 4. Ensure consistency of data across different systems and platforms. 5. ... Read More
Types of Change Control in Pharmaceutical Industry
In pharma industry, any proposal for change requires evaluation of the change against the marketing authorization (MA) for the product, Good Manufacturing Practice (GMP) guidelines, and patient safety. Most importantly, consideration must be given to the impact of the change on the patient safety. This is the primary concern when ... Read More
Vendor Qualification in Pharmaceutical Industry
The primary step for Manufacturing is to ensure that API (Drug Substance) Vendor Qualification is complied to manufacture a FDF- Finished Dosage Form / Formulation (Drug Product) which confirms the Product Quality. The same fundamental is applicable to API for which Key Starting Material (KSM) is sourced for API manufacturing. ... Read More
Difference Between CSV and CSA
Definition Computer system validation (CSV) is the process of ensuring that a computer system meets its intended use and performs as expected, while computer system/software assurance (CSA) is the process of ensuring that a computer system is secure, reliable, and available. Purpose The purpose of CSV is to ensure that ... 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
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 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