Contract Manufacturing Organization Hit With cGMP Warning Letter

Contract Manufacturing Organization Hit With cGMP Warning Letter

April 18th, 2013 // 5:56 pm @

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A Canadian branch of the largest CMO in India was hit with a GMP warning letter this month because it did not investigate failed product batches or implement CAPAs.

Jubilant HollisterStier, which is a subsidiary of Jubilant Life Sciences based in India, failed to follow cGMP guidelines in these areas:

  • It did not ensure that products conformed to final specs, such as identity and strength of every active ingredient before they were released;
  • The company did not establish proper acceptance criteria for sampling/testing to make sure that all drug batches met appropriate specs and appropriate statistical QC criteria; and
  • It failed to produce proper written procedures for both production and process controls.

FDA cGMP Guideline Violations

During the cGMP inspection in 2012,m investigators also noticed that there was water all over the floor of the wash room for equipment. This water was then tracked into the room for equipment staging. It also was tracked into the corridor that led to the sterile production area, and also the area for vial filling.

May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement

Jubilant was required to explain how it will ensure that the CMO will not let water get into the aseptic filling room, the letter stated.

The CMO also did not do an investigation after a lot of a certain injection did not meet proper ph requirements. It also failed to give information on the root cause for such failures.

The warning letter from FDA noted that there also was a compressor failure that was caused by a power outage. This caused deviations in temperature that could cause an unacceptable appearance to thousands of vials of injections. Jubilant let most of the batch to be released, and FDA wanted an explanation for the decision.

Jubilant also needs to give updated data on all CAPAs that are related to any manufacturing operation and QC from March 2012.

As we reported this week, CMOs are coming under increased scrutiny for FDA cGMP warning letters and audits.

Upcoming FDA cGMP Webinars for 2013 include:

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