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…
Sanitization of the Production area in a Pharmaceutical manufacturing company is a very crucial job that requires a high degree of alertness. The same precaution is necessary to prepare the sanitizing solution to perform sanitization. The concentration of the sanitizing…
Validation is a concept used in the Pharmaceutical manufacturing industry. US-FDA had been invented in the mid-seventies in pharma product analysis. This is documented proof of a process to be consistent over time. The Importance of Validation in Pharmaceutical companies…
The production area is one of the most sensitive areas in a Pharmaceutical manufacturing company. This area requires the highest level of cleanliness and free from rodents, insects, and birds. Any living body (rodents, Insects, rats, bats, and birds)…
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…