GMP – Good Manufacturing Practice
Netstal GMP Documentation
The guidelines serving to assure Quality Assurance plays a central role
the quality of the production in the production of pharmaceuticals
sequences and the environment because quality deviations in this
in the production of pharma area can have direct effects on the
ceuticals and active substances health of the users.
are summarized under the term
of GMP (Good Manufacturing A Quality Management System
Practice). s atisfying GMP principles serves to
guarantee the product quality
and the compliance with the binding
marketing specifications of the The production of medical moulding
health authorities. imposes high demands on
man and machine
Suitable guidelines have been
established by e.g. the European onference on Harmonisation of
C
Authority for Pharmaceuticals EMEA, Technical Requirements for the
the US-American FDA and at a Registration of Pharmaceuticals for
global level the International Human Use (ICH).
Netstal’s GMP Documentation in the context of the different
requirements and fundamentals:
Laws Specifications
GMP Guideline FDA
on medicine for clean rooms
Netstal GMP Documentation
Customer-specific part of the operating instructions
Standard operating instructions
Netstal Management System
EN ISO 9001:2000
SWISS MADE
GMP – Good Manufacturing Practice
GMP – Good Manufacturing Practice
Netstal GMP Documentation
Contents of the standard operating instructions
CE Declaration of Conformity List of electrical spare parts
Operations, displays, operating modes Electric diagrams incl. parts lists
Transport, installation, commissioning, operation Energy, connections and cross-sections
Setting-up tasks Pneumatics
Operating surface Hydraulics
Functions and parameterization Cleaning instructions
Foundation plan Safety instructions
Production drawings and parts lists Maintenance schedule of the machine
Consumables required / specifications nC operating instructions
t
Additional contents of Netstal’s GMP Documentation
General / special references to the software List of the modifications and supplements
version and release of the firmware concerning objects which have been altered
Various risk analyses in relation to the standard The possibility of having a
and customer-specific equipment of the machine FAT (Factory Acceptance Test) and a
Manual on the Quality Management SAT (Site Acceptance Test) carried out
of Netstal-Maschinen AG Availability of training courses
A special calibration of the machine for the machines concerned
if appropriate Customer-specific documents
Various checklists and commissioning protocols
of the machine and subassemblies
Specifications and system requirements
What demands are imposed on a production
Advantages of Netstal’s GMP Documentation
in conformity with GMP?
Planning with risk analysis (FMEA)
Machine /system incl. complete documentation
Internal sequences must be documented and traceable
comes out of one hand
Working steps must be documented
Documentation and calibration* in conformity with GMP
Amendments / modifications must be documented
Coordinated with the standard machine documentation
Personnel must be trained
The documentation has been validated
Documents must be collected / summarized
by a reputable institution
and accessible at any time in a central location
Years of experience from numerous customer
projects are at the basis
Calibration contracts over the machine’s full life
in conformity with FDA
* Sales option
How are the responsibilities split between Netstal and the customer?
URS User Requirements Specification
Release
Systemanrequirements
Kunden nednuK na
Specifications /quotation PQ Performance Qualification
Planning of machine design (1st stage)
OQ Operation Qualification
Detailed description of the functions
Planning of machine design (2nd stage)
IQ Installation Qualification with
Preparation of the documents (R&I, E / MSR)
SAT Site Acceptance Test
DQ Design Qualification
Assembly Erection at the customer’s
Qualification at the works (IQ Installation Qualification,
OQ Operation Qualification, PQ Performance Qualification)
Factory Acceptance Test
Transfer
Netstal’s responsibility The customer’s responsibility
DQ Design Qualification IQ Installation Qualification OQ Operation Qualification PQ Performance Qualification
( draft qualification) ( system qualification) Proof that infrastructure Proof of the system’s performance
Proof that the requirements of Proof that infrastructure and and production equipment work in routine operation.
specifications and master valida- production equipment have been in accordance with their
tion plan have been translated built and installed in accordance specifications.
in the design of the system. with their specifications.
GMP – Good Manufacturing Practice
Contents of a Netstal GMP Documentation
Document designation Description of the document
“General references to the software GMP” General references where software is filed and what can be looked up where
Where do I see the software version of the machine / of the system?
“Release of the firmware for Netstal SynErgy Release document of the standard software version for GMP machines
plastic injection moulding machines for use
in operations with GMP processes”
Work instruction for filing of the backup Describes where the backup of the
in the machine software of the specific machine is filed
Description of the alarms and Describes the alarm concept of the special software
interlocks list special software and where the descriptions are filed
Calibration protocol (option) Calibration of all measuring systems of the machine of relevance to the quality,
with external, calibrated inspection devices – in conformity with FDA
• NM standard
• According to list of options
• Additional customer-specific inspection authorities
Commissioning / reception protocol part B – List of all key parts with the serial numbers
Technical data
Commissioning / reception protocol part A – Checklist for the Netstal-internal reception
Checklist for the complete system
Checklists for subassemblies Checklists for all individual subassemblies
Certificate for high voltage, earth conductor Certificate for high voltage, earth conductor and insulation measurements
and insulation measurements according to
EN 60204-1 / IEC 204-1 / DIN VDE 0113
SN EN ISO 9001: 2000 certificate Proof of the Netstal Q-system being certified
Netstal Management Manual Description of Netstal’s Management System, of the quality, safety and environment policy
The Netstal Quality Plan
User Requirements Specification (URS) – Describes the scope of supply demanded from Netstal
4User requirements 4To be provided by the customer!
Order acknowledgement Specifications to be met by Netstal
Risk analysis for standard machines Risk analysis (FMEA) for the standard machine with the equipment variants
Risk analysis for special adaptations Risk analysis (FMEA) for the special adaptations –
it shows the influence of special adaptations on the standard execution
Work instruction for the application Work instruction for the application of certificates
of certificates of “components of relevance of “components of relevance to safety” on the machine
to safety” on the machine
Certificate for the materials List of all parts of the plasticizing unit and certificate of harmlessness
used for parts of the plasticizing unit
Change Control List of all amendments after issue of the Order Acknowledgment
Training courses Overview of the training courses on the Netstal model ranges in question
FAT Factory Acceptance Test – detailed inspection of all specified items,
whether or not the completely assembled machine complies with the specifications
Various levels of FAT:
• Machine only without function test – purely visual inspection
• Machine only with function test
• Machine incl. periphery (mould, handling system),
incl. function test and production of moulded articles
4To be specified by the customer at the time of ordering
SAT Site Acceptance Test – comprehensive testing of the complete system
under production conditions
4Is the customer’s responsibility unless agreed otherwise
Netstal-Maschinen AG
8752 Näfels / Switzerland
Phone +41 55 618 6111
Fax +41 55 618 66 05
Internet www.netstal.com
SWISS MADE E-mail marketing @netstal.com
