QA
Role of QA in New Drug Development and Approval
Introduction The development and approval of new drugs involve a complex process, requiring rigorous quality assurance (QA) measures. QA plays a vital role in ensuring the safety, efficacy, and compliance of new drugs. In this blog, we’ll explore the critical role of QA in new drug development and approval. Why ... Read More
Handling Customer Complaints in Pharmaceutical Industry
Introduction Customer complaints are critical events in the pharmaceutical industry, requiring prompt attention and resolution. Effective complaint handling ensures patient safety, maintains regulatory compliance, and upholds company reputation. In this blog, we’ll explore best practices for handling customer complaints in pharmaceutical QA. Key Principles Regulatory Requirements Complaint Handling Process Best ... Read More
Pharmaceutical QA for Packaging and Labeling Controls
Introduction Packaging and labeling play critical roles in pharmaceutical product integrity, safety, and compliance. Quality assurance (QA) measures must ensure accurate labeling, secure packaging, and compliance with regulatory requirements. In this blog, we’ll explore pharmaceutical QA controls for packaging and labeling. Key QA Considerations Regulatory Requirements Packaging QA Controls Labeling ... Read More
Basics of Line Clearance in Pharmaceutical Industry
Line clearance is an essential process in the pharmaceutical industry to ensure the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch. The 3 C’s of line clearance, which ... Read More
Difference Between Quality Control (QC) and Quality Assurance (QA)
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 ... Read More
CAPA Process Steps in Pharmaceutical Industry
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 ... Read More
Vendor Audit in Pharmaceutical Industry
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 ... Read More
Drug Master File (DMF) in Pharmaceutical Industry
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 ... Read More
Vendor Qualification Under FDA and ICH Regulations
FDA, Guidelines, ICH
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. ... Read More
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
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