Quality Oversight – an USFDA warning letter
U.S. Food and Drug Administration issued a warning letter to the Chinese Drug Manufacturing facility where Inspector found Oversight concerning the Quality. There are numbers of pharmaceutical industries received FDA 483s and USFDA warning letter, import alert to neglect the quality system w.r.t. current good manufacturing practices (cGMP), it’s a continuing problem in the pharmaceutical industry.
In this current warning letter, U.S. FDA inspector has observed lots of issues w.r.t. violation of cGMP and several examples of quality oversight resulted in Import alert in their conclusion.
Quality oversight examples are listed below:
- The firm failed to maintain written production control, analytical documents specifically associated with the batch of a drug product.
The site should have a document control and storage policy and procedure to ensure the availability of all the batch documents, analytical documents, and another document-related batch of drug products. At-least all such batch related documents should have minimum storage one year after subjected drug batch expiry. All other documents related to batches like Raw material, Packing material testing records, and the analytical record should also keep after one year of batch expiry.
- Full testing of a drug product and their review.
A review mechanism is required to ensure the accuracy, correctness of the analytical data before the release of the product in the market. There should be a review and approve procedure to double ensure the accuracy, correctness of analytical results of drug products against predefined and approved specification limits.
- Cleaning validation of shared equipment
A cleaning validation policy should be in place and any new molecule addition in the shared facility, equipment should be handled through proper risk assessment. A worst-case molecule should be selected basis solubility, potency, dose criteria, toxicity, and PDE (Permitted Daily Exposure) value (new approach in cleaning validation) of a molecule and accordingly, a cleaning validation study should be performed. The following are the prerequisites for cleaning validation.
– The shared surface area of the equipment
– Recovery study of the swab
– Method validation to decide LOQ (Limit of Quantification) & LOD (Limit of detection) of the worst molecule.
– Cleaning validation matrix to identify the worst-case molecule
– Approved cleaning validation protocol to execute the activity etc.
- A written procedure for sampling and testing not followed
Any departure from the approved and written instruction should be handled through deviation procedure to understand the extent of the failure and further impact analysis.
- Data Integrity Remediation as the quality system does not adequately ensure the integrity and accuracy of data to support the safety and the efficacy of drug products.
Data integrity breach is a hot topic in the pharmaceutical and healthcare industries and most of the data integrity breach is observed in the quality control laboratory. To assess the possibility of data integrity breach in laboratory, manufacturing, and associated all other utilities and other activities that are involved in GMP should be review against a predefined checklist and actions should be decided based on risk assessment. For the data integrity assessment of HPLC see the below link.
To read this complete warning letter see below link
U.S. FDA Warning letter (Website: https://www.fda.gov)