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…
The pharmaceutical industry is highly dependent on precise temperature and relative humidity control to produce high-quality and safe products, HVAC system is a technology that provides the answer to the needs of the pharmaceutical industry. The term HVAC refers to Heating, Ventilation,…
A stability chamber works on the principle of maintaining the relative humidity (RH) and temperature of the chamber with the help of thermostats and water reserved in the chamber. As per the law of physics, the air can maintain…
Principle of autoclave The autoclave functions to sterilize the subjected material by generating steam pressure inside the chamber at a standard vaporizing temperature, maintaining the conditions for a certain time frame. The whole process is moist heat sterilization which is…
ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) is a globally recognized framework mandated by regulatory bodies like the FDA, WHO, and EMA to ensure data integrity in the pharmaceuticals manufacturing industry. Originating from the FDA’s 1990s ALCOA guidelines, it evolved into ALCOA+ in the 2010s to…
The pharmaceutical industry is the most highly regulated industry in the world. Every pharmaceutical manufacturing company has to face various audits by the Drug department and other players. To comply with the requirements of audits companies have to prove that…