General The manufacturer shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the manufacturer shall control and record the unique identification of the product. Note: Configuration management is a means by which identification and traceability can be maintained ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...

5. Clear policy on regulatory requirements, system and procedures is critical for efficient development and approval of new drug through generation of adequate non-clinical and clinical data and their evaluation in transparent and scientific manner for assessment of safety and effectiveness of the new drug. 6. Such policy will not only enhance the public assurance that any new drug approved for ma ...