Inspection Monitor , 12/01/1998 3 12
Out-of-spec results cast doubt on API validation.(active pharmaceutical ingredient validation, Rhone-Poulenc Rorer Inc.)(Brief Article)
COPYRIGHT 1998 Washington Information Source
Rhone-Poulenc Rorer, Holmes Chapel, UK. Two of FDA's favorite themes B validation and out-of-specification results B elicited a brief 483 to Rhone-Poulenc Rorer>s aerosol and active pharmaceutical ingredient (API) plant in Holmes Chapel, UK.
Investigator Eric Weilage of the Atlanta District Office and microbiologist Ronald Crawford of FDA's Southwest Research Lab considered a series of rejected batches of Tilade (nedocromil sodium 2 mg) inhalers an indication that the system was not validated. The batches were rejected due to Ahigh out-of-specification@ test results, according to the EIR.
The recently released records from the April 1997 audit said the out- of-spec results in-volved medication delivery and dose uniformity.
The company had conducted an Aextensive@ but unsuccessful investigation to identify the cause of the out-of-spec results. Management promised to conduct further investigation, ac-cording to the EIR.
The firm fared better in the other areas covered in the audit. Among these were the API manufacturing equipment and facilities, new equipment and related validation, complaints, cleaning validation and failure investigation reports, plus microbiology lab equipment, procedures and test results. The most recent process validation showed no significant deficiencies, the EIR said.
An investigation into problems with a different product, whose identity was purged from the records, had led to a recall in 1996. But, in that case, FDA termed the company's investigation not only Aextensive@ but Aadequate,@ according to the EIR. A quality improvement program resulted from the firm's findings, the report added.
A new chemical operations building was not covered during the inspection, since it was still under construction and its validation was not complete.
As of deadline, it could not be determined whether the company was able to track down the cause of the Tilade rejects or whether the compa-ny was able to close the issue with FDA.
Rhone-Poulenc Rorer, Holmes Chapel, UK, 4/1-4/97, Doc. 108526M, $4.50 plus retrieval.
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2 comments:
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