| Detail
Rules and Regulation |
| Content |
Participant |
Input time |
Method
|
Results |
| * Phase-in stage |
|
|
|
|
| 1. Communication and
understanding / form a task force team |
Management rep. |
|
Discussion individually
|
|
| 2. Interpret regulations
item by item |
Department Head |
|
Education and
training
|
|
| * Planning stage |
|
|
|
|
| 1. Organization |
Management rep. |
|
|
|
| 2. Plan desired documents |
Management rep. |
|
Discussion individually
|
|
| 3. Arrange daily schedule |
Management rep. |
|
Discussion individually
|
|
| 4. Setting documentation
rules and guideline |
Department Head |
|
Discussion individually
|
|
| * Deploy Stages |
|
|
|
|
| 1. Setting goal |
Management rep. |
|
Education and
training
|
|
| 2. Training for various
documentation |
All employee |
|
Education and
training
|
|
| 3. to set up / review
/ modify S.O.P. of GMP |
Related personnel |
|
Education and
training
|
|
| ---
Manufacturing Dept. |
|
|
Discussion individually
|
Completed related
S.O.P. |
| ---- Material management
Dept. |
|
|
|
Completed related
S.O.P. |
| --- Quality assure
Dept. |
|
|
|
Completed related
S.O.P. |
| 4. To set up / review
/ modify S.I.P. for manufacturing |
Related personnel |
|
Education and
training
|
|
| --- S.P.F. |
|
|
Discussion individually
|
Completed S.P.F. of
product |
| --- S.O.I. |
|
|
|
S.O.P. & Monograph |
| --- Inspection standard
for the raw material. Semi-products and finished good |
|
|
|
|
| --- Manufacturing
batch record |
|
|
|
Completed batch record |
| 5. To set up / review
/ modify for operation area identification & voucher |
Related personnel |
|
Discussion individually
|
Completed batch record |
| 6. To set up /review/modification
S.O.P. for water |
Related personnel |
|
Education and
training
|
|
| --Master Plan |
|
|
Discussion individually
|
Completed batch record |
| --IQ、OQ & PQ |
|
|
|
IQ, OQ,
PQ & SOP |
| --SOP |
|
|
|
| --Calibration Program |
|
|
|
|
| 7. To set up SOP for
air-conditioning system / review / amend |
Related personnel |
|
Education and
training
|
|
| --Master Plan |
|
|
Discussion individually
|
Competed
master plan |
| --- IQ, OQ & PQ |
|
|
|
IQ, OQ,
PQ & SOP |
| --- S.O.P. |
|
|
|
| --- Calibration program |
|
|
|
|
| * Implementation stage |
|
|
|
|
| 1. To release / implement
all related document / rules |
Related personnel |
|
Discussion individually
|
Completed all documents |
| * Auditing stage |
|
|
|
|
| 1. Education / training
of internal auditing |
Auditing team |
|
Education and
training
|
|
| 2. Executing internal
auditing |
Auditing team |
|
Education and
training
|
|
| 3. Weakness corrective
action |
Auditing team |
|
Education and
training
|
|
| 4. Management review
board |
Management rep. |
|
Discussion individually
|
|
| * Verification stage |
|
|
|
|
| 1. Simulation |
|
|
Auditing individually
|
|
| 2. Weakness corrective
action |
|
|
Education and
discussion
|
|
| 3. Factory verification
pass |
|
|
|
Approved by CGMP |
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