SOP for cGMP REVIEW.


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SOP for cGMP Review Scope.

This SOP for cGMP Review, has been produced in response to numerous requests for such a document. Now you can do your own walk validation project assessment. The purpose of this procedure is to ensure that all relevant aspects of the proposed design are reviewed for cGMP compliance by the qualified personnel, in a controlled manner. Thus ensuring that the design and/or the facility meets the cGMP requirements, and that documentation is produced which demonstrates that the design conforms to the requirements of cGMP.

This procedure defines how cGMP Reviews are carried out for Engineering and/or Consultancy Projects from project kick-off through to handover, to ensure that the design intent has been carried out and the facility as designed (and subsequently as constructed) conforms to the requirements of cGMP.


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Requirements.

For pharmaceutical/biopharm facilities where it is necessary to seek and gain approval from Regulatory Authorities, it is essential to demonstrate that the design and/or facility complies with current Good Manufacturing Practice (cGMP) requirements as defined by the Regulatory Authorities from which approval is being sought.

The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation having influence on the quality or efficiency of the product.

    PURPOSE
  • SCOPE
  • DEFINITIONS.
  • METHOD
  • Introduction.
  • Timing.
  • Information Requirements.
  • Responsibilities.
  • cGMP Review Team
  • cGMP Review Meeting.
  • Change Control.
  • Follow Up / Close Out.


Qualification Documentation.


SOP for cGMP Review



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.