Quality Control

|   Services for third parties  |

Quality Control Laboratory

Our Quality Control Laboratory (GMP Certified) specialises in all forms of analysis affecting the pharmaceutical, para-pharmaceutical, cosmetics and food industries. It is made up of pharmaceutical technicians with more than 10 years’ experience in this area, and complete expertise in all analytical and regulatory techniques involved in what is a highly sensitive and specialist task.

Technology

At Puerto Galiano we have a laboratory equipped with the very latest equipment and resources for the quality control of the raw materials and ingredients used in our production of drugs/cosmetics, and our contract manufacturing for third parties, while also guaranteeing quality during the various phases of the production process and the finished product.

The laboratory has a MICROBIOLOGY Section equipped with all the facilities required to conduct microbiological product controls (drugs/cosmetics/foodstuffs/water) and environmental controls.

It also has climate-controlled chambers to perform Stability Studies in accordance with ICH standards.

Analytical Techniques

Physical-chemical :

  • Liquid chromatography (HPLC).
  • Thin-layer high-resolution chromatography (Densitometer).
  • Dissolution test.
  • Total Organic Carbon (TOC) detection.
  • UV/VIS spectrophotometry.

Microbiological :

  • Dilution and direct seeding.
  • Filtration.
  • Detection of pathogenic microorganisms.
  • Microscopic observation.

Drug Analysis

Our solutions:

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Our services:

  • Analysis of raw materials in accordance with Ph.Eur. (PHYSICAL-CHEMICAL and MICROBIOLOGICAL).
  • Control of Medicinal Plants: thin-layer identification, determination of ash, metals and moisture. (PHYSICAL-CHEMICAL and MICROBIOLOGICAL).
  • Analysis of conditioning material (PHYSICAL-CHEMICAL).
  • Analysis of Finished Product (PHYSICAL-CHEMICAL and MICROBIOLOGICAL).
  • Stability Studies (ICH, in progress).
  • Cleaning Validations (by TOC or other analytical techniques).
  • Validations of Analytical Methods.

Cosmetics Analysis

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Our services :

  • Microbiological control of cosmetics products at all stages of production, raw materials, bulk products and finished products, so as to guarantee compliance with the legislation in force, and hence consumer safety.
  • Total Viable Microorganisms Count.
  • Detection of Pathogens.
  • Physical-chemical tests of cosmetics products (quantification of active ingredients).

Food Analysis

Our solutions :

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Our services :

  • Microbiological and Physical-chemical control of foodstuffs as a fundamental section of HACCP systems.

Water Analysis

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Our services :

  • Physical-chemical tests: Colour, odour, taste, turbidity, pH, conductivity, ammonium, nitrates, etc.
  • Microbiological tests: Aerobic organisms, total coliforms, Escherichia coli, etc.
  • Total Organic Carbon (TOC)

Air and Surface Analysis

Our solutions :

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Our services :

  • Consumed air quality control from the microbiological perspective in manufacturing rooms and analysis of drugs/healthcare products/cosmetics/foodstuffs.
  • Surface quality control from the microbiological perspective in manufacturing rooms and analysis of drugs/healthcare products/cosmetics/ foodstuffs.
  • Aerobic Microorganisms Count.
  • Mould and Yeast Count.

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