1. Put a weight machine to measures paper waste in QA…to check how many paper we shredded per months.. May be tons off.. 2. Build awareness among the people by showing the data.. 3. Make a campaign to reduced the waste.. That not only for the organization, for society also..because Good Health can’t wait.. 4. […]
Web presentation is an innovative idea to share pharmaceutical Knowledge, following PPT’s are updated currently 1. QRM – On Quality Risk Management 2. Make your company presentation 3. A brief review on HVAC system [youtube=https://www.youtube.com/watch?v=3UQL-J2YedE&w=320&h=266] http://www.slideshare.net/PalashDas10/slideshelf
Audit is always additional headache for Pharmaceutical industry. People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority. We are the knowledgeable fellow of our organization, […]
What is a DMF? Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Important facts regarding DMFs It is submitted to FDA […]
Like 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 were made in keeping with procedures and GMP expectations. Reports are yet another […]
Observation 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 samples were retested until acceptable results were obtained. In addition, Quality Control (QC) […]
Most 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 equipment, and information about training of their laboratory staff as justification for the […]
The 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 is doing now and, thus, it provides a basis for planning what it […]
The 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 Quality System Regulation (QSR) for medical devices, include CAPA. This requirement for medical […]
Smoke study or air flow visualization is the important factor in clean room qualification. My query to some experts were as following 1. What will be the requalification frequency for Smoke study?2. If there is no significant changes in the clean room design is it require to do periodic evaluation of smoke study?3. Any Guidance […]
