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Nandita Vijay, Bengaluru May 21 , 2022
Indian pharma sees relevance in US FDA norms on Investigating Out-of Specification (OOS) test results for manufacture specifically for contract research and manufacturing services (CRAMS) besides in-house manufacture. The OOS results includes all test outcomes that fall outside the acceptance criteria established in drug applications, drug master files (DMFs) by the manufacturer.

It also applies to all in-process laboratory tests that are outside of established specifications. This guidance applies to chemistry-based laboratory testing of drugs, traditional drug testing and release methods.

These laboratory tests are performed on active pharmaceutical ingredients (APIs), excipients in-process materials, and finished drug products to the extent that current good manufacturing practice (CGMP) regulations apply.

The principles in this guidance also apply to in-house testing of drug product components that are purchased by the company

This guidance can also be used by contract firms performing production and/or laboratory testing responsibilities.

Specifically, the guidance discusses how to investigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results. Laboratory testing, which is required by the CGMP regulations is necessary to confirm that components, containers and closures, in-process materials, and finished products conform to specifications, including stability specifications.

According to the industry experts, India is a CRAMS hub and therefore this guidance makes considerable relevance.

Further adhering to these regulations will give Indian companies an edge in the global market for CRAMS. The regulatory authority stated that these regulations provide for the establishment of scientifically sound and appropriate specifications, standards, and test procedures that are designed to ensure that components, containers and closures, in-process materials, and finished drug products conform to the established standards.

Current good manufacturing practice for APIs includes the performance of scientifically sound raw material testing, in-process monitoring, release and stability testing, process validation, and adequate investigations of any OOS result obtained from such testing. The purpose of the investigation is to determine the cause of the OOS result. The source of the OOS result should be identified either as an aberration of the measurement process or an aberration of the manufacturing process.

Even if a batch is rejected based on an OOS result, the investigation is necessary to determine if the result is associated with other batches of the same drug product or other products. Batch rejection does not negate the need to perform the investigation. The regulations require that a written record of the investigation be made this way, hypotheses regarding laboratory error or instrument malfunctions can be tested using the same test preparations.

If this initial assessment indicates that no causative errors were made in the analytical method used to arrive at the data, a full-scale OOS investigation should be conducted.

 The first responsibility for achieving accurate laboratory testing results lies with the analyst who is performing the test. The analyst should be aware of potential problems that could occur during the testing process and should watch for issues that could create inaccurate results, emphasised the regulator.

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