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…
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…
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)…
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…
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.…