Introduction to GMP Gap Analysis.

This graphic is symbolic and used to enhance the appearance of this GMP gap analysis page.

A Validation gap analysis is usually the first thing a Validation consultant is requested to perform on meeting a new client. A reassurance that all discrepancies have been identified and reconciled - in house. When an existing problem is not discovered, acknowledged and remedied, and a visiting regulator discovers it, the issues can be, and very often are damaging to individual careers, and to the company.
Execution of the Validation Gap Analysis gives tremendous reassurance that the validation and compliance requirements of the company are being met.

Validation Gap Analysis tools allow you to systematically challenge the company’s cGMP compliance policies and procedures, comparing them with the regulatory expected standards and enables you to draw up a list of all the delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. It really is difficult and verging on the impossible to put resources together for an unmeasured task.

CAPA Warning.

Poor CAPA systems remain one of the top problem areas for both the drug and device industries when it comes to FDA inspections. And CAPA citations account for more than 50 percent of FDA warning letters. Are you certain your CAPA system is compliant –

- if not absolutely certain -


FDA and Gap Analysis.

The FDA brought out and now police compliance with the Quality Systems (QS) guideline's, that compliment the current Good Manufacturing Procedures and provide the tools for industry to implement effective QS’s that will guarantee the best product quality for the customers. The next step for most companies is to perform a Gap Analysis (GA) to determine what actions are necessary for them to be in compliance with the new guideline. The GA must be conducted as a planned / organized process and must be documented. The personnel conducting the GA compliance and validation analysis must also be qualified and must prioritize the areas to be inspected. It must be verified that the cascade of documents used in qualifying equipment i.e. VMP - VP - URS - DQ - IQ - OQ - P1Q - P2Q, are in place and all of them have have been constructed in accordance with the company's practices and procedures manual.


As long as the process operates in a state of control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability.

Validation Gap Analysis Tools.

Regulators require documents to be based on agreed and approved policies and procedures.  That means that the documents must flow from the top policy and procedure documents through the assessment and scoping stage and into the inspection and testing stage.  Throughout this flow, traceability must be maintained to demonstrate that the original requirements as documented in the URS have indeed been verified as delivered.  You can't start writing an Installation Qualification (IQ), without having an approved Validation Plan in place to scope the all activities, and of course the VP can’t be started unless there is an approved User Requirement Specification (URS), in place.  The normal and expected document flow is shown below:

VP - URS - DQ - VRA - IQ - OQ - P1Q - P2Q.

The first document is not mandated, but is always asked for in regulatory reviews.  (URS - DQ - VRA) are mandated and self explanatory.  (IQ - OQ - P1Q - P2Q).  The execution of a Validation Gap Analysis will give verification that these documents are in place and of acceptable standard.

Introduction to Validation GAP Analysis methods.

This graphic is symbolic and used to enhance the appearance of this GMP gap analysis page.

The aim and object of using a Validation Gap Analysis protocol in the bio-med and pharmaceutical industries is to identify the gap between the regulatory requirements governing the company operations and the practices and processes the company has in use. This helps provide the company with insight into areas that have room for improvement. The execution of a Validation gap analysis process involves determining and documenting the variance between requirements and current capabilities. Once the general expectation of performance in the industry is understood it is possible to compare that expectation with the level of performance at which the company currently functions. This comparison becomes the GMP gap analysis results. Such analysis can be performed at the strategic or operational level of an organization.

Of great importance is the review of the company Validation Master Plan (VMP). The VMP must detail the methods to be used and the individual responsibilities for all validation activities, it is therefore imperative that it is correct in all aspects of GMP and company policies and procedures.

Next in importance to the VMP is the assurance that all equipment validation activities are originated from a fully detailed User Requirements Specification (URS). Without the URS all validation activities would be flawed. The more detailed the URS, the easier and quicker the validation exercise is to execute. It therefore pays dividends to get the URS correct.

Sarbanes Oxley (SOX) 404.

Companies are now required to establish and maintain an adequate internal control structure and assess its effectiveness on an annual basis. Costs of compliance with Sarbanes-Oxley (SOX) 404 are, however, higher than planned.

Sarbanes-Oxley is the legislation introduced in the USA as a result of the Enron, World-com, and other financial scandals.  The legislation currently applies to all USA businesses and any business that trades its shares on a US stock market. Additionally, the UK Government is planning to introduce similar legislation to Sarbanes-Oxley in the near future. 

As Sarbanes-Oxley is gradually implemented, it will result in most business looking for systems that:

Improve security and close loop-holes that allow for errors and falsifications in financial records.

Introduce or support transparent processes that include all stake-holders, particularly in areas that have financial implications.

A document store that manages all of the documents, spreadsheets and other file types that need to be tracked and shared in the financial processes.

A system that ensures everyone that they are accessing the latest, correct version, track who made which changes with a full audit trail.

Document audit and edit, "red line" and "mark-up" the document without changing the original.

An audit full audit trail that even tracks if and when documents were read. A notification system that each user sets up, so they know automatically when something has changed, been read or reached a certain stage.

Discussions, bulletin boards and email stores, so that you facilitate process improvements and the move to best practice, and trap and record the history of these internal interactions. 


User Requirements Specification Template

The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. ules. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 

Corporate Validation Manual $1,160.00

This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.

Equipment combined IQ/OQ/PQ Protocol.   $159.00

This 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 procedures. The associated Validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. This of course may well be a validation Plan template. 
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design Qualifications and the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation 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 User Requirements Specification template.


Process Qualification (P2Q) (Issue 3.) -- $85.00

The Process Validation or Qualification is the culmination of the validation process as indicated in the Validation Master Plan template or at time Validation Plan Template and specified in the User Requirements Specification Template (URS). The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.

12000002 VrrP Equipment $298.00

This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format.  This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation master plan template executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.  This new document titled the VrrP replaces the VP, VRA & User Template Requirements Specification (URS) and now compliments our equally new 4Q Protocol, which integrates the Design Qualification and the IQ/OQ/PQ into one document. 
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Plan template.

12000006_4Q_Equip_iss-4. -- $298.00

4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols.   By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation  Online executables documentation and associated standard  operating procedures, by reducing protocol numbers by close to 75%. All as detailed in the Validation Plan Template. The new bang up to date 4Q protocol replaces the Design Qualification along with the IQ, OQ & PQ and now compliments our equally new VrrP Protocol.  By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.