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GMP
Services

PRO MSR GmbH is a long-standing partner of the pharmaceutical industry. We provide the majority of our services in this area.
The focus of our activities in the regulated environment is on systems and machines requiring qualification.
Our extensive experience enables us to realize pharmaceutical machine or plant projects in various areas or in special pharmaceutical machine construction. The same applies to the cosmetics and food industries.
The focus of our activities in the regulated environment is on systems and machines requiring qualification.
Our extensive experience enables us to realize pharmaceutical machine or plant projects in different areas or in special pharmaceutical machine construction. The same applies to the cosmetics and food industries.
We offer software validation in the pharmaceutical environment - validation approach according to GAMP 5. For the validation of computerized systems in the pharmaceutical production environment, we use the pragmatic approach of the GAMP 5 guideline "A Risk-Based Approach to Compliant GxP Computerized Systems" of the ISPE.
We support our customers from the start of their project planning throughout the entire life cycle of the system or automation solution with our range of services specially tailored to this area. We work in strict compliance with the relevant guidelines of the responsible authorities and regulations such as FDA, GxP and GAMP.

What is GMP
Complete package for compliant operating procedures - GMP stands for "Good Manufacturing Practice". This is regulated by various national and international regulations and guidelines. It ensures that pharmaceutical products are manufactured consistently in accordance with defined quality standards and that guidelines for quality assurance of production processes and environments are adhered to in the production of medicinal products and active ingredients, as well as for cosmetics, food and animal feed. Among other things, GMP focuses on the requirements for hygiene, premises, equipment, documentation and controls. GxP has established itself as a further term that summarizes all guidelines for "good working practice". It is particularly important in medicine, pharmacy and pharmaceutical chemistry. The "G" stands for "Good(e)" and the "P" for "Practice", the "x" in the middle is replaced by the respective abbreviation for the specific area of application.
What is GAMP
Good Automated Manufacturing Practice - GAMP is intended to serve the efficient creation and operation of computerized systems that meet the regulatory requirements of a GMP environment. It introduces a common terminology, promotes a risk-based and lifecycle-oriented approach and clarifies responsibilities.
Validation
Validation provides documented proof that a process or system meets the previously specified requirements in a reproducible manner in practical use.
GMP-Guidelines
GMP guidelines require that every single ingredient in the manufacture of a pharmaceutical product must be documented and traceable at all times.
GMP guidelines define the introduction, evaluation and classification of computerized systems and specify how electronic records and signatures in computerized systems are to be handled by observing criteria for system validation, audit trails, user management, documentation and, in particular, data integrity.
We ensure that our systems and solutions for the pharmaceutical, cosmetics and food industries meet these requirements.
GMP-validation for quality right from the start
We consider pharmaceutical processes across the entire life cycle and beyond system boundaries. This also includes products, systems, solutions and services in accordance with GAMP (Good Automated Manufacturing Practice).
In addition, further consideration after the implementation of a system at the end of the qualification phases (IQ/OQ/PQ..) is also of fundamental importance.
Data integrity - a buzzword with immense significance and far-reaching consequences and obligations. The topic ranges from the entry and recording to the long-term archiving of relevant data.
Products, solutions and services for GMP
We adjust our solutions to your requirements, enabling you to follow a structured qualification and validation concept right from the start. This provides you with products, systems and solutions that comply with regulatory requirements and GAMP recommendations - from sensors to the cloud.

GMP ENGINEERING - Validation

The basic procedure - the V-model. The Guide to Good Manufacturing Practice Part I defines the terms validation and qualification as follows:
  • Validation
    „Proof, in accordance with the principles of good manufacturing practice, that procedures, processes, equipment, materials, operations or systems actually lead to the expected results."
  • Qualification
    „Proof that equipment works properly and actually produces the expected results. The term validation is sometimes extended to include the concept of qualification.“
The approach presented here is based on the V-model, as described in the GAMP 5 guideline "A Risk-Based Approach to Compliant GxP Computerized Systems", among others.
In this validation approach, the specification, which can be single or multi-level (e.g. user specification, functional specification and configuration specification), is checked with appropriate qualification measures.
The validation is intended to prove the suitability of the system for the intended purpose and to demonstrate compliance with the applicable regulations. In this approach, the qualification part (on the right-hand side of the diagram below) checks whether the implemented software is installed and working as planned.
The procedure within the V-model can be divided into different phases. On the left-hand side of the V-model you will find the specification phase, on the right-hand side the qualification phase. The implementation of all validation activities must be planned in advance as part of an agreed validation plan based on the company's validation master plan.
PRO MSR - scope of delivery and Documentation
We support you with applications and services developed specifically for your application, from the initial idea to the fully qualified/validated system solution. This is always done in compliance with the relevant guidelines and regulations combined with your additional internal requirements and guidelines. We provide a correspondingly coordinated documentation management system.
Documentation is extremely important in the regulated pharmaceutical environment. Any automation solution is only as good as its documentation and the associated version management.
We create the necessary documents for qualification and technical documentation.
The following is an excerpt of related services in the form of planning, consulting, design and documentation:
Qualification/Validation
  • Specifications - User requirement specification (URS)
  • Target specification
  • Functional Design Specification
  • Hardware Design Specification
  • Software Design Specification
  • Software Module Test
  • Software Integration Test - SIT
  • Hardware/control cabinet FAT (Factory Acceptance Test)
  • Software FAT (Factory Acceptance Test)
  • Hardware Installation
  • Signal test SPS
  • Side Acceptance Test - SAT
  • Installation Qualification - IQ
  • Operation Qualification - OQ
  • Calibration protocols and instructions

Life cycle

  • Control description
  • Operating instructions
  • Parameter lists
  • Fault report lists
  • E-CAD
  • System Recovery
  • Parameterization values and setting values
  • Manuals and data sheets
  • Version management and revision management
  • Software documentation
  • Software Revisionsmanagement / -history
  • Setup documentation and installation documentation

  • User- and password-documentation

  • Operation Qualification - OQ
  • Calibration protocols and instructions
PRO MSR Automatisierungs GmbH
Sägleithe 16
95119 Naila / Germany
+49 (0) 92 82 / 14 37
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