SOP For manufacturing discrepancy and investigation report is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure is followed when investigating and reporting a material or production discrepancy; or when a discrepancy in standard operating procedure is observed.

SCOPE

This SOP is applicable to Quality Assurance, Warehouse, Quality Control, Maintenance and Production departments.

RESPONSIBILITY

Manager Quality Assurance

Manager Quality Control

Manager Production

DEFINITIONS

Manufacturing Discrepancy is a serious problem, which occurs during the manufacturing, packaging, or testing of a pharmaceutical products. This problem is considered:

  • Major in magnitude
  • Likely to affect product quality
  • May result in additional costs / losses
  • Could have potential regulatory effects

Manufacturing Discrepancy & Investigational Report (MDIR) is the reporting and investigational system to be used to document material or production discrepancies as described in this procedure.

Product or material deviations from standards are minor variations from established standards or specifications. Deviations are generally:

  • Minor in magnitude
  • Unlikely to affect product quality
  • Unlikely to result in additional costs / losses
  • Unlikely to result in regulatory effects
  • Approvable by Quality Assurance Manager alone

GENERAL

Discrepancies occurring during production (manufacturing and packaging areas) or testing that could affect the identity, assay, quality, purity or safety of the product are investigated and records maintained.

Discrepancies include (but are not limited to):

  • Abnormal reconciliation (yields exceeding normal tolerances).
  • Uneven distribution of API
  • Major color variation after coating or in packing components  
  • Weight variation 
  • Sealing problems.
  • Missing of units /empty strip/vial/ampoules
  • Batch mixing 
  • Wrong batch coding i.e. Batch No., Mfg. Date, Exp. Date, MRP.Rs. etc 
  • Wrong issuance of material
  • Labelling or circular (packaging insert) errors.
  • Processing or formulation errors.
  • Product contamination.
  • Mixed or incorrect product, product containers, or closures.
  • Discovery of foreign product labelling or packaging materials during or after a packaging run.
  • Failure to meet specifications, which leads to rejection of the product.
  • Equipment failure, which may affect product quality or efficacy.
  • Loss of batch records or any portion thereof.

NOTE: Variations that are considered as expected process variations and are covered by a standard operating procedure are not considered manufacturing discrepancies that require an MDIR. of products and materials covered under the "Analyses and release of raw materials, intermediates and finished products and record keeping". Procedure does not normally require an MDIR. Examples of deviations include:

  • Product or material pH or moisture content slightly out of specification.
  • Minor color difference in product or material.
  • Cosmetic defect in labelling (smudge, slightly off color of print).

PROCEDURE

The suspect raw material, packaging component (container, closure or label), or product is placed under "HOLD" status (quarantine) by QAD until this investigation is completed.

In addition, any suspect equipment cannot be used until authorized by full sign off of the MDIR. After the investigation carried by QAM, the component/product is rejected, released without restriction, or released with restriction, depending upon the results of the investigation.

The discrepancy is investigated by responsible departments and an investigation report will be issued.

This report should include an explanation of the problem and the batch history, the results of the investigation and the corrective action taken and results and the final disposition. The department where the discrepancy occurred has the responsibility for initiating the report.

The investigation is extended to other batches of the same component or product and to other components or products that may have been associated with the specific failure.

Any action taken must address the corrective action taken to resolve the immediate problem and the action taken to avoid a similar problem in the future.

In case of major deviation the Plant Manager, Quality Assurance Manager and Quality Control Manager will   review, approve and sign on investigation report. Quality Assurance /Q.C. Manager or HOD signature is required whether reprocessing or remixing is required.

The MDIR form is completed and maintained with product batch records.