BTS (Business Technology Solution), achieved a first in Turkey and based on its experience of many years, started to offer Product Transfer Services to pharmaceutical companies.
Throughout the transfer of pharmaceutical products from one production site to another, there are regulatory obligations determined by Ministry of Health with which pharmaceutical companies must comply. BTS successfully manages actions that are required by these requlatory obligations comprehensively, correctly and within the determined time frame.
BTS (Business Technology Solution), achieved a first in Turkey and based on its experience of many years, started to provide services to pharmaceutical companies in a new field. BTS manages the GMP (Good Manufacturing Practices) actions for product transfers between manufacturing sites required by regulatory procedures. In this way companies can complete product transfer in time and comprehensively and correctly complying with regulatory procedures. Depending on the number of products, the product transfer management projects take 6 months to 1 year.
BTS also offers GMP audit services for the new production site to those companies seeking to localize abroad production or change their existing production site within the country.
BTS Product Transfer Management service prevents workforce loss.
Regarding Product Transfer Management service, BTS Business Development Executive Figen Ergin expresses that when pharmaceutical companies attempt to realize product transfer projects with their own personnel, delays in project deadlines are experienced due to existing workloads. Ergin; Ürün Transferi Yönetimi konusunda uzmanlığa sahip olan BTS’den hizmet alındığı zaman, firmaların mevcut iş güçleriyle rutin işlerine odaklanabildiklerini ve Ürün Transferi projelerini belirlenen zaman planlarına uygun ve gerekli tüm aksiyonlar tam anlamıyla alınmış olarak tamamlanmasını garanti edebileceklerini belirtiyor. Ergin states that when companies employ BTS services, reinforced with its specialization in Product Transfer Management, they can focus on their core business and they can guarantee to complete Product Transfer projects within the determined time frame and exclusively fulfilling all required actions.
For companies wishing to reduce costs, as an additional service, BTS also offers cost saving projects resulting from detailed investigations within Product Transfer Management.
Product Transfer Management Methodology
Product transfer is assessed against ICH Q9 Risk Management requirements and required actions are determined. QMex electronic action tracking module ensures that required documentation is completed for the whole transfer to be in compliance with Ministry of Health regulations and GMP requirements.
Project is divided into several phases:
- Phase; Regulatory compliance check is completed for each produvt to be transferred. For this purpose production documentation is compared against the documents presented to the Ministry. If there are discrepancies at various levels these are eliminated by submitting corrective documentation to the Ministry of Health.
- Phase; Analytical Method Transfers, Analysis Method revisions, Specification revisions, Poduction Method revisions, Printed Material revisions, Product Technical Drawings, Process Validation Protocols, Stability Protocols, punch drawings to be used in production are completed.
Products are prioritized according to sales plans and existing inventory.
- Phase; Transfer productions and process validation reports are completed, stability studies are initiated and Marketing Access registrations are made, Ministry of Health approval is obtained and routine production is launched.