Project Briefs

Pharmaceutical Industry: Preparation for Process Validation

Capability

Regulatory, Compliance & Quality
Technical Services

Client

A major generic pharmaceutical company

Problem

Following an FDA inspection that was critical of the client’s validation approach, a commitment was made to re-evaluate all marketed product validations and bring all validations of marketed products up to current industry standards.

Approach

Prior to executing the product revalidation, it was necessary to perform an assessment of validation readiness by a 3rd party expert, a comprehensive process parameter summary reflecting available data, an equipment validation gap analysis/remediation, and master batch record revisions. Tunnell assumed responsibility for the validation readiness component of this effort, as well as preparation of the process parameter summaries.

Tunnell senior formulation scientists reviewed regulatory submissions, development reports, validation data, and current production data for all currently manufactured products and produced for each product an independent assessment of the company’s readiness to validate. Reports identified gaps to be addressed prior to the revalidation effort.

A team of Tunnell pharmaceutical process engineers reviewed all available data covering product development, scale-up, validation, process improvement, and equipment qualification. The team reviewed the information with the client’s subject matter experts then published a final audited version of the summary. A binder containing copies of all supporting documentation was assembled to provide a ready reference for future product reviews or investigations.

Results

Outcomes of this effort included:

Assessments completed for 28 products
Process parameter summaries completed for 22 products
More than 950 documents and 32,000 pages of data reviewed
All reports delivered on schedule and within budget
Development and utilization of a standardized format for ease of review and remediation by client
Risks to successful validation identified and prioritized
Appropriate actions recommended to ensure successful revalidation

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Contact Info

Corporate Office
900 East Eighth Avenue
Suite 106
King of Prussia, PA 19406
Phone: 610.337.0820
Fax: 610.337.1884