Pharma Digest
Highlights of Recent FDA Guidance on Nitrosamine Drug Substance
For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More
Good Practices for Research and Development (R&D) Facilities | WHO Guideline
With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented. Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit ... Read More
WHO GMP Guideline for Excipients Used in Pharmaceutical Products
The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical ReportSeries No 885, 1999. As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product. ... Read More
FDA Findings and Remedies on cGMP Violations
The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control ... Read More
Difference Between QbD and DoE
Quality by Design (QbD) vs Design of Experiments (DoE) (concepts comparison) Definition: Focus: Application: Approach: Read also: Resource Person: Atefe Nasrollahi
Good Laboratory Practice in Microbiology Laboratory
Good microbiological laboratory practices (GMLP) are designed to protect both workers (i.e., lab staff, non-lab staff and researchers) and research material (i.e., organisms and equipment) in the microbiology laboratory. It consist of activities that depend on several principles: aseptic technique, control of media, control of test strains, operation and control ... 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
In-Process Control Procedure in Pharmaceutical Industry
IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process monitoring in order to comply with the specifications. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, ... 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
Difference Between Calibration and Qualification
A list of differences between calibration and qualification are mentioned below: Similarities Read also: