Our process

Description of validation / qualification process

image/svg+xml Audit Audit Risk Analysis Risk Analysis Validation Plan Validation Plan Validation Validation Validation Report Validation Report Supplier Audit Supplier Audit Infrasturcture Qualification Infrasturcture Qualification Testing / Examination Plan Testing / Examination Plan Testing / Examination Testing / Examination Testing / Examination Report Testing / Examination Report Qualification Plan Qualification Plan Design Qualification (DQ) Design Qualification (DQ) Factory Acceptance Test (FAT) Factory Acceptance Test (FAT) Site Acceptance Test (SAT) Site Acceptance Test (SAT) Installation Qualification (IQ) Installation Qualification (IQ) Operational Qualification (OQ) Operational Qualification (OQ) Process Qualification (PQ) Process Qualification (PQ) Qualification Report Qualification Report Maintenance Maintenance

The chart above illustrates the model approach to process / system validation.

The different stages of validation and qualification are selected to suit the project at hand, and agreed on with the customer.

In regard to each qualification and validation project, we design:
  • a Traceability Matrix, which shows the link between the user’s requirements, the technical documentation and the tests performed;
  • a Validation Register, which contains a list of documents (technical documents, validation documents, procedures, manuals, training materials, etc.) created during the validation process.
The chart does not contain information about the technical documents to be created by the client or supplied by the vendors. These include, among others:
  • User Requirements Specification
  • Functional and technical specifications (applicable to IT);
  • Operating and maintenance manuals, technical drawings, electrical diagrams, pneumatic diagrams, P&IDs, etc. (concerning equipment and installations)
  • Technology instructions, cleaning procedures, etc. (concerning process validation)
  • Validated state maintenance procedure (change control, document management, inspection schedules, APRs, etc.)
See a short description of each of the stages we handle by placing the cursor over it.

We perform all our projects on the basis
of the following laws and regulations::


1. Food and Drug Administration (USA):

  • 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs; General (Pharmacy)
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (Pharmacy)
  • 21 CFR Part 820 – Quality System Regulations (Medical Device)
  • 21 CFR Part 11 – Electronic Records, Electronic Signatures ( Pharmacy i Medical Device)

2. European Medicinal Agency (EMA):

  • EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines
  • European Comission Council Directive 93/42/EEC
  • ISO 13485 – Medical Devices
  • ISO14644-1 Cleanroom Standards

3. Polish Laws and Regulations:

  • Regulation of the Minister of Health of 9 November 2015 on the Requirements of Good Manufacturing Practice along with later changes
4. Industry Guidelines:

  • Quality Management Systems – Process Validation Guidance (GHTF/IMDRF)
  • ICH Guideline: VALIDATION OF ANALYTICAL PROCEDURES:TEXT AND METHODOLOGYQ2(R1)
  • ICH Guideline: GOOD MANUFACTURING PRACTICE GUIDE FORACTIVE PHARMACEUTICAL INGREDIENTSQ7
  • ICH Guideline: PHARMACEUTICAL QUALITY SYSTEMQ10
  • PIC/S GMP GUIDE
  • PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS)
  • PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS)
  • PIC/S GMP GUIDE (ANNEXES)
  • ISPE Good Practice Guide: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • ISPE Good Practice Guide: A Risk-Based Approach to Electronic Records and Signatures
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
  • ISPE Good Practice Guide: IT Infrastructure Control and Compliance
  • ISPE Good Practice Guide: Global Information Systems Control and Compliance
  • ISPE Good Practice Guide: Good Engineering Practice
  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
  • ISPE Baseline Guide Volume 5: Commissioning and Qualification
  • ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
  • ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities (PACLAW)
  • ISPE Good Practice Guide: Process Gases
  • ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Second Edition)
  • ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)

Our consultants worked for such industries as:

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Information Technology:

Silicon & Software Systems (S3Group)

ITQ MEDIA/Innovation Technology Group S.A

Asseco Poland (Commercial Insurance Division)

Streamsoft

ITProjekt

Selvita S.A

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Pharmaceuticals and
Medical Products 
:

Roche Polska Sp. z o.o.

Z.F. Polpharma S.A.

TEVA Operations Poland

Mylan Global Respiratory Research & Development

Agila Specialites Polska

Takeda Ireland ltd.

3M HealthCare Business

Arjohuntleigh Poland, Getinge Group

PPF Hasco-Lek S.A.

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Household Appliances:

Electrolux Polska

Whirlpool Polska

 

 

We are now providing our services for
more than 20 various systems / projects in the area of:

ERP

SAP SD, SCM, FICO modules
Supply Network Collaboration
Batch Tracing
Cloud SaaS solution
Labelling Management

OTHERS

EDMS system
Supply Chain
Drug Safety
Integration Platforms
Database Tools