Starting from the top of the diagram on the left and working downwards, the functions of the various sections are explained here in greater detail:
Generic Audit Q&A.
This contains all the answers to the most commonly asked questions concerning Malvern’s change control and Quality systems. It has been distilled from a wide cross-section of customer’s vendor appraisal questionnaires and, by giving fuller answers than some questionnaires allow in a fraction of the normal timescale for the completion of individual questionnaires, allows the validation process to commence without delay.
Guide to Risk Analysis of laser diffraction particle sizing methods.
Since the whole validation process is based on a risk analysis relating to the possible impact of failures on products and patients, this document gives useful guidance to help users to assess the risk areas for their particular products.
Guide to verification of laser diffraction particle size analyzers.
Many Quality Assurance validation specialists are familiar with the requirements for the validation of chromatography-based analysis systems but are less familiar with validating laser diffraction-based particle size analyzers which are based on a different set of physical principles and therefore differ in many important respects.
This section examines these differences and their significance in terms of Validation procedures.
User requirements Specification Matrix
One of the foundation stones of any Validation plan is the production of a User Requirements Specification. This matrix provides users with a detailed specification describing the Mastersizer 2000 and its capabilities.
The matrix includes realistic pass/fail criteria that can form the basis of a User Performance Qualification and/or a user functional specification and, ultimately, the PQ specification.
It is included as an electronic file on the CD supplied with the binder to enable users to cut and paste relevant sections to their own documents.
PQ Advice
Different companies have different interpretations of the nature and scope of the Performance Qualification process.
In many companies, its function is seen as being a once-for-all confidence-building process to establish that the system can perform the full range of measurements required.
However, Performance Qualification should include an ongoing program of regular checks to ensure that the system’s performance continues to comply with the user’s requirements.
The full suite of IQ/OQ documentation for the Mastersizer 2000 and the sample dispersion units.
Many users’ Quality Assurance departments are required to assess suppliers IQ/OQ documentation before allowing the supplier’s technical representatives onto their site to carry out the installation of the equipment.
This section includes the IQ and OQ documentation for the Mastersizer 2000 Optical Unit and the following sample dispersion units used by the pharmaceutical industry:
- Scirocco Dry powder feeder
- Hydro S Automated small volume sample dispersion unit
- Hydro SM Manual small volume sample dispersion unit
- Hydro μP Micro volume sample dispersion unit
Also included are specimen copies of the Performance Verification Certificate for these Units, together with the OQ Certificate for the Optical Unit.
The inclusion of this section helps to expedite the review process and ensure that the installation can proceed at an early date.
Software Certificate of Conformance.
This Certificate, which relates to the latest version of the Mastersizer 2000 software at the time of issue, certifies that the software has been developed, tested and released in conformance with Malvern Instruments ISO9000: 2001 and TickIt Compliance Procedures and lists the procedures and protocols that have been followed.
(Note that It cannot be a validation certificate since the ultimate responsibility for the validation of the software rests with the user.)
Software upgrade verification
This is a written procedure that users can follow to confirm the ongoing numerical integrity of new versions of software as they are released. It uses measurements of Malvern Quality Audit Standards to check that data continues to be saved and printed out correctly as well as confirming that the same results are produced by the new version of software.
An electronic copy of this procedure is included on the CD supplied as part of MAL2140 .
Numerical Validation of the software
This section includes a copy of the paper “Mastersizer 2000 Data and Result Validation” describing the use of Excel as a peer program to carry out numerical Validation of the software.
Also included is a verification spreadsheet to confirm the correctness of the percentiles and the undersize values within the software by simple linear interpolation.
This spreadsheet is also included on the CD supplied with MAL2140 to enable users to carry out this validation check if required.
21 CFR Part 11 compliance evaluation documentation and user advice
This section includes:
- Point-by-point comparison with each clause of 21 CFR Part 11 describing how the FDA’s requirements are met.
- Advice on security, setting up directories and assigning User Permissions
- A Test Script for users to check the 21 CFR Part 11-compliant features of the software. Based on the original Alpha Test of the software, this lists all the features offered to give users technical compliance with the requirements of 21 CFR Part 11 as well as detailing the tests that have been applied so that users can repeat them if required.
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