Pharma Digest
Annual Product Review in Pharmaceutical Industry
An annual product review (APR) should be conducted for every commercial product in pharmaceutical industry. The objective of this review is to: APR Relationship to the Quality System SOP for Annual Product Review (APR) Table of Contents Scope and Objectives 1. Applied separately to each product, or product groups, annually. ... Read More
Batch Production Record in Pharmaceutical Industry
Batch production record an important tool in Pharma industry. Always I do believe that, every GMP document in the Pharma industry should be written and reviewed by subject matter experts (SMEs). The insights of the document author and reviewer help in making the document written in logical sense with clear ... Read More
Quality Agreement Guidelines and Template
One of the biggest issues facing the pharmaceutical industry and patients today is quality, integrity and security of the pharmaceutical supply chain, preventing contamination (adulteration) and eliminating counterfeits. A suitable Supplier Qualification Program has hence to be implemented by each user of purchased APIs (or intermediates). A major element of ... Read More
Data Integrity in Analytical Laboratories
Data integrity in the analytical laboratories is an area of increasing focus for regulatory authorities such as FDA, EU, TGA etc. Data Integrity The data which is attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). During regulatory inspection/audit analytical laboratories have to provide information about the ... Read More
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