FDA GMP PLANS.


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Defining FDA GMP PLANS.

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FDA GMP PLANS include schedules that will slash the number of scheduled quality inspections it routinely executes in the U.S. each year by 40 percent.  The saved time will be utilized in conducting more inspections overseas. The shift is driven by the desire to improve the quality of the drugs being imported.  Twinned with this is a long-time goal of standardizing U.S. and foreign inspections, so that foreign drug manufacturers would be as likely to be inspected as U.S.-based facilities.

The FDA plans to oversee 591 national GMP inspections in fiscal 2014 and 2015, reduced from 967 performed last year.  Consequently the agency plans to perform 30 percent more foreign GMP inspections, increasing last year’s total of 604 to a new grand total of 843 inspections.

Companies will now be chosen for inspection using the agency’s risk-based inspection model that equates inspection periodicity to company quality practices and procedures.  This risk based model develop specifically for FDA cGMP use, takes into account risk factors; such as, Class I recalls, adverse events, as well as compliance history as it assigns an appropriate inspection cycle.


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FDA GMP Manual.

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The FDA GMP PLANS include a compliant, Corporate Quality Manual (CQM) which is a lengthy fully detailed manual containing all the policies and procedures that the regulatory authorities require approved organizations, to have in place.

The Corporate Validation Manual is the start of all compliant documentation. The policies container in it, dictate what documents must be raised and details the scopes and responsibilities in raising, approving and executing them. Here our CQM goes a great deal further, in containing interactive downloadable templates for, Validation Master Plan - VMP - Design Qualification - DQ - Installation Qualification - IQ - Operational Qualification - OQ - Performance Qualification - PQ - User Requirements Specification - URS - and many more documents, all of which are compliant with Good Manufacturing Procedures GMP, GAMP 5, Food and Drug Authority - FDA, Medicines and Healthcare products Regulatory Agency (MHRA) and all applicable rules and regulations.

Authoring and publishing a Corporate Validation Manual is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing.

Our FDA Compliant, manual preface is constructed in the format of a Standard Operating Procedure - SOP. This SOP takes you through the simple several stages of populating the Corporate Validation Manual. This standard manual template is progressively transformed into your own new company bespoke Corporate Quality manual.


FDA GMP PLANS.


SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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