Tag Archives: records

  • Should we be using iPhone video procedures?

    … for the 1940-50’s. Other industries have long since moved on and so should the pharmaceutical industry. Use of modern video records, diaries and commands should become the new accepted practice bringing our industry into the 21st century. Scientific studies prove that these types of tools are much more effective in assuring that processes are properly operated compared to written procedures which frequently collect dust on the shelves. Perhaps the time is right to be more interactive and …

  • Lean Philosophy and the Life Science Industry

    … process will fail for a variety of reasons. Integration of primary synthesis unit operations with those for recovery, purification and subsequent formulation and final finishing requires many break points, testing points and detailed production records. These are the elements that help define a process and often how this process is operated defines the chemistry and pharmacological activity and utility of the product. It is these factors that one needs bear in mind when adapting the principles …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … manually record data on paper batch records – are still being used in some plants, and transitioning from this early evolutionary stage to the principles set forth by PAT places an enormous negative impact on a company’s ability to analyze data and control processes, take necessary corrective and preventive measures, and pursue continuous process improvement. The pharmaceutical industry has been similarly slow in fully adopting lean manufacturing, again, because of culture and mindsets. …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … together to achieve goals. Asking questions, requiring solid references, and carefully examining track records can go a long way toward ensuring the fit that ensures success. 7. Willingness to Build Relationships Consultants are not just contractors who are called in to do a job, and then disappear when the job is finished. Good consultants have to be willing to establish long-term relationships. The right pharmaceutical consultant for your company is the one willing to establish a relationship …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … in finding the right consultant to move your organization from the starting point to the desired goal. Make sure the knowledge and experience are there. Another important step is to make sure the prospective consultant has the necessary expertise – in the form of knowledge, experience, and qualified personnel – to do what you need them to do. Read their publications, check references, and scrutinize track records. Ask lots of questions. Ask yourself and the prospective …

  • Advances in Pediatric Personalized Medicine Are Highlighted at Unique International Conference

    … life are due to this condition. The occasion also prompted exchanges that help address crucial concerns created by personalized medicine, for example: -Genetic discrimination -Cost-benefit analysis -Universal standards for managing genomic information in electronic medical records -Biobanking -Strategies to educate practitioners and patients Children’s Mercy Hospitals and Clinics is a national leader in pediatric personalized medicine, and they are about to launch two new programs to …

  • How to Get Through a Successful Pre-Approval Inspection

    … commitments to ensure the authenticity and accuracy of any data contained in your company’s submitted application file.  It is the inspector’s job to thoroughly inspect your facility, as well as any records or data you have available, to make sure that your site produces reliable data information, and that all key GMP systems are up to code with current GMP standards. Thorough preparation work is absolutely paramount when ensuring that your company is successful in getting through …

  • Compliance Tips For cGMP Inspections

    … Once you are ready to begin the FDA inspector will notify your company the exact purpose for the inspection, and roughly how long it will take for them to complete their audit.  You will want to supply the inspectors with an office room, or conference room, so that they can set up a base of operation, and review their records and files. The inspection itself, usually involves a combination of physical plant inspection, as well as possibly document and record review.  This may also include any …

  • Failing an FDA Inspection

    … will closely scrutinize every part of the company’s dealings including its own internal audits, clinical records, and where the money is going.  Your company could then be forced with a wrong acts, or fraud lawsuit and your company could be closed down permanently. If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention …

  • LIMS for Lab Quality Control

    … Analytical method validation and documentation –    Computer software validation –    records of deviations from lab procedures –    Determination of the right QC controls, which deal with the daily quality of analytical data developed LIMS can define specific lab personnel and their particular working environment, defining the activities they can perform and information they can access.  It offers a way to allow users to be approved to do certain functions, and the …

  • Ensuring QC for Laboratory Operations

    … This is the way to record how a product is produced, tested, packaged and stored, so, all documentation must be clearly identified and complete.  Every procedure must be clearly documented to ensure controlled use and any implementation of planned changes.  Procedures should reflect the actual practices and must govern the quality and integrity of the data being produced to support the product.  Every change, no matter how small, must be immediately documented. 5.    The laboratory records …