Polypharma Technology Transfer for pharma production

Polypharma Technologies & Sciences supports generic medicine manufacturers in Middle East and North Africa (MENA) markets to reach full scale production and marketing approval with its comprehensive Technology Transfer and Registration service.

The service covers all aspects of pharmaceutical tech transfer from proving and pilot batches into final generic drug production, following best practice guidelines defined by the International Society of Pharmaceutical Engineers (ISPE).

Overcoming production challenges

Drug producers in MENA markets can experience severe problems in all aspects of the manufacturing process, particularly in the complexities of scaling up to industrial and commercial scale and accompanying regulatory validation of process and products. The Polypharma tech transfer service opens the way for every stage of the process to be smoothly implemented with quality issues addressed in partnership.

The Polypharma Technology Transfer and Registration Service covers the later stages of the journey from source active ingredient to production of a fully registered medicine, including scale-up from small batch quantities to commercial scale manufacturing.

The service provides local support in technology transfer, once partners reach the point of manufacturing validation lots for the registration process.

Polypharma’s technical teams work hand in hand with the client’s production and analytical teams to sort out all manufacturing process stages, including weighing and preparation of raw materials, production, filling and primary packaging and final loading into secondary packaging ready for market.

Comprehensive tech transfer solutions

The service encompasses regulatory requirements for various types of technology transfer, including analysis of manufacturing process, its validation and verification, storage inspection, quality control (QC) testing, and environmental impact checking.

By implementing the first production jointly, Polypharma can carry out in-process troubleshooting with the production team in advance of formal inspection so that the production of the generic product can be implemented smoothly.

The Polypharma technical experts can also support client production team with a complete analytical approach of the active substance and the finished drug, analytical methods and specifications, to ensure compliant provision of all relevant documentation for product registration.

Tech transfer pharma benefits

For the partner generic drug producer, the Polypharma Technology Transfer and Registration Service delivers powerful benefits for pharmaceutical production and regulatory compliance, including:

• Close support for the manufacturing process
• Retained control over the manufacturing process by working in close partnership
• Ability to conduct more effective product planning
• Technology transfer ISPE good practice guidelines compliance to ensure product quality and faster regulatory approval
• Fast and smooth registration of drugs, reducing time to market.

Resources

Click on Polypharma Technology transfer and registration service for more information.