The strict regulation surrounding the pharmaceutical and cosmetic industry and its suppliers demands the implementation of a management system focused clearly and vividly on regulatory compliance.

COMSER offers to clients its knowledge and experience of more than 25 years working in the sector.

QUALITY SYSTEMS
RISK MANAGEMENT

Depending on the focus of the project, at COMSER we work together with our clients in the drafting, review and modification of the following documents and/or procedures.

  • Quality manual, technical report, Site Master File, etc.
  • Preparation of the official inspections.
  • Document management: procedures, protocols, reports, etc.
  • Management of the quality tools: Self-inspections, deviations, incidences, review of the quality of the product, etc.

The improvement of the Quality System starts with a review of the current state and a proposal of an improvement plan. The implementation of the improvement plan must come with the edition of the procedures and the necessary training. Always, at the customer´s request, there is a follow up of the improvement.

The management of the risks is a requirement of the GMP regulation and the ISO standard. The implementation of these can be done with different approaches.

At COMSER we collaborate with our customers to implement the Risk Management following the criteria established in part III of the European GMP.

The most common points to be introduced are the following:

  • General implementation of the system.
  • Risk management in the Quality System: Complaints, deviations, out of specifications results, recall of batches, etc.
  • Prioritization of the qualification tasks, validation, maintenance and/or audits.

In all cases the appropriate training must be performed as well as the implementation of the normalised working procedures. When needed, statistics and risk management tools will be used, for example: AMFE, AMFEC o APPCC among others.

TRAINING

Performance of “in company” training courses adapted to the needs of each customer. All the courses are tailor-made taking into account the organization where the training will take place.

There are courses on all the aspects of the GMP and ISO regulation that are applicable to the pharmaceutical, chemical-pharmaceutical, cosmetic and food industries, among others, both on Quality as well as Organization Management, but also within the perspective of the Regulation. Courses are also given on Quality Control and on each of the tools of the Quality System.

The courses are performed with the didactic and audio-visual tools needed to obtain the most of the course. In addition to this, the courses are evaluated to meet the requirements of the training evaluated according to GMP regulations.

Courses given recently:

  • General GMP training and specific for the Production, Quality Control, Maintenance and Warehouse departments.
  • Training on Good Distribution Practices (GDP) for Medicines, Active Ingredients, Medicinal Gases, etc.
  • Training on Qualification of equipment and facilities.
  • Training on validation of informatics systems (GAMP 5).
  • Training on criteria 21 CFR part 11 and Annex 11 of the GMP.
  • Training on equipment calibration and Quality Control equipment.
  • Introduction to Quality by Design.
  • Quality tools to increase productivity.
  • Validation of the cleaning of the facilities and production equipment.
  • Selection/homologation of the suppliers.
  • Validation of the analytical methods.
  • Course on UV-visible Spectrophotometry.
  • Course on near infrared (NIR) Spectrophotometry.
  • Course on the Product Quality Review (PQR).
  • Management of the incidences according to Risk management (Part III of the cGMP).

The courses are done with the didactical and audio-visual tools needed to obtain the most of the course. In addition to this, the courses are evaluated to meet the requirements of the training evaluated according to GMP criteria.