1.2.3 Pilot-Plant Operations

A pilot-plant operation includes series of operational aspects. These are as follows:

1. Validation includes the following of all utility systems, process equipments, control

systems so that pilot-plant can be fully validated and ensure compliance with CGMP

i. DQ (Design Qualification)

ii. IQ (Installation Qualification)

iii. OQ (Operational Qualification)

iv. PQ (Performance Qualification)

2. Training should be given in four areas

i. Compliance with CGMP and other quality systems

ii. Environmental and safety responsibilities

iii. Compliance with SOPs

iv. Technical knowledge and skills

3. Engineering support is required for

i. Design, commissioning, and validation of pilot-plant facility

ii. Co-ordination, direction and scheduling of ongoing operations at the pilotplant facility

4. Maintenance is required

i. To compliance with CGMP norms

ii. To ensure integrity of data and reliability of equipment

5. Calibration of equipment/instrument is required

i. To compliance with CGMP norms

ii. To ensure the integrity of data generated during the development process

6. Material control with computer-based system

7. Inventory should be maintained by computer-based inventory system

8. Orders should be placed through computer-based system and first-in first-out

criteria is followed.

9. Labelling should be done in compliance with regulatory guidelines

10. Process and manufacturing activities includes

i. Formulation and process development

ii. Clinical supply manufacture

iii. Technology evaluation, scale and transfer

11. QA and QC activities

QA activity involves

i. Auditing pilot-plant, component suppliers.

ii. Reviewing validation and engineering documentation

iii. Reviewing, approving and maintaining batch records for clinical supplies

iv. Sampling and release of raw materials and clinical supplies

v. Maintaining and approval of SOPs

Introduction to Pilot-Plant and Scale-up 5

QC activities include

i. Releasing and testing (physical, chemical and microbiological testing) of

finished products.

ii. Testing for validation as well as revalidation programs.

iii. QC in-process testing during each stage (drug development, pilot-plant, scaleup and technology transfer)