The PQRI (Product Quality Research Institute), MTC (Manufacturing Technology

Committee) has produced several working tools to increase or boost up consistency in

use of ICH Q9. The description of the tools is given in Table 5.2.

Table 5.1: Type of integration of QRM and areas of benefit

Sr. No. Type of integration Facilitation of Areas of benefit

1. QRM integration with key “What to do?” Integrated quality management.

quality system elements Facilities, equipment and utilities.

Supplies, material and contract

service management.

Technology transfer.

2. QRM integration with product “How to do?” Production

manufacturing operation Laboratory control and stability

studies

Packaging and labelling

Storage, transport and distribution

74 Industrial Pharmacy II

5.8 TRANSFER FROM R&D TO PRODUCTION (PROCESS, PACKAGING AND

CLEANING) AND GRANULARITY OF TT PROCESS (API, EXCIPIENTS,

FINISHED PRODUCTS, PACKAGING MATERIAL)

The transfer process is one of the most critical steps in technology transfer. Certain

things that should be ensured by sending unit are as follows:

i. The RU should accommodate the intended production capacity. If possible, the

production capacity should be established (in keeping the view that the production

is in single-batch, or continuous or campaigns) at the beginning of the process.

ii. Consideration should be given to the level and depth of the detail which is to be

transferred to RU. The detail can be to support production or any further process

development or for optimisation at RU as intended in the transfer project plan.

Table 5.2: Tools of QRM

Sr. No Tools Description Application

1. Flowchart, check Simple techniques, use to Compilation of observations.

sheets, etc. gather and organise the data, Sorting out data