Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart…
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read moreLike procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions…
read moreObservation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch…
read moreMost companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical…
read moreThe basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it…
read moreThe concept of Corrective and Preventive Action (CAPA) has doesn’t specifically appear in the older version of Good Manufacturing Practices. CAPA seems to have become popular in the pharmaceutical industry because of its use with medical devices.[ISO 13495:2003 and the FDA’s 1996…
read moreFault tree analysis The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various combinations of…
read moreFailure Mode Effects Analysis (FMEA) Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” means the ways, or modes, in which…
read moreRisk assessment is a systematic examination of a task, job or process that you carry out at work for the purpose of; Identifying the significant hazards that are present (a hazard is something that has the potential to cause someone harm or…
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