Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production to ensure that they meet…
Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met. CAPA Subsystem in Context CAPA Process CAPA Sources Internal Sources External Sources CAPA Process Steps 1. Analyze Data Ensure all quality data sources are defined and analyzed to…
Vendor audit is an evaluation of a vendor manufacturing process, practices, documentations and quality compliance by offline (physical) or online (desktop). Conducting a vendor audit in the pharmaceutical industry is an essential process to ensure that suppliers and vendors meet the required standards and regulations. Vendor Audit Process Define Audit Scope Determine the scope and…
Drug Master File (DMF) is a package of confidential, proprietary assets, specifying the formula, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Types of DMFs Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II: Drug substance and…
All contract service organizations and vendors who supply the cGMP facility with critical supplies, reagents, and equipment must be qualified. This helps to ensure all products have been manufactured in a way that prevents the introduction of adventitious agents or toxic impurities and ensures final product safety, effectiveness, and consistency. However, setting up a supplier/vendor…
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. Grouping shall be justified. 2….
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 such a supplier qualification program…
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. Facilitate efficient data retrieval and…
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 managing change. Changes should drive…
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. Every company will have a…