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Verification and validation is the process of checking that a product, service, or system meets specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9001. Sometimes preceded with "Independent" (or IV&V) to ensure the validation is performed by a disinterested third party.

Apex Machine Company has worked with many major manufacturers of medical and pharmaceutical products and is thoroughly conversant with the requirements and procedures for IQ, PQ and OQ related to the verification and validation of product handling, printing and vision inspection equipment. Our in-house specialist department is available to assist customers with the validation processes, documentation and specifications.

Some general information about verification and validation processes is outlined below, together with some links to relevant items of interest or reference.

Terminology

Verification is a quality process that is used to evaluate whether or not a product, service, or system complies with a regulation, specification, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.

Validation is the process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.

It is sometimes said that validation can be expressed by the query ‘Are you building the right thing?’ and verification by ‘Are you building the thing right?’. 'Building the right thing' refers back to the user's needs, while 'building the thing right' checks that the documented development process was followed. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

Activities

Verification of machinery and equipment usually consists of Design Qualification - DQ, Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ.

DQ is usually the vendor's job. However, DQ can also be performed by the user, by confirming through review and testing that the equipment meets the written acquisition specification. If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment. Otherwise, the process of IQ, OQ and PQ is the task of validation.

Qualification of machinery/equipment is venue dependent and re-qualification needs to be conducted once the objects are relocated. The full scales of some equipment qualifications are even time dependent, and hence re-certification is necessary when a specified due time elapses. Re-qualification of machinery/equipment should also be conducted when replacement of parts, or coupling with another device, or installing a new application software and restructuring of the computer which affects especially the pre-settings, such as on BIOS, registry, disk drive partition table, or an ini file etc, have been necessary. In such a situation, the specifications of the parts/devices/software and restructuring proposals should be appended to the qualification document whether the parts/devices/software are genuine or not.

When machinery/equipment qualification is conducted by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the process is called certification.

Categories and aspects of validation

Validation work can generally be categorized by the following functions:

Prospective validation - the missions conducted before new items are released to make sure the characteristics of the interests which are functional properly and which meet the safety standards. Some examples could be legislative rules, guidelines or proposals, methods, theories/hypothesis/models, products and services.

Retrospective validation - a process for items that are already in use and distribution or production. The validation is performed against the written specifications or pre-determined expectations, based upon their historical data/evidences that are documented/recorded. If any critical data is missing, then the work can not be processed or can only be completed partially. The tasks are considered necessary if :

  • prospective validation is missing, inadequate or flawed;
  • the change of legislative regulations or standards affects the compliance of the items being released to the public or market;
  • reviving of out-of-use items.

Full scale validation

Partial validation - often used for research and pilot studies if time is constrained. The most important and significant effects are tested.

Cross-validation

Re-validation/Locational or Periodical validation - carried out, for the item of interest that is dismissed, repaired, integrated/coupled, relocated, or after a specified time laps. Examples of this category could be relicencing/renewing operator's license, recertifying an analytical balance that has been expired or relocated, and even revalidating professionals. Re-validation may also be conducted when/where the changes, for example of sample matrices, production scales, or population profiles and sizes, occur during the courses of activities such as scientific researches or phases of clinical trial transitions. In GLP accredited laboratories, verification/revalidation will even be conducted very often against the monographes of USP and BP to cater for domestic needs.

Concurrent validation - conducted during a routine processing of services, manufacturing or engineering, etc. Example of these could be duplicated sample analysis, single sample analysis with multiplicated online system suitability testings. The most tested attributes in the validation tasks may include:

  • Selectivity/specificity
  • Accuracy
  • Precision/Repeatability
  • Reproducibility
  • Curve fitting

System suitability - In a broad way, it usually includes a test of ruggedness among inter-collaborators, or a test of robustness within an organization. However, the FDA has specifically defined it for its administration, as "System suitability testing is an integral part of many analytical procedures. The tests are based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated." A good example is provided by the company GMP ONLINE CONSULTANCY and the test requires certified standards if a compendial method is to be used.

Industry references

Terms generally apply broadly across industries and institutions. In addition, they may have very specific meanings and requirements for specific products, regulations, and industries.

Food and Drug

Pharmaceuticals The design, production, and distribution of drugs are highly regulated. This includes software systems. For example in the USA, the Food and Drug Administration have regulations in Part 21 of the Code of Federal Regulations. Nash et al. have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes. Some companies are taking a risk-based approach to validating their GAMP system if one understands the regulatory requirements very well while most others follow the conventional process. It is a part of GxP management.

Medical devices The FDA (21 CFR) has validation and verification requirements for medical devices.

ISO 13485
Manufacturing process and cleaning validation are compulsory and regulated by FDA.

Links & References

 

 

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