Quality Assurance

ELM Pharmaceutical Consultancy

ELM  provides its services to different industries that are regulated by GXP Regulations such as pharmaceutical industries, manufacturers of Active Principles, excipients and packaging material, cosmetics manufacturers, or those companies related to these industries such as analysis laboratories, distribution laboratories, equipment manufacturers and software manufacturers.

The services that ELM can provide are very varied and extensive, and can be grouped, but not limited to the fields listed below:


ELM helps any industry in the GXP environment to improve the Quality System of the company:

Quality Manual, Technical Memory, Site Master File.

Preparation of inspections by authorities

Document management: Procedures, protocols, reports, etc.

Management of Quality tools: Self-inscriptions, deviations, Product Quality Review, etc.

The improvement of the Quality System starts with a review of the current status and the proposal of an Improvement Plan. The implementation of the Improvement Plan must be accompanied by the edition of the procedures and the necessary training. Always, at the request of the client, the follow-up of the improvement is performed by out team.


Risk Management is a requirement of the GMP and ISO standards. The implementation of which can be done with different approaches.

ELM can collaborate with the client to implement Risk Management activities according to the criteria of the European GMP.

The different points that can be introduced are:

General implementation of the system.

Risk Management in the quality system: Complaints, deviations, out of specification results, batch recalls, etc.

Prioritization of qualification, validation, maintenance and/or audit tasks.

In all cases, the corresponding training and the implementation of standard work procedures must be performed. If applicable, the necessary statistical and risk management tools will be used, for example: AMFE, AMFEC or APPCC among others.


ELM provides “In-company” training courses adapted to the needs of each client. All courses are adapted to the client, taking into account the particularities of the company quality System, organisation and Standard Operating Procedures (SOPs) to avoid contradictions in vocabulary and organisation.

Courses are given on all aspects of the GXP and ISO Standards applicable to the pharmaceutical, chemical-pharmaceutical, cosmètics and food suplements.

The courses are performed with the didactic and audiovisual tools necessary to obtain the greatest benefit from the course. In addition, the courses are evaluated to meet the training requirements evaluated according to GMP criteria.


Sampling and control of lots is not always sufficient to ensure the quality of the product manufactured and the raw material or component used.

In this case quality audits, whether internal or external, help to have enough information to ensure the quality of the product received.

ELM brings the experience of years performing internal audits (self-inspections) and audits of suppliers of raw materials, components, pharmaceutical products and services, mainly conducted in Spain, Europe, Asia and America.


ELM offers its collaboration in the management, programming and performance of validations and qualifications in the different fields required by the GXP regulation:

Production process validation.

Cleaning validation.

Validation of analytical methods.

Validation of Computer Systems: ERP, LIMS, Documentary Systems, Control Systems, etc.

Qualification of Production and Quality Control Teams.

Monitoring and mapping of warehouses, sample libraries, etc.

 All the validations and qualifications are performed following the corresponding international regulations, the life cycle and a risk analysis.