US FDA Observations at Dr. Reddy's Srikakulam API Plant

USFDA observations at Dr. Reddy’s Srikakulam API plant

Update 2015 May 28: Click here to see the orignal form 483 issued to Dr Reddy's

Observation 1

Lab records don't include complete data derived from all tests. The inspectors indicate five instances where all the test failures were not documented and reported as per standard operating procedure (SOP). The reported results don’t contain the earlier sample analysis.

Observation 2

The inspection highlights unauthorised access to computer system. An instance was noted where data was deleted by an unauthorised person.

Observation 3

The Batch production and control records didn’t have the entries filled after each and every step as required by SOP. The data were filled simultaneously.

Observation 4

Procedures regarding the issuance, revision, superseding and withdrawal of documents not followed.

Observation 5

Water used in the manufacture of APIs is not established to be suitable for use. The microbiological test methods were not verified and validated.

Observation 6

Record of training of operators not maintained properly.

Observation 7

Failure to justify and follow up on deviations or batch failures: The inspectors made two observations where a batch has failed on certain parameters. Either the investigations are incomplete or the conclusion was not satisfactory.

Observation 8

Process validations: The inspectors raised questions on the process validation approach that would ensure that the process can be performed effectively and reproduce the desired results. The inspectors highlight a case of significant numbers of reprocessing carried out by the company, raising questions on the process.

Observation 9

Adequate and clean washing and toilet facilities are not provided for personnel. The inspectors highlight that toilet facilities are located at a long distance.

Source: Nomura

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : multi eye-2 by Ben Mortimer is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

BLOG

MARKET INTEL by PharmaCompass

CONTENT by Suppliers

News