QBD-Quality by Design

QBD-  A to Z  

A-Avoid Mix Up-Try not to mix two or more products with different specification into each other

B-Beware of labelling Error-Product of different categories and different batches should be properly labelled and should be error free.

C-Change in documents, process, procedures, method, equipment and facility must be captured & Controlled

D-Document all activity which will control /effect the product quality and also other activities which belong to process should also be recorded.

E-Ensure that Equipment/instruments are cleaned before use.

F-Follow the instruction Exactly as Written or mentioned in controlled documents like Standard Operating procedure.

G-Good personnel hygiene & Sanitization must be maintained.

H-Handle Carefully Hazard Waste Like waste from Micro biology lab, waste from

manufacturing, Effluent treatment Waste.

I-Identify Items/Products with proper labelling (Status Labelling).

J-Just follow the authorized written documents.

K-Keep the facility Area, System and equipment in clean & good condition.

L-Line Clearance must be taken before starting of any stage from dispensing, manufacturing & packing, production activities.

M-Maintain your area, system, Equipment, Instrument & process in calibrated / Validated state.

N-Never Lie, Cheat or steel, always strike a fair deal.

O-Open your eyes and see things as they really are.

P-Practice make the things perfect.

Q-Quality Does not come as an accident, it should be built in our product by practicing GMP.

R-Read, Study, Learn and implementation of system processes.

S-SOP’s (Standard Operating procedures) must be followed every time, all the time.

T-Training must be imparted to all employees.

U-Unauthorized entry to restricted area is strictly prohibited.

V-Validate your area, System, process, Equipment, Instrument, personal before entering.

W-Write what you do, do what you write, prove it, improve it.

X-Xerox copy not to be used –Use only controlled & Issued copies.

Y-Yes I Will follow.

Z-Zero Defects in product is our moto…