Quality Assurance

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Quality Assurance Department

Our Quality Assurance Department provides the most appropriate solutions for any issue involving installations, application of GMP standards, etc. Without overlooking the preparation of application dossiers, installations audits, training courses, preparation of quality documentation, etc.

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Staff Training

We provide technical GMP training.

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Consultancy in Pharmaceutical Installations

Applications for new Pharmaceutical Laboratories or Warehouses

We draw up all manner of applications to the AEMPS connected with the new registration of a Pharmaceutical Laboratory or Wholesale Warehouse, including plans, Quality Manual, appointment of Technical Director, etc.

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Preparation of the Site Master File

Authoring and updating of the Site Master File in accordance with the latest AEMPS demands in this regard, following the instructions of the Sub-Directorate-General for Medications Inspection’s “Guide to the Content of the Site Master Files of Pharmaceutical Laboratories”, of July 2008.

Preparation of Standard Operating Procedures (SOPs)

Preparation of SOPs for all types of management, whether Manufacturing, Control and Quality Assurance, Warehouses, etc., for any destination: Site Master File, internal organisation of the Laboratory, etc.

Execution of Audits/Approval of Suppliers

PUERTO GALIANO conducts all manner of audits of pharmaceutical companies, third-party manufacturers, raw materials suppliers, etc.

Process Validations

For Manufacturing, Cleaning Processes, Equipment Qualifications: all forms of validations are conducted for manufacturing processes, retrospective renewals, validations of manufacturing equipment cleaning processes, manufacturing equipment qualifications.

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Annual Product Review

Annual product review reports are drawn up, with statistical approaches. Preparation of Standard Operating Procedures (SOPs).

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