d. Technology transfer from R&D to production: It involves the transfer of technology
from the R&D department to production. A technology transfer dossier
(containing all information about the product, process or method ) is provided
by the R&D department to product development lab (Fig. 4.3 and Table 4.1).
Fig. 4.2: Stages of technology transfer process
Technology Development and Transfer 53
Fig. 4.3: Contents of technology transfer dossier
Table 4.1: Documents to be prepared during the TT process while preparing technology transfer
1. Master formula card It contains product name with strength, generic name,
manufacturing formula number, date, shelf life, packaging
and marketing details with artwork
Ingredient details: Brand name, specifications, vendor label
claim, manufacturing detail in brief
2. Master formula It contains manufacturing instructions and formulation
3. Standard test procedures It gives details about qualitative and quantitative parameters
and specifications of active ingredients, excipients and finished products.
Standard test procedure explains the method of conducting
quality tests and specifications specify the limits.
4. Master packaging card It involves the following details about packaging
Packaging type, the material used for packaging, packaging
material stability testing report, the shelf life of packaging
5. Development report It is composed of all the documentation generated during
the formulation and process development phase of product
(drug/process/method). There are following six critical
sections in product development reports:
Component of product, manufacturing process
development, The rationale for choosing the container/
closure system, The rationale for selecting a preservative
system, microbial limits and antimicrobial effective tests,
Compatibility of the product with diluents or dilution prior
to administration for labelling information.
All information about product formulation development,
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