Home
Contact Details DOCUMENT SHOP
Introduction.
Doc Applications
Validation Enquiry
Site Statistics
Site Problems
Phone; 703-9035
 Free Newsletter
Contact Us Directly.
Linked Sites
Protocols & Plans: Agency Reviewed
Autoclave Validate
Computer Validation (CV)
Combined IQ-OQ-PQ
Compressed Air Val
Computer Vendor Audit
Design Qualification
Facility Qualification
HVAC Qualification
Combined_IQ-OQ
IQ OQ PQ Protocols
Installation Qualify
LAN Validation
Operation Qualify
Performance Qualify
Process Qualification
Spreadsheet Validat
Software Validation
Steam Quality
Temp. Mapping
User Requirements
Validation Plans.
Val. Master Plans
Validation Packages
Procedural Docs: FMEA for Bio-Med
Gap Analysis Tool
cGMP
Predicate Rules
Risk Assessment
SOP for SOP
SOP for cGMP Rev
SOP Validation
Validation Matrix
Vender Audit.
Hard Ware/Copy BSI Standards
Contracted Validate
Data Loggers
Ear Wax Removal
Fridge Guard
Quality Manual (CQM)
Humidity Calibration
Validation Manual (CVM)
Tele Conference
Technical Info: Calibration
CSV Annex 11
Free Vendor Audit
GAMP 5
Glossary
GMP (cGMP's)
GMP Problems.
Hardware Validation
Med Devise Validate
Mixing
21 CFR Part 11
Part 11 Update
Pharma Maint'ance
Protocol Standards
Validation Protocols.
Validation Blog
Video News
Retro-Validation
Warning Letters
Your Free Glossary
General Info: Calculators For All
Conditions of Use
Corpus Clock
Customer List
Easy Business
house
Procedures
Product for License
Regulatory Authorities
Scottish Gifts
Document Shop

OPERATIONAL QUALIFICATION (OQ)



Operational Qualification Rationale.

This Operational Qualification (OQ) protocol comes with an interactive SOP as a prefixed document. As you complete the SOP you are auto populating the OQ. A really easy and straight forward document to use. In the preparation of the Operational Qualification validation protocols, it is important to allow a degree of flexibility. This must and should be specified in the Validation Plan (VP). Should the OQ remain untouchable until the Installation-Qualification (IQ) is completed and signed off? There are many instances where this is not just undesirable but senseless and deleterious to project progress and costs. Should every function in a system or piece of equipment be qualified? It makes little sense to fail something for not reaching a parameter that you are not going to use. The Operational Qualification includes a review of the Standard Operating Procedure (SOP's) for start-up, operation, maintenance, safety, and cleaning / sanitization as applicable, must they be in fully approved format? These flexibilities must be built into the qualification process. However there is an abundance of rules and guidelines that are not flexible, and must be rigorously adhered to. The modular process has been followed in constructing this Operational Qualification, in as much that where tests / inspections are standard for systems and or equipment, they are built into the basic protocol. Where they are not they are available as test protocols. Functional and software tests are authored in this stand alone test scrip protocol format. When the OQ is being raised they are pasted in. The document format will paginate them, and automatically add them to the ‘Table of Contents’. They are then part of the OQ. These Test Scripts can be held as Method Statements or SOP's. This allows the generation of a standard OQ that covers all the many items the regulators are looking for, with the facility to have integrated into it, the equipment specific testing tasks. It also means that these stand alone test scripts are available for tasks other than validation, i.e. when system re-testing is required.


One of the advertisers on this site has a completely free credit on offer, it really is to good to miss out on.

It also saves unnecessary testing and re-testing. For example, when a room pressure regime has been commissioned by another party and the completed report is in date and available, is it practical and legal to use it? There is no reason why not, providing it has been authored, and executed using the same documentation practices and procedures as are used in the routine production and execution of validation protocols. The OQ test scrip will be of standard format, the contractors tests (containing the raw data) will be reviewed and data extracted from it. This data will be used to verify that the Operational Qualification test script acceptance criteria has or has not been satisfied. The raw data from the contactor now forms part of the OQ, and must be appended to it permanently, along with copy calibration certificates for all the test equipment used in obtaining the raw data.
Where you use your own indigenous testing methods contained in an SOP or a Method Statement (or whatever you decide to call them), they must be used in a manner similar to the manner the contractors raw data was used.






OQ Scope.

The scope of the OQ testing/inspections must include but is not limited to:

  • Verification that all loop installations;
  • Insert a brief description of what part of the validated product process.
  • Insert a brief description of the operational function.
  • An integrated loop test verification.
  • Testing of alarms.
  • Testing of interlocks and permissive conditions.
  • Testing of database or data storage integrity.
  • Testing of report generation and event chronicle.
  • Verification of the functionality of the equipment.
  • Challenge of software, where required;
  • Review of system functionality to verify compliance with 21 CFR Part 11.
  • If system must be 21 CFR Part 11 compliant, verification;
  • Testing of security levels to prevent;
  • Testing to verify and document Power loss Recovery.
  • Testing of all interfaces between;
  • Testing for Electromagnetic interference and compatibility.

    Full Life Cycle Documentation.


    OPERATIONAL QUALIFICATION.



    footer for operational qualification page