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Validation Documentation

The title “Validation Documentation” refers to a suite of documents that the FDA, WHO and the EC have predicated as essential in establishing that a regulatory controlled product has been produced in compliance with current Good Manufacturing Practices (cGMP) and meets or exceeds all required specifications; as listed in the User Requirements Specification (URS).

Validation Documentation introduction.

The evolution of Validation required the development of suitable documents, such as the VMP, URS, DQ, IO, OQ, P1Q, P2Q. Many manufacturing processes produce a product or part of a product that cannot be tested without damaging it, or indeed destroying it. The introduction of QA allowed manufacturers to build and destructively test, then using rigorously enforced quality controls replicate the tested product exactly, now knowing its performance and limitations.
Pharmaceutical, biopharm and medical device companies must demonstrate to the regulators that their whole operation is under similar control.  Quality Control that will ensure all operations are documented, all materials are verified as correct and all equipment is qualified as fit for purpose.   All this must be in place and operational prior to receiving regulatory approval to manufacture.  This status must be maintained to a standard that ensures consistent replication of all the production processes and without ever compromising the quality of that product.  The maintenance of these standards is called Current Good Manufacturing Practice (cGMP). This qualified or approved state is subject to continuous ministering and inspection by the regulatory authorities involved, as long as the product is in production.


Basic Validation Requirements.

Graphic of the relationship between documents used in validation documentation sequence.

cGMP 211.100.

There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

cGMP 820.70

Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:

(1) Documented instructions, standard operating procedures (SOP's).

(2) Monitoring and control of process parameters.

(3) Compliance with specified reference standards or codes.

(4) The approval of processes and process equipment.

(5) Criteria for quality of workmanship.

Life Cycle Validation Requirements.

A graphic depicting the validation documentaion required for full life cycle validation.


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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.


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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To find a specific document enter full details in Search Box Below. The more defined the search is the more precise the search findings will be.

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When assistance is required; please contact us on TOLL-FREE 877-462-4048

If out of office hours; please leave a voice message.