Learn Technology Transfer from R & D to production and Technology Transfer Dossier and key aspects like process, packaging and cleaning.
What is Technology Transfer Dossier?
The Technology Transfer Dossier (TTD) is a crucial document provided by R&D to the product development laboratory. It encompasses key information related to formulation and drug product development. The following sections outline the vital components of the TTD.
- Master Formula Card (MFC):
- It provides information of Product such as product name, generic name, strength, MFC number, page number, effective date, shelf-life and market information.
- Master Packaging Card:
- It provides Packaging type, materials used, stability profile and packaging shelf-life details.
- Master Formula:
- Provide information about Formulation order and manufacturing instructions, providing insight into process order, environmental conditions, and dosage form development.
- Specifications and Standard Test Procedures (STPs):
- These provide information regarding the API and excipient profiles, in-process parameters, product release specifications, and finished product details.
Technology Transfer from R & D to production
Here are Considerations for Successful Technology Transfer from R & D to production.:
- Production Ability:
- Determine desired production approach: single-batch, continuous production, or campaigns.
- Consider level and depth of information transfer to facilitate production and additional process development at the receiving unit (RU).
- Technical Expertise and Site Capabilities:
- Assess RU’s technology and abilities.
- Recognize any process robustness issues and establish plans to address them.
- Develop a protocol for transferring crucial information from the sending unit (SU) to the RU, including process replication.
Process Transfer
- Safety, Health, and Environmental Information:
- SU provides details on manufacturing processes, including safety guidelines and protective clothing requirements.
- Processing and Testing Information:
- SU shares facility requirements, equipment details, and storage needs.
- Explains manufacturing steps, in-process hold times, raw material addition, and bulk transfers.
- Describes analytical methods, control strategies, and validation data.
- Provides manufacturing protocols and guidelines.
- Highlights specific facility or equipment requirements based on the product’s nature.
Process Development at the RU:
- Facility and Equipment Qualification:
- Compare and assess RU’s suitability and qualification for the process.
- Describe manufacturing procedures, personnel flow, and material handling at the RU.
- Identification of Key Manufacturing Phases:
- Determine critical hold times, endpoints, sampling points, and techniques.
- Standard Operating Procedures (SOPs):
- Develop and authorize SOPs for all production operations, cleaning, packaging, testing, and storage.
- Stability Information:
- Estimate stability data and obtain site-specific stability information.
- Regulatory Compliance:
- Ensure compliance with regulatory requirements when making changes to batch sizes.
Packaging Transfer
- SU provides specifications for containers, closures, and additional packaging requirements.
- RU conducts a suitability study for initial qualification of packaging components, focusing on protection, safety, compatibility and performance.
Cleaning Process
- Cleaning procedures and verification are site-specific.
- SU provides information on cleaning processes to reduce contamination risks.
- RU formulates its cleaning approach based on active ingredients, equipment design, residue removal and safety considerations.
The Technology Transfer Dossier (TTD) plays a pivotal role in successful product development and transfer. By effectively communicating critical information, addressing site-specific variations, and ensuring regulatory compliance, the RU can achieve consistent product quality and operational excellence.
Also read SUPAC guidelines.