Tài liệu formulation management ppt

Process owner: Development departments Process purpose and target: Creation and maintenance of production prescriptions inclusive all necessary specifications Schnittstellen Laboratory

Process owner: Development departments

Process purpose and

target:

Creation and maintenance of production prescriptions inclusive all necessary specifications

Schnittstellen

Laboratory journal

product specifications, raw material selection

R05-Production Batch

formulation

Process parameter, corrections

R 02-Auftragsabwicklung Item stock article specifications

(PPS)

Prescription

monitoring/characteristic numbers quality

input prescriptions (samples) Environment:

- Prescription : a 8-digit number indicates and contains all production-relevant data

as well as the technical specifications

- Articles: a 12-digit number indicates and contains apart from a reference to the

prescription specification to the bundle and all sales relevant designations

EAN articles indicate a number with 13 digits

Flow/process documentation/competence

First draft of formulation and

article creation

Responsibility Documents

Check of formulation

Color correction

Raw material correction

Formulation database Article database

AS : IT Rest : Development

see R 05

AS : IT (Sales) Rest : Indoor sales

RS : Production (Development)

RS : Production

OT : Development

PS : Development

TX : Production, Development

All : Development

RS : Raw material

OT : OT-Info

PS : Test requirements

TX : Text

AS : Article database

Maintainance of

(Sales, Dev., Prod.)

Remarks for production and approval

OT : Development

TX : Production

R04

S 11

Formulation Article data R02

R05

competence range of a prescription:

A prescription consists of the following sections:

- product number (no subsequent modification possible)

- version number (in the PPS one updates automatically)

- product description (OT): This contains the basic description the product and is summarized in the EDV form " OT info "

- the prescription constituents (R-S) (raw material code and quantity) and if

necessary process descriptions within the raw material area of the EDV form

- test predeterminations (HP): These contain all checks the inclusive pre-set values for the internal check of the product The list takes place in the EDV form " test debit specifications

- additional text (TX): In this text field all further information, those necessarily for a product are summarized

- EDV contractions and date of the last modification - item stock (AS) with date and EDV contraction of the last modification The item stock contains the sales relevant data for all sales products

Current prescription maintenance:

Due to newer realizations or production or raw material-conditioned shifts the

prescription must be constantly adapted

These modifications are evidently, comprehensible within the remaining areas by fixing the date and the contraction in the raw material area by an increase of the version number Applicable documents - EDV documentation

Applicable documents

EDV documentation