1.

Objective: To lay down a procedure for changeover of one product to another and one
batch to another.

2. Responsibility: Concerned operators/production supervisor.

3. Accountability: Production Pharmacist

4. Procedure:
a. CHANGE OVER OF THE SAME PRODUCT:
i. This deals with the change over procedure from batch to batch of the same
product.

ii. During this type of change over the entire machine, change parts,
equipments and floor should be washed with 1 % v/v of liquid soap or
surfactant solution.

iii. This washing should be rinsed with tap water and followed by rinsing with
DM water for machine, equipments and other parts that are in direct
contact with the product.

iv. The cleaning certificate should then be filled with indication of the SOP
no by the production supervisor and remarks of observation by the IPQC
supervisor. The test report is issued upon the visual inspection by the
IPQC Supervisor.

v. The cleaning certificate is then signed by authorized production officers

and authorized QA/QC officers.

b. CHANGE OVER FOR DIFFERENT PRODUCT

i. This deals with the change over procedure between batches of the
different product.

ii. During this type of change over the entire machine, change parts,
equipments and floor including walls, doors and windows should be
washed with 1 % v/v of liquid soap or surfactant solution

iii. This washing should be rinsed with tap water and followed by rinsing with
DM water especially for machine, equipments and other parts that are in
direct contact with the product.
iv. The rinse sample is collected and analyzed for residue of surfactants and
product remnants.

v. The cleaning certificate is then issued only after approval from the QA on
the basis of test report.

vi. The test reference is included in the cleaning certificate & the report
attached to the batch documents along with the cleaning certificates.

vii. The cleaning certificate is then signed by the Production Officer and
QA/QC Officer.