Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ALLERGAN REVISING SOPs FOR IOL PROCESS VALIDATION

This article was originally published in The Gray Sheet

Executive Summary

ALLERGAN REVISING SOPs FOR IOL PROCESS VALIDATION at its Anasco, Puerto Rico manufacturing facility, the company says in a March 30 response to an FDA warning letter. In the warning letter, dated March 19, FDA takes issue with Allergan Medical Optics' Dec. 15 response to an FD-483 resulting from a November inspection. The agency maintains that the December letter's discussion of a citation regarding process validation did "not address the noted violation as observed by the investigator." Allergan states in the March 30 letter that it intends to review and revise the "current standard operating procedure that describes process validation" for intraocular lenses by April 16. As a part of the revision, the engineer responsible for the validation will be required to "review all manufacturing documents, including manufacturing instructions, inspection criteria and specifications affected by the validated changes," and include them in a validation file. The implementation of any changes are to "be made upon full review and sign-off of an Engineering Change Request (ECR) according to SOP." In addition, the ECR process will be modified to include a mandatory "training session of manufacturing personnel for any validated process, material or specification changes." The training will be documented in both the ECR file and the employee training record, Allergan says. The warning letter also questions the company's answer to a violation cited in the FD-483 regarding the accessibility of records at the manufacturing site. FDA states: "The response does not accurately characterize the difficulties experienced by the investigator in obtaining copies of records required to be 'reasonably accessible'" in GMP regs. However, FDA adds that a proposed Allergan document imaging project, which would allow electronic access to records not maintained on site, "appears to adequately address record accessibility, as long as the system works." Allergan says that the "difficulties" encountered by FDA were attributable to the company's retention of "certain records" at its headquarters in Irvine, California, rather than on-site in Anasco. While the company contends that "this practice is permissible" under FDA regulations, it intends to make several "improvements" so that records maintained at the Irvine facility are available "to FDA inspectors of the Anasco facility." For example, current device master records and complaint files presently maintained at the manufacturing site in Anasco are to be "available immediately for inspection by an appropriate FDA official," while DMRs and device history records currently maintained in Irvine are to be made available to FDA "within 24 hours of a request" for inspection. The delay, the company maintains, "is fully justified, given the logistics of sending such documents" from California to Puerto Rico. In the instances where the 24 hour deadline cannot be met, the company intends to "work in close cooperation with the field inspector to achieve an expedited and mutually acceptable timetable for production of such documents." Allergan also says that it intends to create a "computerized document management system in the Anasco facility which will allow immediate electronic access" to records stored at Irvine. The system, which is to be "validated prior to implementation in accordance with a validation protocol," is to include "all DHRs and DMRs from 1993 onward." Earlier documents will continue to be maintained in a manual system.

You may also be interested in...



Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs

Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.

Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats

The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.

Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States

Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT000457

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel