Sun Pharmaceuticals Industries Ltd..

Sun Pharmaceuticals Industries Ltd..
Product: pharmaceutical manufacturing facilities
Date: 12/17/2015

Our investigators observed specific violations during the inspection, including, but not limited to the following.
6. Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel (21 CFR 211. 68(b)).

You lacked audit trails or other sufficient controls to facilitate traceability of the individuals who access each of the programmable logic controller (PLC) levels or Man-Machine Interface (MMI) equipment. You had no way to verify that individuals have not changed, adjusted, or modified equipment operation parameters.

Access to production equipment used in parenteral manufacturing and solid (b)(4) dosage forms used a password shared by four or five individuals to gain access to each individual piece of equipment and access level. During our inspection, your Executive Production and QA manager confirmed that the password was shared. Neither your operators nor your supervisors had individual passwords.

During our inspection, firm officials also confirmed that you had not established or documented a control program to describe the roles and responsibilities of production equipment system administrators. There was also no record documenting the individuals who have access to the production equipment or the manner in which individual personnel access production equipment.

In your response, you indicated that you have performed a comprehensive review of the PLCs and manufacturing equipment associated with the production of parenteral and solid (b)(4) dosage forms to assess your access controls and traceability to individual operators. You suggested that traceability to the individual operator could be determined through a hybrid system using the batch manufacturing record and equipment logbook. However, because you used shared login credentials that did not permit identification of a specific person using the shared login, you have not shown how your hybrid system could link specific actions to a specific operator.

In your response, you also stated that you will conduct a retrospective risk assessment to evaluate the effects of your deficient computerized system controls on the quality of the products manufactured using this automated equipment. However, you did not indicated the timeframe for your review, your criteria for evaluating the effects of these deficiencies on your products, or any actions needed for products within expiry.

Finally, in your response, you indicated that you planned to (b)(4). Your response is inadequate because you did not indicate what controls you will implement in the interim to assure that only authorized personnel change your production or other records.

In response to the letter, provide your retrospective review and risk assessment of lots manufactured using equipment with shared passwords. Explain how you will identify which operators or personnel performed and recorded specific activities, your criteria for evaluating how manufacturing and quality of your products has been affected by your deficient controls, and any actions needed to assure the quality, safety, and efficacy of products within expirry.

FDA District Office: CDRH

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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