PQ is a method-related operation that the analyst performs. Many instruments can be on hold pending the formal qualification.
Outsourcing can be an alternative to speeding the qualification process.
Validation is documented testing, performed under highly controlled conditions, and demonstrates a process that consistently
produces a result that meets predetermined acceptance criteria. In a validated process, it is possible to retest the system
and obtain conformance to specification. Revalidation is performed at periodic intervals or when a validated system is changed
(e.g., relocation or a software upgrade). All computer-associated systems should have defined storage capacity and regular
and emergency back-up procedures that are defined during validation. The system should be challenged for accurate data transfer,
data retrieval, and integrity.
Calibration is performed for process and system monitoring and control. Instruments differ in their calibration frequency
based on their use. The written procedures should include the elements of calibration intervals, accuracy limits, and remedial
actions if the system does not meet established requirements. Periodic preventive maintenance is vital to ensure that all
processes operate in their validated state.2
Documentation reflects how a product is produced, tested, packaged, and stored. Procedures are designed for controlled assessment
and implementation of planned changes. Each document should be uniquely identified and readily available. Documentation SOPs
are developed using regulatory requirements as a minimum standard, and reviewed to ensure that regulations are met or exceeded.
Procedures should be written clearly for all operations and reflect actual practice. Procedures should also adequately govern
the quality and integrity of the data. SOPs have to be properly authorized and dated, and periodically reviewed for current
applicability and changing regulatory requirements All operations are to be carried out in compliance to the current SOP version.
Laboratory documentation and records must be current, permanent, legible, accurate, clear, consistent, and complete. Any work
not documented is considered not performed. Laboratory records should focus on both the 'what' and 'how' of data capture.
Formal checks should be in place to challenge the accuracy and integrity of the written record. The analyst and reviewer must
review, sign, and countersign the written record. Electronic records should be created and stored. A carefully prepared record
allows for re-creation of an event in case of an investigation.
Materials and Methods
The quality and acceptability of raw materials, reagents, and solutions must be described and verified at the time of receipt
and use. The identity and concentration of reagents should be documented and labeled. Storage requirements and expiration
are to be documented and followed. Primary and back-up suppliers for all materials or equipment being used in any cGMP operation
must be qualified and approved.
Equivalent alternates should be provided for specific branded products used in methods or procedures. This prevents the need
to requalify if a manufacturer is unable to provide a required reagent.
Accountability should be maintained for all test and control articles by documenting the transfer of samples from the point
of collection to the test facility. Proper labels should be used to identify the product, batch number, tracking number, label
claim, and storage condition.2
Procedures should ensure that the distribution, storage, and handling of all test articles prevent contamination and deterioration.4 Storage containers should be appropriately labeled and assigned. Reserve samples of test and control articles must be retained
for at least one stability time point after the completion of the study. Test and control articles should be maintained under
proper environmental conditions. At any point, the actual amounts of product in inventory and the accountability records should
reconcile with one another to ensure the integrity of the sample custody. Analytical laboratory personnel must document receipt
of all test articles. The test article should be properly stored and segregated, based on its status during incoming, testing
in progress, and testing completed. Procedures should be in place, applicable, and followed for characterization and stability
testing of article. The testing required will depend on the process and the intended uses of the product, and may be applied
during in-process, bulk, release, or stability.