QUALIFICATION AND VALIDATION

The Good Manufacturing Practices, commonly known as GMP, ask drug manufacturers to prove with document the control of the critical aspects in equipment, systems, facilities and processes, with the aim to ensure the quality of the manufactured product, the security that this product will not cause any harm to the patient and the integrity of the critical data of the process.

At COMSER we determine the reach of the qualification or validation through a risk evaluation, which lets us identify the critical aspects of the equipment, facilities or information systems and define the qualification and/or validation tests needed to ensure the compliance of both the requirements of the client (URS) as well as the regulatory requirements.

Afterwards we take care of the elaboration of the qualification and /or validation protocols, as well as the execution of the tests included in these protocols and previously determined in the risk evaluation.

Finally we issue a report where we detail the qualification / validation tests performed as well as the result obtained in each of them.

cualificacion-y-validacion
FACILITIES AND EQUIPMENT QUALIFICATION

Depending on the size f the projetc, COMSER provides its customers with the following documentation:

  • Qualification plan.
  • Risks analysis
  • Design qualification (DQ).
  • Installation qualification (IQ).
  • Performance qualification (OQ).
  • Qualification reports.
PROCESS VALIDATION

We adapt to the methods and work procedures of our clients to draft both the protocols as the final validation report.

  • Validation of the sterilization processes.
  • Validation of the sanitization processes.
  • Validation of the cleaning processes.
  • Validation of the manufacturing processes.
VALIDATION OF THE COMPUTERISED SYSTEMS

The implementation of the computerised systems in critical processes within the industry regulated by the GMP is up to date. The validation of these systems is essential to ensure the compliance of the user´s requirements and the demands of the regulatory bodies.

The main regulations applied to the computerised systems used in the industry regulated by the GMP are:

EU GMP Annex 11: Computerised systems.

FDA 21 CFR Part 11: Electronic records; electronic signatures.

The GAMP 5 guide (the most recent version) classifies the types of software in the following categories:

  • Category 1: Infrastructure software.
  • Category 3: Non-configured products.
  • Category 4: Configured products.
  • Category 5: Personalized applications.

Depending to the category to which it belongs and depending on the risks analysis, the GAMP guide enables the definition of the strategy and the steps to follow in the validation of the software.

COMSER has the necessary experience and the knowledge to help our customers achieve the compliance of their computerized systems with the necessary requirements in the most efficient and simple way.

Our computerized systems validation service includes:

Risks analysis.

Draft of the validation plan (VMP).

Draft of the validation protocols.

Execution of the validation protocols.

Preparation of the validation reports.

Compliance audit of the regulation 21 CFR Part 11.

Compliance audit of the Annex 11 of the EU GMP.

THERMIC VALIDATIONS

For the correct validation/qualification of the thermic behaviour of certain equipment and processes it is required to have the knowledge, experience and the appropriate test equipment.

At COMSER we have all the necessary ingredients to offer a high-quality thermic validation service. Among the equipment / processes that we verify there are:

Depyrogenation tunnels:

  • Distribution test of temperature with empty chamber.
  • Distribution test of temperature on load.
  • Penetration test of temperature on load.

Lyophilizers:

  • Mapping test of plate temperature off load.
  • Distribution test of the temperature in sterilization test.
  • Mapping test of the plate temperature on load.

Autoclaves:

  • Distribution test of the temperature off load.
  • Distribution test of the temperature on.

Others:

  • Mapping in equipment with controlled temperature: vacuum, drying and incubation oven, fridges, freezers and deep freezer.
  • Mapping of reactors.
CALIBRATIONS OF THE MEASUREMENT LOOP

The calibration of the measurement loops of critical processes is an essential activity to be able to characterize the error in the measurement elements. Based in this information it will be possible to take decisions on the reliability of the information of the process that each of them is giving.

AT COMSER we have the appropriate tools to perform the calibration of the measurement loop in situ including traceable patters by ENAC, NIST or similar.

  • Calibration of the temperature loops.
  • Calibration of the pressure loops.
  • Calibration of the vacuum loops.