Tag Archives: needs

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • Reaching into Research and Development of a Supply Chain Strategy

    … selection of raw materials and components and their suppliers early in the development cycle. The strategy should be based on risk management principles and the needs and demands of the commercial market. The strategy would consider the unique attributes of the material and suppliers balanced against the potential risks that may be encountered when manufacturing for the commercial market. To read the full white paper, click on the following link: Reaching into Research and Development for …

  • Metrics and their Importance in Lean Biomanufacturing

    … consistently made product with very tight technical and quality specifications. In developing Lean approaches to these manufacturing processes, metrics provides the information which is the life blood from which biochemical engineers can balance the needs of meeting quality specifications with running the process plant as efficiently as possible. A key metric in any biological process is the changeover time, since this is where production time is lost. As a result this is a valuable data set …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    When employing a Lean approach to pharmaceutical (Life Science) manufacturing, the implementation of a Visual Factory Methodology as part of the approach can have a very significant impact. The goal of Visual Factory implementation is to permit the very efficient transfer of information that can have a material effect on the performance of the manufacturing plant. Two parts are critical in implementing this:  – Deciding what the necessary information is that needs to be conveyed. …

  • 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 …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    … strategy is a must today. This type of approach helps to define exactly what’s required to provide the appropriate level of coverage to assure compliance and meet the needs of ICH/FDA and other international regulations & guidance’s as well as maintaining a competitive edge to assure your company’s leadership position in the market place. Through the application of Lean Compliance, you can meet your regulatory obligations and maintain your competitive edge! A good example to illustrate …

  • Critical factors in Filing NDC numbers with the FDA

    There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product: 1. Whether the label is different 2. Whether the formulation is different 3. Whether the packaging is different If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product. Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … and then determines the steps and methods necessary to get you from here to there. Selecting just the right consulting firm for your company and your needs involves not so much examining what the consultants can do, but how they do it. Below are 7 key considerations to choosing the right pharmaceutical consultant. 1. Honesty Now this may seem painfully obvious, but it is something you just can’t afford to overlook. Consulting firms generally offer a broad range of services, and some have …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … Before hiring a pharmaceutical consultant, you absolutely must do the necessary preliminary work. Neglect these important steps, and you could be courting disaster: Identify and define your needs. The first step prior to calling in a pharmaceutical consulting firm is to carefully analyze and define your goals for your company. What, exactly, do you want to accomplish? What specific problems do you need solutions for? Knowing where you are now and where you need to be will be immensely helpful …

  • Innovative R&D Through Lean Manufacturing Principles

    … results. This is where the implementation of lean manufacturing solutions can be extremely beneficial. Further, the process of identifying and developing potential new drug candidates comprises both scientific and business elements. Teams have to be optimally aligned, various activities must be coordinated, information needs to be adequately disseminated and easily accessible, and decisions must be properly coordinated in a timely manner. These are just a few of the process pieces, and they all …

  • How to Perform a Mock Audit

    … character” throughout the whole process to get the best out of the activity. It can be educational to invite managers, executives, and members of other projects to observe the mock audit; and it is because of the educational aspect that the mock audit requires immediate and thorough review of the lessons learned after it is finished. The review process has to include: -Comments from the mock inspector in regards to what was done well and what needs improvement. -Observations from the QA …

  • What You Need to Know About Vendor Audits

    A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.  This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving …