PROBLEM STATEMENT
Client 1: A large renowned consulting company needed a principal consultant to perform third-party review and batch certification for one of their global pharma clients, who was working on warning letter remediation for multiple sites.
Client 2: A large renowned consulting company needed a principal consultant to perform a third-party post-market drug review (Product Quality Assessment) for one of their pharma clients, who was working on warning letter remediation.
EXPERTISE AND SOLUTIONS
Client 1: The client company hired a principal consultant from PJI Biotech to conduct batch certification as a part of interim controls. All the protocols and checklists were developed to review raw materials, investigations, manufacturing and packaging records, analytical/micro data, facility/utility data, complaints, calibration/maintenance, cleaning, EM, and other applicable GMP records for batch certification. Once approved by clients, the batch certification was conducted for several months, while WL remediation was in process.
Client 2: The client company hired a principal consultant from PJI Biotech to conduct a Product Quality assessment for the Post-Market Drug Review to determine if batches are safe and comply with specifications and quality standards. All the protocols and checklists were reviewed to review batch records, test records, Annual product reviews (APR), regulatory filings, and historical quality data (complaints, field alerts, validations, change history, adverse events, etc.). The post-market drug product assessment was completed as per approved protocol and checklists.
RESULTS AND FEEDBACK
As a result, the Pharma company was able to release the product to market while FDA commitment remediation was in process (Client 1). As a result, the Pharma company was able to meet their FDA commitment objectives (Client 2). The client firm was pleased with the support provided, dedication, flexibility, and meeting their project objectives.
Please contact info@pjibiotech.com for PMDR and Batch Certification services.