QA & QC

USFDA Guidance on Quality Metrics Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to FDA: to help develop compliance and inspection policies and practices, such as risk-based …

Quality Measures Quality measures are designed to drive healthcare quality, and they also influence measured entity payments, reduce risks to individuals, and affect measured entity burden. That is why it is so important that quality measures be vetted to verify that they do, in fact, indicate quality and drive quality …

Troubleshooting There is no standard troubleshooting procedure. General Pattern: Locate the problem by ranking possible causes. Verify the presence of the most probable cause. If present – fix the problem, otherwise verify the existence of the next possible cause. Two Types  of HPLC troubleshooting System problems or Method problems HPLC …

Change management As Per WHO TRS1019 Annex 3 Manufacturers should follow change-control procedures when changes are planned to existing systems or processes. The change-control procedure and records should ensure that all aspects are thoroughly documented and approved, including regulatory approval where appropriate (variation). Sufficient data should be generated to demonstrate …

Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. Quality Metrics play an important role in the desired state of pharmaceutical quality and regulation – minimal but effective regulatory oversight that …

Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as a “highly purified compound that is well characterized” (1). The US Pharmacopeia (USP) defines reference-standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators” (2). Scientists …

REMEDIATION OF DATA INTEGRITY FAILURES Responding to Significant Data Integrity issues Consideration should be primarily given to resolving the immediate issues identified and assessing the risks associated with the data integrity issues. The response by the company in question should outline the actions taken as part of a remediation plan. …

Classification of data integrity deficiencies To aid consistency in reporting and classification of data integrity deficiencies Deficiencies relating to data integrity failure may have varying impact to product quality. Prevalence of the failure may also vary between the actions of a single employee to an endemic failure throughout the inspected …

Out of Specification & Out of Trend Investigations as per MHRA Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: • Batch release testing and testing of starting materials. • In-Process Control testing: if data is used …

HPLC Interview Questions Question 1: What is Full form of HPLC? Answer: HPLC stands for High-performance Liquid Chromatography or High-pressure Liquid Chromatography. Question 2: What is HPLC Principle? or What is Principle of Chromatography? Answer: It is a chromatographic technique used to separate the components from a mixture of a …