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Pharmaceutical Validation & Qualification Introduction.

Image relates to pharmaceutical validation.

Bio-Med and Pharmaceutical Validation & Qualification is more than just raising an IQ and OQ. It requires an understanding of the the overall quality requirements as detailed in 21 CFR Part's 820, 211, 210 and 11. The process starts at the procurement stage with the VP, and continues through the URS - DQ - VRA - IQ - OQ - PQ and is achieved with the completion of the process qualification (PQ). The equipment must then be controlled throughout its working life by Change Control, which is there to guarantee that its validated status is maintained and never compromised. Incorporation of any updates or modifications requires a thorough understanding of both the business processes being supported and the associated regulations - GMP .

What is Validation or Qualificatiohn?

Bio-Med and Pharmaceutical Validation or qualification can be very simple and straight forward, and then again at times, it can be complex and difficult. A great deal depends on the contents of the company Corporate Quality Manual. This is where all company approved bio-med and pharmaceutical validation and qualification regulatory Practices and Procedures must be defined and documented.  Failing this being in place, the VMP and VP must document the validation procedures that the company has decided are required.  The protocol writers and executors must then follow these instructions.
It can; at times, be almost impossible to split such systems into computers and or equipment; therefore the system must be considered, taking note of the specifics of each and the overall functionality achieved by the system. While recognizing that the diversity of software, as defined in GAMP 4 & 5 is vast, you have to remember that the typical operating systems (windows or similar) because of the vast number in service, are taken as standard, and do not require to be qualified. Therefore when you come to application programs; that run on these standard operating systems (STS), your system qualification effort does not have to include the STS; just the application program itself. 

Gamp Class


Pharmaceutical Validation Scope




Record Version


Measuring Devices bespoke software.

Record Configuration & calibration




Review supplier & validate functionality and any bespoke code.


Large Configurable Systems

Audit supplier, validate system functionality and review code IAW full life cycle requirements.


Systems Specifically written for Owner.

Audit supplier, validate all code IAW full life-cycle requirements.

Contentious Points.

The EU GMP Annex 11 on Bio-Med and Pharmaceutical Validation & qualification of equipment, requires that there should be "adequate alternative arrangements for systems that need to be operated in the event of a breakdown". These arrangements should provide for alternative workaround procedures to be implemented and followed, to replace the absent system functionality and allow safe continuation of business during the failure.

Regulators, and internal / external auditors, require evidence that Business Continuity Plans have been created and rehearsed, including records that the alternative processes have been suitably documented and personnel adequately trained. Companies should be able to demonstrate that they can ensure that critical services and processes can continue, that the restoration of workforce, facilities and equipment occurs in a timely fashion and that there is a timely resumption of essential business functions.

This Pharmaceutical Validation graphic depicts the documentation required for revalidation.
This Pharmaceutical Validation graphic depict the document flow for relocation activities.

Define Validation.

In pharmaceutical validation and qualification regulators require documents to be based on agreed and approved policies and procedures. That means you can't start writing an Installation Qualification (IQ), without having an approved  (VP) in place to scope the IQ activities, and of course the VP can’t be started Pharmaceutical Validation Plan unless there is an approved User Requirements Specification (URS), in place to define the requirement that are to be qualified and validated.

This Pharmaceutical Validation diagram illustrates the sequential flow of documents that the regulators expect.

Management Control.

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The VP, or in major or new systems, VMP, should be the document that starts the bio-med or pharmaceutical validation or qualification process. The VP/VMP must give management's reason for requiring the validation task, along with documenting the justification and scope. It must further delegate responsibilities for all the qualification activities, and set the scope of these actions. At this stage a Risk Assessment (VRA) should be used to set this scope. Once these high level decisions are made, the VP must be signed off as a working document that has now set the company’s validation and qualification requirements for this piece of equipment.

Once proposals to satisfy the URS have been received, they are required to be qualified by the execution of a Design Qualification (DQ), which must confirm that the design proposal, if proceeded with, will satisfy the requirements as detailed in the URS. Personally, I cannot over emphasize the importance of the DQ. I have seen some horrendous blunders perpetuated by some really clever dedicated individuals, just about all of these blunders would have been caught at DQ level, if there had been one.

Protocol authors can now write the IQ – OQ – P1Q – P2Q documents, in accordance with the company’s approved practices and procedures. Whether Performance Qualification P1Q and Process Qualification P2Q are both required depends on your VP. A machine can have a range of settings and functions, perhaps you only want to validate one process – perhaps you want to validate the entire functionality - perhaps your product is too expensive to waste and you intend to use a placebo to validate the actual process settings.

This graphic represent the relationship between the pharmaceutical validation documentation train.

Document Justification.

There are many consultants that would argue; that you must start at User Requirements Specification level (URS), since your P2Q is based on verifying that the URS has been satisfied.  This is where the justification for your approach must be documented in the VP, without the end user documenting what the equipment is required to do (the exact measurable process and specifications), how can you scope a P2Q?

When a P2Q that is carried out using equipment that has not been the subjected to the above procedures, (or a very near justified equivalent), it has no standing and all product subsequently produces would be considered by the regulators, as adulterated.

Good Manufacturing Practices.

CAPA remains the single most cited subject in the Bio-Med and Pharmaceutical qualification industries, with 50% of FDA warning letters being concerned with CAPA problems.

Why does this not surprise me?  Because having worked in the industry for many years I I have worked with many companies who paid scant regard to the subject.  Yes, there are companies around who do the job properly, but according to statistics, half don’t.

I think most persons who have worked in the industry for any length of time, have seen the occasion when production output has taken priority over the proper investigation of customer problems and or complaints.

The catch-22 is always cost, is it more cost effective to have a compliant CAPA system, that is not only keeping you compliant with regulatory requirements, but also producing data that enables you to reduce customer complaints and quality deviations; or is it more cost effective to pay lip service to CAPA requirements on the bases that you don’t have many customer complaints.

Our most popular purchase still remains the Package 3.  This contains all the protocols and associated procedure documents required to carryout a validation task.

Our most common technical inquiry is still the question asking; Does a validated piece of equipment, that is moved from one area to another, require to be revalidated, even if the move is only across a room.


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.