By Darshan Singh, QC/QA and regulatory affairs, 23 years in pharmaceutical quality. Revised 21 September 2026 against IPC’s harmonised draft of IP 2.5.1, USP <701>, Ph. Eur. 2.9.1 and JP 6.09. Calibration in one card A disintegration test apparatus is…
Glassware used in Laboratory is very important equipment for valid analysis practices. If a 1ml pipette delivers 0.01 ml less or more in testing, the result of the analysis may differ more than 10 percent from actual results, so that…
Short answer. An out-of-specification result is a laboratory test result that falls outside a specification. Environmental monitoring data are not measured against specifications at all. They are measured against alert levels and action limits that the manufacturer sets from qualification…
Comprehensive Guide: SOP for Preventive Maintenance of HPLC HPLC is a very sophisticated instrument in the laboratory. This machine requires high alertness and care while operating. HPLC is a widely used analytical method in the pharmaceutical industry. It is a…
The procedure for preventive Maintenance of Lab Instrument is documented and approved by the Quality Control Manager and Quality Assurance manager after duly verification. It is very essential to prevent lab instruments from any breakdown during their operation and use.…
A fluidized Bed dryer is an important equipment in the granulation section of the tablet manufacturing area of a pharmaceutical manufacturing company. It is necessary to have a written document for the cleaning of FBD in the form of an…
The quality of products manufactured in a pharmaceutical company depends on the environmental conditions provided during it’s manufacturing. Pharmaceutical products are highly sensitive to the temperature and humidity of the premise where they are being manufactured or stored. Most of…
A situation where all viable microorganisms and organisms are not able to reproduce is called sterile. Sterile means the complete isolation of microorganisms whether they are pathogenic or not. aseptic-vs-sterile Aseptic definition: It means the absence of pathogenic organisms and…
Written by Darshan Singh, M.Sc. Chemistry, 23+ years in pharmaceutical quality control, quality assurance and drug regulatory affairs. Reviewed against USP General Chapter 621 (harmonised text, official 1 December 2022) and ICH Q2(R2). Short answer What are the types of…
The pharmaceutical industry is a highly regulated industry by Drug Departments. Every action in the pharmaceutical manufacturing company needs to be documented and verified. Action without documentation is understood as manipulation or out of specification because without SOP no action…