QA
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
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