Readiness building for GMP and QA inspections: Intro

Into the details

Data and records

Make them available• Do not fret when

asked for data: that’s their way to be “Scientific”

• They may want to see measurement data, e.g., pressure control record for a particular room

• Labeling and marking must be recorded, on a logbook or via LIMS or any other means

• Never say “we have it but can’t show you”: they are not industrial spies

• They will ask record and data for MANY MANY MANY and MANY things: never show you’re fed up

• Protocols and procedures kept in each plant/room/lab must be available during the inspection

Process

Seeing is believing…• Inspecting is

seeing: they may ask you to:• Show where the

water is sampled and how often

• Show where the solvents are stored

• Show where the temperature sensors are placed in the warehouse

• They may check the calibration stickers on several scales

• They may want to see how HPLC columns are managed and have a look on logbooks

• They are likely to ask you to show where the raticides or anti-vermin are placed

Analyses

Talking about validation• They may ask you to

present analytical data obtained during validation.

• The method of analysis must be sound and well-established.

• This includes statistical methods, lab methods, you name it…

• Don’t be afraid to show bad results obtained at one time point: show it, then show other documents demonstrating that the problem was addressed for good and all

• Negative data may also be seen as valuable

H & E

Not just another formality• State that the site is

exerting a great deal of efforts to address environmental issues

• Say hygiene and staff’s well-being are points that are definitely cared for

• Show that fire control is nothing new to you

• Check the overall cleanliness of the site before inspection

• There might be questions on security that seem so basic and obvious: don’t try to pass over it, give thorough answers to the point they will stop you and say “OK!”

Info provided

A runner is a must, two runners are better

• During the document inspection session, be prepared to go fetch many documents, records or logs.

• All documents requested by the inspectors should be brought on the table ASAP. They love things going smoothly

• Even if the background of a chemical reaction used in the process is textbook-level and matter-of-fact, they may ask you if you tested it

• They will ask you data, data and data. As futile as could be, it’s OK if done

Don’t

The “Don’ts”• Win a discussion.

Culturally, Japanese seldom say ”no”.

• Even if you don’t agree, say “OK, I see”: you may see it but think differently

• Don’t show you are not content. Don’t argue

• Refuse a request straight away: stall a bit, tell that you have to confer with someone prior to, then, later, tell them it is going to be difficult (give whatever reason that seems sound)

• Don’t be afraid, they are human after all

Human beings are mainly composed of …

LadiesGentlemenPMDA inspectors

…But they are not from Mars or some unknown planet.

Discuss with the interpreters if there is any doubt.

Not just dictionaries on foot,They are here to do the

interfacing between two very different cultures, a hard job

I ♥ QA

QA is an institution in Japan

• Tell them how concerned you are with QA issues*

• Tell them how wonderful the site has become after implementation of such and such QA measures*

• Tell them everybody working in this site is aware of the importance of QA*

* Even if it is not 100% true.

World apart

But could get closer• EUROPE

• Long history

• Rich cultural background

• Economically advanced

• Politically stable

Implements GMP!

• JAPAN• Long history

• Rich cultural background

• Economically advanced

• Politically stable

Implements GMP!

Too complicated ?!?

No contamination allowed

Exactitude

Routine

Checking

Updating

Maintenance

Stick to the books

The 3 “S”

Keypersons

Attention!

Let’s stay Zen.

Have you seen the light?