5-major Laboratory Mistakes that may lead to Noncompliance
- Analytical method mistakes
- In these criteria major cases include:
- Failure for the analytical methods to demonstrate stability.
- Inefficient or failure to include documentations for deviations or investigations.
- Improper use of specifications which does not incorporate critical quality attributes.
- Failure to incorporate Quality by Design Approach in Product development
- Employing and implementing quality-by-design can ensure compliance in the laboratory.
- Management should effectively use quality by design approach in product development and should be able demonstrate to the FDA inspector.
- Inefficient Analytical Methods
- As analytical techniques advances, regulatory agencies expects more advanced methods which demonstrate more accuracy, transparency and less cumbersome. Failure to incorporate these changes could result in deficiency letters.
- Non GLP work in Regulatory laboratory.
- All equipments should be kept in calibration, appropriate records such as history record, service and maintenance records should be updated in timely manner and cross checked by supervisor.
- Every equipment should have clear status label to demonstrate current status of the instrument such as whether the equipment is calibrated or not or under calibration or under maintenance
- Supplier/Vendor Audits
- One of the primary duties of quality assurance department is to ensure that the vendor/supplier should follow compliance and should abide the ICH quality guideline.
- To ensure that a vendor/supplier follows all the regulatory requirements, vendor audit should be conducted.
- Quality agreements should be in place to define the roles of both organizations. (updated on 8.10.2020)