Does the entire batch have to be destroyed if it does not meet pre-defined specifications?

Even if the process is validated, the equipment is qualified, the in-process parameters are controlled, etc., there may be times when the drug doesn’t meet the pre-defined specifications. Facing these unexpected results, drugmakers often have the products reprocessed or reworked instead of destroying them to minimize the cost loss.

What is Reprocessing?

Reprocessing is re-introducing an intermediate or a batch of products into a validated manufacturing process that did not meet the requirements of earlier stages. All the steps (filtering, drying, or mixing granules) are redone as a normal process to meet the quality standards.

Reprocessing can only be performed if:

  • The finished product quality may not be affected.
  • Reprocess process must be identified in the regulatory dossier as a reprocessing operation.

Reprocessing is considered part of the batch deviation, leading to the compulsory completion of deviation reports, risk assessment reports, etc…

What is Reworking?

Reworking is a process of treating a non-conforming intermediate or product using a new process that differs from the current manufacturing process to obtain acceptable products. For example, adding additional purification, using another method for drying or mixing granules, etc.

The differences between Reprocessing and Reworking

Reprocessing and reworking are considered part of the deviation (non-routine events) that require the assessment of product quality and GMP requirements. However, it has significant differences:

  • It is acceptable if the reprocessing is performed increasingly or repeated frequently, and reprocessing can be registered and updated in the manufacturing process and batch records. Meanwhile, reworking is only executed in an unexpected operation that cannot be pre-approved in marketing authorization.
  • Stability studies must be carried out strictly on a representative number of reworked batches.
  • Reworking undesirable products are only performed in exceptional conditions after having cause identification, risk assessment, and saving related documents.

REFERENCES:

Reprocessing and Reworking – From Confusion to Clarity

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