All applicable GMP calibration requirements should be encapsulated within a company approved Calibration Management Practices and Procedures manual. Routine and snap quality
audits must be used to confirm past, present and anticipate future compliance. The historic records establish with a calibration manager program are essential in facilitating accurate predictive forecasting of any instrument error propagation.
GMP regulated companies often use contract laboratories to satisfy their cGMP calibration reference their measurement and test equipment. If this is the case, FDA views the contract laboratory as an extension of the manufacturer's GMP program or quality system.
Normally FDA does not inspect contract laboratory facilities, but it does expect the manufacturer to audit the contract lab to verify that proper procedures are being used. Generally, the manufacturer of the finished device is responsible for assuring that all GMP calibration requirements are being complied with. This puts the onus on any auditor to ask about validation and calibration methodologies, techniques and standards used.
21 CFR Part 820 and 210 mandates that where the accuracy of instruments and or instrument sensors is judged as critical to the final efficacy, quality and or safety of a regulated product or could prove injurious to the integrity of any associated predicated data or data records; the individual instrument must be considered as a, “Critical Instrument”. Critical instruments must be entered into a planned calibration program and subjected to routine calibration against master instruments traceable to national standards, at a periodicity that has a written justification. They must be placarded with a “Calibrated Label”. This SOP lists, details and defines each of the 11 essential elements of cGMP compliant calibration and calibration management. It includes sample document formats, calibration labels layouts and details the importance of the post calibration report. The SOP concludes with a fully detailed; ready to use, Calibration Manager Auditor document. This is your complete calibration SOP to purchase and use.
9001:2000, requirements must be incorporated into each manufacturer's measuring instruments manager program and form the basis of its quality controlling activities and used to ensure that all calibration delinquencies are removed from existing procedures. A good program can do more than reduce scrap rates. It can reduce expenditures for measurement instruments and related services, add to the confidence and expertise of the company’s staff,
and increase the customer's perception of company performance. A good program can protect the company from both routine and more subtle calibration delinquencies and provide records of internationally standardized metrology that would be hard to dispute.
Measurement instruments and tools differ greatly in construction and intent, and the specific activities necessary to calibrate these tools are just as varied. An understanding of the operation of each tool allows problems to be detected, adjustments to be made properly, and condition of tools to be assessed. These technical details are found in all good metrology procedures.
These procedures, to be effective, have to be valid to the tool that will be calibrated. It is very important for a manufacturer to design its metrology procedures around the specific tools and how they will be used to ensure calibration delinquencies do not arise.
There are many sources of historically validated metrology procedures for dimensional metrology tools.
The manufacturers of dimensional metrology tools can also be a great source of valid, proven measuring instruments. Metrology laboratories used for these services may be willing to share their procedures.
Staff experience can also be an excellent source of data on measuring instruments calibration manager procedures.
Traceability of a measurement unit is really maintained by a dual chain of metrology that goes back to the international standard. Each comparison is accompanied by an estimation of measurement uncertainty. Measurement uncertainty is calculated through an internationally standardized discipline.
The requirements for measuring instruments calibration manager documented procedures for the control of measurement tools can be found in section 7.6 of ISO 9001:2000. For insight into this section, it is useful to refer to the manufacturing centered 1994 version of ISO 9000. Section 4.11, Control of Inspection, Measuring, and Test Equipment states that measuring equipment is used in a manner that ensures that the measurement uncertainty is known and is consistent with the required measurement capability. The intent of the requirements in both versions is the same. In-house calibrations that are not accompanied by calibration delinquencies have broken the chain of traceability.
An GMP calibration requirements management system strives to attain
customer satisfaction through maintaining all sensory systems used in
the manufacturing and testing of a regulatory controlled product
operating within their design specification.
The management of GMP calibration requirements management system is accomplished in the same way as management of the other processes identified in the manufacturer’s management system. This manager program must also log calibration delinquencies that arise to allow predictive analysis of any instrumentation errors.
Some manufacturers may choose to develop a system manual which contains the process description, planned quality objectives, key indicators of process performance and references to the standards and procedures in use. This can become a very valuable document that serves as the road-map to a dynamic and effective, GMP calibration requirements solution.
1: There must be a documented justification for CI classification.
2: All CI’s must be calibrated prior to use.
3: There must be a documented justification for CI calibration periodicities.
4: Calibrate within design Specification.
5: Unique serial numbers log must be established for CI’s.
6: Critical parameters must be obtained from calibrated CI sensors.
7. Calibrated & Non calibrated sensors must be appropriately placarded.
8. Adjusters that affect calibration; must be sealed against illegal use.
9: Completed CR must be circulated to an approved list of recipients.
10. Software associated with CI ‘s must be validated appropriately.
11. Calibration Management system must regularly audited.
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21 CFR Part 820 and 211 mandates that where the accuracy of instruments and or instrument sensors is judged as critical to the final efficacy, quality and or safety of a regulated productor could prove injurious to the integrity of any associated predicated data oror data records; the individual instrument must be considered as a "Critical Instrument" (CI). A calendar based re-calibration schedule must be established to ensure the accuracy of all such instrumentation is continually verified. Trend analysis techniques must be used to determine that the time between calibrations (TBC) chosen; ensures that recalibration is scheduled well before the accuracy of the instrument or sensor could jeopardize any predicated process parameters.
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 is interactive, easy to use and
suitable for all mixes of equipment with and without software.
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 intentions 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 URS.
The Process Validation or 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 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.
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 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 & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/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 Manual.
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%. The new bang up to date 4Q protocol replaces the DQ, 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.