Life is a Journey..how to make the best of it!

BayBiotech.NET Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions: 1. Lack of 356h, 1571, or 2252 forms in a submission. 2. Lac

BayBiotech.NET Orphan Drug is a special status designated to a drug or biologics to treat a rare disease or condition. In order to obtain this designation, drug or biologics must meet certain criteria. Orphan designation qualifies the sponsor for the tax credit and marketing incentives as per Orphan Drug Act. In addition, orphan drug is not subject to a prescription drug user fee unless used for other indications. For application purposes, sponsor shall submit two copies of a completed, dated, and signed request for designation that contains the following: (1) A statement that the sponsor requests orphan drug designation for a rare disease or condition. (2) The name and address of the sponsor; the name of the sponsor's primary contact person. (3) A description of the rare disease or condition for which the drug will be investigated. (4) A scientific rationale for the use of the drug for the rare disease or condition. (5) Where the sponsor of an already approved orp

BayBiotech.NET Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility: 1.General information (a) name of establishment inspected (b) date of inspection (c) name(s) of the inspector(s) (d) date of last inspection. 2.Type of inspection Comprehensive, concise, follow-up, special, investigative, announced, and unannounced. 3.Licensing (a) licensing of premises (b) person with supervisory role in establishments (c) adherence to licensing provisions. 4. Activities undertaken on premises manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes. 5. Adequacy and suitability of pre

BayBiotech.NET The U.S. Freedom of Information Act (FOIA) is a law ensuring public access to U.S. government records. Upon written request, agencies of the United States government are required to disclose those records, unless they can be lawfully withheld from disclosure under one of nine specific exemptions in the FOIA as under: (1) Information specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy. (2) related solely to the internal personnel rules and practices of an agency; (3) specifically exempted from disclosure by statute provided that such statute requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or establishes particular criteria for withholding or refers to particular types of matters to be withheld; (4) trade secrets and commercial or financial information obtained from a person. (5) inter-agency or intra-agency

BayBiotech.NET Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment. Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams. Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice

BayBiotech.NET Two ISO documents recently published provide harmonized principles and guidelines for the security of electronic health records. ISO/TS 21547:2010, Health informatics – Security requirements for archiving of electronic health records – Principles covers the basic principles needed to securely preserve health records in any format for the long-term. In the document, a holistic process covering records maintenance, retention, disclosure and eventual destruction has been extensively covered. Additional guidance for implementing ISO/TS 21547 is included in technical report ISO/TR 21548:2010, Health informatics – Security requirements for archiving of electronic health records – Guidelines. This report provides complementary guidelines to ISO/TS 21547, as well as a practical method and tools for the development and management of eArchives. Main features include the retention and records maintenance for a patient for entire lifespan reaching to 100+ years regardless o

BayBiotech.NET Standard Operating Procedures (SOP) are valuable tool that go beyond the basic procedural description of materials and methods and provide details about the appropriate precautions. A well written SOP is always a binding document in a regulatory environment and defines the details of the procedure to be followed across the board within an organization to perform a specific procedure. A well written SOP for a particular procedure should evolve with time after repeating the process under Research and Development Unit by testing the feasibility of the steps that makes it an easy to follow methods and minimizes the risks for Out of Specification reporting later on. A well evolved SOP has its origin from a simple stepwise flow chart of a complete process. If any changes are made in the process the SOP version in use must be updated by approval of the appropriate authorities and must be brought in use and supersede any other previous versions. A typical SOP contains the