GMP services

_ DQ, IQ, OQ, PQ_ CSV IQ, CSV OQ_ Process validation_ GMP Consulting

Factory and Site Acceptance Test (FAT/SAT)

Documented acceptance tests at the supplier/customer’s

location with test log, test summary, list of outstanding issues

and release certificates.

Test Specification (TS)

Description of purpose, implemen-

tation and acceptance criteria of

the various qualification tests.

Installation Qualification (IQ)

Identification of the plant, checking of the mechanical design,

installed components, the GMP documentation, drawing tests,

the electrical system, wiring (5% diagram test), the GEP

documentation and visualization masks.

Operational Qualification (OQ)

Review of the safety equipment, functional testing of individual

components, checking of the warning and error messages,

screen navigation, key functions and password level as well as

the input parameters.

Quality and Project Plan (QPP)

This determines how the quality requirements of the project

are met. Activities to be performed, scheduling, responsibili-

ties, applicable control mechanisms and operational elements

are regulated.

Design Specification (DS)

The establishment of a technical

basis and the specification of the

current conditions that should be

taken into account in terms of design,

construction and installation. This

ensures that all customer require-

ments and the current standards

of cGMP, EU, ISO and FDA are met.

Risk Analysis (FMEA)

A systematic approach that detects potential problems and

estimates their risks with the help of so-called risk priority

numbers, in order for countermeasures to be taken. The FMEA

allows the machine supplier to assess the risk of its construc-

tion and to increase the safety of the production process of

the customer.

The GMP qualification for production, assembly and testing

processes must be fulfilled especially in the medical and

pharmaceutical industry. The qualification makes it necessary

to have an advanced GMP-compliant qualification documentation

to one’s disposal in addition to the technical plant documenta-

tion. In addition we offer individual ways, all of which are com-

pliant with the current international standards. If required,

you can count on our active support in the area of qualification/

validation. In addition, we also provide a complete GMP package

(DQ, IQ, QQ) with protocol preparation, test procedures and

result documentations.

Full power ahead for GMP qualification

DQ, IQ, OQ, PQ

From the creation of technical and functional specifications,

the implementation of risk analysis and the preparation

of specifications to the planning and realization of the indi-

vidual qualification steps we will completely take over

the implementation.

FAT/SAT

With regard to the plan and final

inspections of the machinery and

equipment, we offer to establish

the necessary documents and the

implementation of the respective

inspection.

Re-Qualification and retrospective Qualification

In the event of changes to the system, we assist you in the

necessary re-qualification procedure to ensure that your

equipment meets the standards within the shortest possible

time. We will provide you with the necessary documents

needed for retrospective qualification for in-use equipment.

Qualification reviews and examination of documentation

We take care of all the required work to undergo your existing

qualifications required by the review.

We are here to assist you with the following specialties:

Do you have all documents in place and wish them to be exami-

ned by experts? Just contact us. Our experienced specialists

would be delighted to assist you.

We look forward to hearing from you!

Contexo GmbH

Herrenäckerstraße 7–9

73650 Winterbach

Phone: +49 (0) 7181 606-100

Fax: +49 (0) 7181 606-150

E-Mail: info@contexo-gmbh.de

www.contexo-gmbh.de