GPC/SEC Validation and Qualification
Solutions for GPC/SEC Validation and Qualification
Can the GPC/SEC system measure precise molar mass distribution and averages? A system suitability test (as part of OQ/PV) can answer that question.Validation requires to prove that each process involved in producing a product or result can be shown to be
- doing the right job
- and doing the job right
The validation of analytical systems is not an easy task. Validation is an ongoing complex process that evaluates the entire, sample specific process, products, and analytical methods. Validation consists of several qualification phases that verify pre-defined performance specifications:
- design qualification (DQ),
- installation qualification (IQ),
- operational qualification (OQ),
- and performance qualification (PQ).
Therefore, a one-time qualification event for each component of the analytical system is not sufficient to operate a valid system. System Validation is a frequent requirement: after installation, prior to routine use, after maintenance or repair and at regular time intervals.
Many lab managers associate validation with increased workloads and paper work, because it requires extensive documentation of all testing experiments. However, if the validation process is carefully and thoroughly planned, with
method know-how, it indeed decreases documentation effort
and ensures data integrity, traceability and security.
PSS products and services for GPC/SEC Validation and Qualification
PSS offers validation and qualification services as well as off-the-shelf products to support users during self-performed validation.
All PSS products, from a single GPC/SEC molecular weight standard up to complete systems, come with detailed certificactes and conformity declarations. Each PSS column comes with its individual test certificate showing plate count, resolution and asymmetry for that special column. PSS WinGPC UniChrom software is fully validated and compliant to all national and international GPC/SEC standards. The Compliance Pack for WinGPC UniChrom and all its modules adds electronic records protection for compliance with FDA 21 CFR Part 11.
The PSS turn-key modular GPC/SEC system, based on the SECcurity components, offers built-in compliance features for hard- and software components. As an alternative to the PSS validation service, customers can validate theirs system, methods and data in the shortest possible time and at the lowest cost.
PSS EasyValid, the first true GPC/SEC system suitability test, can be used to validate the SECcurity system, other vendor's systems or even mixed configurations.
Theoretical background GPC/SEC Validation and Qualification
What are the steps of a cost-effective and successful validation?
1) Design qualification (DQ)
DQ is the first and most important step of any qualification process. This step helps to answer the questions: Is the system doing the right job?
For instruments and software this means:
- Documentation of user requirements as well as functional and operational specifications.
- Qualification of the vendor for appropriate development and support processes.
2) Installation qualification (IQ)
IQ helps to qualify the analytical system for correct installation in the customers laboratory.
For instruments and software this means:
- Verification of correct installation of the new hardware and software according to vendor protocols.
- Audit-ready documentation.
3) Operational qualification (OQ)
OQ is the term used in pharmaceutical and FDA environment, in ISO/EN/Accreditation environment the term Performance verification (PV) is used.
OQ/PV helps to qualify the analytical system for correct operation in the customers laboratory.
For instruments and software this means:
- Verification of correct operation of the new hardware and software according to vendor protocols.
- Audit-ready documentation.
IQ and OQ/PV help to answer the question: Is the system doing the job right?
4) Performance qualification (PQ)
PQ helps to keep laboratory productivity high.
For instruments and software this means:
- Monitoring critical chromatographic performance parameters for GPC/SEC.
- Automated self-verification routines.
- Monitoring instrument parameters to schedule timely preventive maintenance before an instrument error occurs.
- Audit-ready documentation.
5) Method validation
Analytical methods must be validated after their development and before routine use. If any parameter is changed significantly, revalidation of the method is required. National and international standards and interpretation guides, such as those issued by the United States Pharmacopeia (USP), the European Pharmacopeia (EP) and the International Conference on Harmonization (ICH) organizations, specify parameters for method validation.
What are the main requirements of 21CFR part 11 for electronic records and electronic signatures?
For customers working in an FDA regulated environment, it is necessary that the software is compliant with regulations adopted by the FDA. These regulations are contained in the Code of Federal Regulations (CFR), Title 21, Part 11, and are entitled “Electronic Records; Electronic Signatures”. These rules change significantly the treatment of computer-generated data. The main goal of this rule is securing the authenticity of the generated analytical data and protection against unauthorized disclosure, unintentional error and intentional fraud.
There are several requirements that help to achieve the goal:
- secure login with username and password
- access levels (customizable) appropriate for each user
- time-stamped audit trails to independently record all actions
- electronic signatures
All requirements of 21CFRpart 11 are met with the WinGPC Unity Compliance Pack.