These guidelines are the non-clinical version of the GCP It also covers animal welfare during laboratory trials. Like any other form of GxP, GLP also requires extensive documentation of aspects of its envelope. This includes thorough documentation of lab samples and test animals. Experiments conducted ...

GMP stands for Good Manfufacturing Practice and GLP stands for Good Laboratory Practice. Though both are ensuring the quality of pharmaceutical products they have also few differences. GMP vs. GLP GMP covers whole manufacturing facility. GLP covers only quality control laboratory. Good Laboratory ...

A major advantage of computer systems in the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records that are easy to process, store and retrieve. Due to advances in information technology, health record management has become very easy. 21 CFR regulations are ...

Good Manufacturing Practice (GMP) is a process that ensures that products manufactured by pharmaceutical companies are of quality. GMP is incorporated into the production system and thereby minimizes or eliminates risks in the final product produced. GMP is integrated in all stages of production from ...

The Good Laboratory Practice (GLP) regulations require the validation of computerized systems used in laboratories to ensure they are suitable for their intended purpose. These systems include those used for data generation, measurement, calculation, assessment, transfer, processing, storage, or archiving ...

The GLP Principles set out the requirements for the appropriate management of nonclinical safety studies. This helps the researcher to perform his/her work in compliance with his/her own pre-established scientific design. GLP Principles help to define and standardise the planning, performance, recording, ...

Safety rules applicable for laboratory operations must be adhered to by all analysts performing the analysis. Though these require the desire on the part of individual analysts to protect themselves and their associates by following a set of rules, these rules shall be mandatory for all personnel working ...

Manager QC or his designee shall assign the analytical work and allot samples to trained and approved analyst. After getting the sample allotted, the analyst shall collect analytical worksheet/s depending on the number of samples, and get the same approved by QC manager or designee. The analyst shall ...

To the uninitiated, the difference between GMP and GLP can be a tough nut to crack. But as the names suggest, it is a no-brainer to uncover that they both deal with laboratory testing and ensuring the safety and integrity of drugs and chemical products. These terms often confuse many people and it is ...

In case of machine breakdown, raise a repair request or share a mail as appropriate to either engineering department or service provider. A duplicate copy of the request / mail shall be retained in QC. Label the machine with a ‘Under Maintenance’ label and make appropriate entries in the respective ...