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…
The conductivity meter is used to measure the conductivity in the solution. It is also known as an EC meter (Electrical conductivity meter). It consists of a probe. The probe is used to measure the conductivity of the solution. Two…
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 control sample is a portion of a finished product or raw material’s specific lot or the packing material’s few units, preserved in a control area for future analysis and reproducing purposes. Retention of the control sample is a part…
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…
SOP for Hard Gelatin Capsules Empty hard gelatin capsules are very sensitive materials used in pharmaceutical companies to manufacture capsules. Empty hard gelatin capsules are very hygroscopic and heat-sensitive which can damage a very slight change in temperature and moisture.…
The pharmaceutical industry is highly dependent on quality control laboratories for their product quality enhancement. The analysis is a continuous process that demands a high level of supervision and periodic validation. To maintain the functional importance of analysis, regular supervision…
Thermometers are a very crucial instrument in the pharmaceutical lab. The output results obtained from the thermometers can impact highly on the whole analysis process done in the lab. To meet the best result a proper SOP for the calibration…
HVAC systems function as active thermal energy transporters, overcoming natural entropy to maintain specific environmental states. Operation is dictated by the Second Law of Thermodynamics: heat naturally migrates toward lower energy states. Reversing this flow—extracting thermal energy from a cool…