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GMP Transgressions and Citations.
October 31, 2012

GMP Transgressions and Citations.

 

When the market is lean there should be even more reasons for ensuring your company’s GMP compliance is being diligently applied and rigorously managed.  This is not the best time to be presented with citations for breaches in your regulatory compliance obligations; nor is it a good time to be facing any product recall issues.  Yet; currently, these problems actually appear almost endemic throughout our industry.  These regulatory lapses can debilitate a company and possibly result in a reduction in end user confidence in using or specifying company products. 

 

So now is the time to ensure that those validation protocols and plans are comprehensive, precise and regulatory compliant.

 

Where can this confidence in your GMP come from?  Quite simply it comes from the proper and diligent use of the three top level validation documents; User Requirements Specification (URS), Design Specification (DS) and the Design Qualification (DQ).

 

The URS, has detailed the actual needs of the end user, in functionality, training, documentation, engineering drawings and support.

 

The DS, is a detailed design put forward (either from an in-house resource or from a vendor) which will satisfy all the requirements detailed in the URS.

 

The DQ, must verify that the DS will in fact satisfy the URS. 

 

This is the level that all aspects of design, installation, operation, maintenance, documentation, training, calibration, cleaning and installation, are challenged at.  The satisfactory execution of the DQ confirms that this DS satisfies all applicable requirements as detailed in the URS, cGMP and the Health and Safety regulations.   It also documents the fact that all supporting requirements have been reviewed and the review has been approved by management.

 

At this stage the Validation Plan can be completed (it may have started earlier, but cannot be completed until the DQ has become an approved document).

 

The VP scope can now be detailed and, responsibilities and methodologies can be detailed.  Having fully detailed the support documentation (FAT, drawing, specifications, calibration certification) in the URS, the IQ and OQ will flow quite easily.

 

The documentation dovetails together and actually presents you with a simple (at each stage), logical, traceable and cost effective validation methodology that now must be rigorously applied and managed.

 

URS – DQ – VP – VRA – IQ – OQ – PQ

 

Simple to use and highly cost effective when used.

 


Click here to view the FDA requirements for protocol testing formats and wording.

Click here to access the Combined IQ/OQ/PQ protocol details.



If assistance is required in selecting the appropriate documents then please contact us TOLLFREE at 1-877-778-8085...........When out of office hours; please leave a voice message at 1-877-778-8085 and we will contact you.


Validation Master Plan (Issue 7) -- $115.00

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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User Requirements Specification (Issue 7.) -- $115.00

The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. 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 URS through to the final PQ and OQ functionality testing. This is a mandatory requirement for Full Life Cycle Validation (FLCV) of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or managed systems.

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Design Qualification (Issue 4.) -- $115.00

The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

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

The SOP used to generate this 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. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.


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

You will find the step by step attached SOP 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 Operational Qualification Protocol. 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. Template for VMP.

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Performance Qualification (P1Q) (Issue 5.) -- $89.00

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and cannot be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste. Template for VMP.

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

The Process Qualification is the culmination of the validation process. 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 recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification produce being produced.

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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 categorising 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. Template for VMP.(now mandatory).

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