In validation, there cannot be a qualified “state” unless a qualified “state” has been defined. In cGMP the URS defines this qualified “state” and the execution of the DQ, IQ, OQ and PQ has to be sufficiently rigorous to verify that all the requirements detailed in the URS have been complied with.
Qualification must be executed against a system or entity once it is installed, commissioned and producing product that is of the expected specification. Since all the regulatory requirements are documented, the first action must be to execute a GAP audit to establish your state of compliance. Once your GAP audit indicates you have achieved full compliance - application should be made to your regulatory authority.
The Good Manufacturing Practice (GMP) Requirements are promulgated as regulations enforceable in law. To ensure compliance there are a powerful range of penalties that can be applied to companies and or individuals who; either negligently or willfully fail to comply with all the regulations that are applicable to their activities.
Validation is executed against a system or entity that is installed, commissioned and producing product that is of the expected specification. There must be no adjusting or tweaking to be done; that should have all been completed during commissioning activities. This is the basic methodology used to introduce pupils to the complexities of subjects like regulatory qualification.
The wording of test scripts can be tricky, but you will find that the template author has worded the essentials of the document in clear, concise and unambiguous terms allowing you to relax about such trivia and just press on following the completion instructions.
such documents are reviewed by regulators or visiting auditors, the quality of
the document is obvious and indicates to the reviewer the importance that the
company gives to the quality of it’s documentation.
The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance is being driven by evidence that the industry is failing to match the standards set by other regulated industries.
Jul 30, 18 09:55 AM
Learn how software validation becomes intuitive when third generation 4Q protocols and plans are used. Start with the Validation, Requirements, Risk & Plan (VrrP) and finish with the combined Design I…
Jul 30, 18 08:39 AM
Equipment Qualification or validation requires that risk based, pre-approved bespoke IQ, OQ & PQ protocols are authored & executed to produce tangible evidence that all the requirements listed in the…
Jul 25, 18 08:24 AM
21 CFR Part 11 Compliance verification is built into all our IO's and OQ's. These test scripts along with all other test scipts we use, are available for purchase separately.
Jul 24, 18 12:51 PM
510k. Must define: boundaries, responsibilities, deliverables & requirements. Must specify: life cycle, test scripts, traceability & risk. Must scope: protocols, maintenance & calibration. Must produc…
Process qualification requires the establishment of scientific evidence that the process is capable of consistently delivering product that satisfies all the applicable requirements documented in the User Requirements Specification (URS).
Further to this the process verification should not be viewed as a one-time event, but should be viewed as an ongoing lifecycle requirement. Sampling methodology should become a key factor in carrying out ongoing process qualification.
Current good manufacturing processes (cGMP) regulations specify that samples must: represent the batch under analysis and meet specifications and statistical quality control criteria as conditions of approval and release. Furthermore, the batch must meet its predetermined specifications.
The importance of pharmaceutical process qualification is emphasized by the way the regulators relate all other activities relative to it. Calibration, maintenance, documented procedures, operator training, utility and ancillary service requirements are all defined by the “process”.
Since testing for conformity will usually destroy or damage the product, we are often totally reliant on replicating the process so precisely that the product is produced to the exact efficacy specified.
Process verification ensures that all aspects of the process execution have been subjected to rigorous verification procedures verifying that the product is consistently manufactured to specification.
A company approved Project Quality Plan (VP) must detail the actions, deliverables, responsibilities and scope of qualification activities required for each of the identified VRA ratings. This definition and scope must be built into each Installation Qualification and Operational qualification protocol.
There are two stages of Change Control to be considered, there is the equipment vendor / suppliers control used during manufacture Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and commissioning. Then there is the post qualification control, which ensures that all work carried out on the validated system(s) is reviewed, and the impact of the work carried out on the system’s validated status is assessed.
Written procedures should be in place to describe the actions to be taken when a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducible of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications and original validation.
The vendor must ensure that all changes carried out to the system during manufacture and execution of the SAT, FAT and commissioning testing, have been incorporated into the verification documentation. All drawings must be accurate, signed off, and approved. All traceability between URS documents and design specification must been maintained.
The company must ensure that all changes carried out to the system subsequent to the vendors actions have received approval prior to implementation, and have been fully incorporated into the system validation documentation. That no actions can take place that may compromise the validated state of the system.
For Your Security We are Now TLS 1.2 Compliant
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
This Validation, 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. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. 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.
4Q Equipment Validation 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
validation documentation 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, it is still written in word
This quite unique two
document package is all that is required to fully validate; to cGMP standards,
equipment used in a regulated facility. A lot of effort has gone into ensuring
that repetitive instructions and actions have been designed out and innovative
and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.