Professional Documents
Culture Documents
INTRODUCTION:
ISO is the worlds largest developer of voluntary standards. ISOS
core activity is the development of voluntary standards but its scope is
expanding in the areas of services, management practices and conformity
assessment. ISO standards therefore have a growing economic and social
impact.
The ISO is responsible for developing, maintaining and publishing
the ISO family. ISO is a non government organization network of the
national standards institutes of 150 countries with one member per country
with a central secretariat in Geneva, Switzerland co-ordinates the system. It
was created in 1947.
DEFINITION:
ISO is the fundamental generic element that would form the basis for
a series of internationally recognized quality management standards.
ISO 9000series is a set of internationally quality system standards for
a) Designing.
b) Manufacturing.
c) Servicing the product your company produces.
This quality system was audited by the third party with the resulting
being published. The third party audit of the quality system should be
b)
c)
2.
3.
ISO is for export: The driving force behind ISO 9000 accreditation is
What it contains
System
ISO 9000
Quality management
Q.A. standards.
ISO 9001
Quality systems.
&
ISO 9002
Quality systems
ISO 9003
Quality systems
ISO 9004
ISO
9000-1
Guidelines for selection & use. (Provide guidance on which std to use)
ISO
9000-2
Guidelines for the application of ISO 9001, ISO 9002, ISO 9003.
ISO
9000-3
Guidelines for the application of ISO 9001 to the development, supply &
maintenance of software.
ISO
9000-4
Model for quality assurance in final inspection & test:This applies to contracted arrangements that rely on a
suppliers ability to detect control non conforming products by final testing
& inspection. It is difficult to perceive to Situation where this would apply
within the pharmaceutical industry, where quality must be built in to design
& production of the product.
V. ISO 9004: Quality management & quality system elements
Like ISO 9000 it is a descriptive document which provides more
detailed guidance on the quality elements included in the registration or
certification standards ISO 9000, ISO 9002, & ISO 9003.
SUB CLASES OF ISO 9004:
SUB
WHAT IT DEALS
CLASSES
ISO9004-1
General Guidelines
ISO9004-2
ISO9004-3
ISO9004-4
ISO9004-5
ISO9004-6
ISO9004-7
ISO9004-8
3. CONTRACT REVIEW:
A contract should exist between the suppliers and the manufactures
that clearly defines the Quality requirements and assures that the suppliers
have the ability to meeting its requirements.
4. DESIGN CONTROL:
ISO 9000 provides extensive guidance regarding design control.
ISO 9000 series supersedes c-GMP in design control. It involves the
conversion of customer needs to final products. Each and every step in the
design/development process is monitored to assure the quality of the final
product. This level of control during product design and development is not
included in the cGMP.
5. DOCUMENT CONTROL:
It involves the effective control of approved documentation from
initiation, issue to use. Obsolete documentation must be removed from the
operation and change over procedures is required.
6. PURCHASING:
It defines how to assure the quality of purchased materials and what
are the steps to be taken for the steps to be taken for the selections of sub
contractors. C-GMP only address from receipt of purchased materials
onwards.
7. CONTROL OF CUSTOMER SUPPLIED PRODUCTS:
Customer means sub contractors. There should be proper control
over the customer supplied products, which are used in the formulation of
products and proper record should be maintained.
- green
Rejected
- red
System audit: to check activity that can affect final product quality.
2)
16.TRAINING:
Training is required for all the personnel, who are engaged in
quality related activities and record are to maintained. ISO 9004-1 refers to
the importance of motivations quality awareness measurement an
recognition of performance. None of these important features are included in
the GMP.
17.SERVICING:
There should be procedures to evaluate and report on performance.
18.STATISCAL TECHNIQUES:
Statistical techniques are applied to verify process capability and
product characteristics.
There are various statistical techniques like:
1) Design of experiments and factorial analysis.
2) Analysis of variants (ANOVA).
Which are carried out in various fields like market analysis, product
design, stability, process controls and capability, sampling and data analysis.
Application accepted
Documentation review
Pre assessment
Registration audit
Registration decision
Po
Registration Periodic survey of quality system
Surveillance
4)
6)
7)
occurrence.
8)
medicines.
3)
4)
5)
6)
2)
3)
Improved morale.
4)