Are You Properly Storing Batch Records?

A recent FDA inspection at a pharmaceutical manufacturing facility revealed serious deficiencies in the firm’s retention and control of critical batch production records.

According to the Code of Federal Regulations section 21 CRF 211.180 General Requirements, any record required to be maintained should be retained for at least 1 year after the expiration date of the batch.

Retention of batch production and control records are deficient

Specifically, the firm’s storage or security of completed manufacturing batch records was inadequate in that the records were identified as being stored on open shelving units and on manufacturing personnel desks. The firm has documented the following deviation investigations in which sections of manufacturing batch records or GMP records were missing:

a.DEV …-Initiated for missing single page of batch record … and missing seven pages of batch record ..

b.DEV …-Initiated for missing single page of batch record …

c.DEV …-Initiated for missing QA Label Verification Form and QA Clearance Checklist Form.

d.DEV …-Initiated for missing Observation Sheet for batch record …f.DEV …-Initiated for missing Synthesis Solution section … `of the batch records

Inspectors found that the company was storing completed batch manufacturing records on open shelving units and personnel desks throughout the facility. This unsecured storage left the vital GMP records vulnerable to loss or mix-ups.

Even more concerning, the inspection uncovered multiple instances where sections of batch records and GMP documentation had gone missing entirely. The FDA’s Form 483 cited several recent deviation investigations initiated due to pages missing from batch records, including:

  • Missing single pages from two separate batch records
  • Seven missing pages from another batch record
  • Missing QA Label Verification and QA Clearance Checklist forms
  • A missing Observation Sheet
  • The entire Synthesis Solution section missing from a batch record

Complete and secure retention of batch records is a fundamental GMP requirement to assure drug quality and integrity. Batch records serve as the official history of each manufactured drug, documenting step-by-step the materials, processes, in-process controls, lab testing and results guaranteeing the batch met all specifications.

By storing official records haphazardly and losing sections of batch documentation, this firm lacked basic control over its manufacturing records. The potential for mix-ups, errors, or data omissions that could impact drug safety is unacceptable.

FDA-regulated companies must establish proper procedures to ensure batch records are properly organized, retained, and secured at all times during manufacturing and after distribution. Electronic systems, secure file rooms, and rigid chain of custody are often employed to safeguard these essential records.

Failure to maintain complete batch records leaves critical gaps in production histories and raises uncertainties about drug quality – violating the essence of current Good Manufacturing Practices. As this warning underscores, FDA has zero tolerance when firms fail to properly control their batch records.

Our new Issue 1135, available today, includes additional observations on laboratory controls, as well as observations on quality systems, manufacturing controls, and water systems.

To view more observations pertaining to record storage and retention refer to the following GMP Trends® Issues: 1113110210881086 .

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