Medichem

Our Quality Assurance unit is responsible for involving the whole Medichem team in the effort to improve the quality of our products and processes, starting with the R&D process –thus building quality into the design stage– and continuing throughout the entire life cycle. We remain focused on clients and we are happy to provide them with the services and assistance they need during the development/registration stage and later during the commercial stage, as well as preparing the requested products they need for their particular requirements in terms of specific quality attributes.

GMPs are strictly adhered to, and significant resources are devoted to the validation effort. Manufacturing processes, analytical and cleaning methods are fully validated. Critical systems are also validated and equipment is qualified. Quality risk management principles are applied to facilitate the development effort and quality improvement.

FDA Inspections

Since 1985, our plant in Celrà has been regularly inspected and found acceptable by the FDA.

During our last four inspections, no form 483 was issued (no observations were noted), underlining our commitment to the highest quality.

The latest inspection of our Spanish plant in Celrà (Girona) in April 2009 was carried out by a small team of FDA officers and covered general GMP systems, as well as five different APIs.

With this outcome Medichem became part of an exclusive group of pharmaceutical companies that completed four consecutive inspections without any observation.

Since 1985 we have been inspected on these dates:

• 1985 December
• 1987 October
• 1991 October
• 1994 March
• 1994 November
• 1997 April
• 1999 November: no form 483
• 2002 April: no form 483
• 2006 November: no form 483
• 2009 April: no form 483

The Malta plant in Hal Far started operations in November 2005 and received FDA approval in February 2008.

ISOs

Medichem Spain has been certified according to ISO 9001 since 1996, last follow-up audit was carried out in April 2009.

Medichem Spain is certified as well according to ISO 14001 since 2001. Follow-up audit according to the New Version (2004) was carried out in April 2009.

ISO 9001 certification was obtained for our plant in Malta in 2007.

Audits

To assist our clients in a better way, important resources are allocated to allow them to become familiar with our quality system, procedures and facilities through visits to our manufacturing site and through audits. Our experience and organisation in this field allows our customers’ officers to obtain a huge amount of information in relatively little time.

Cooperation

Medichem is proud to contribute to the effort of setting appropriate standards for the industry. We actively participate in national and international organisations which develop or contribute to the development of guidelines and regulations in the fields of GMP, quality, regulatory affairs, environment and safety.

Medichem is also very active in the development of up-to-date standards for APIs through strong cooperation with US Pharmacopeia (USP) and European Pharmacopoeia (EP). The collaboration includes the supply of materials for reference standards, information and comments on analytical methods, collaborative trials for establishment of quantitative reference materials and for qualification of testing methods, and participation of members of our staff as experts in pharmacopoeial working groups.

Medichem offers active ingredients according to the highest standards of quality, manufactured with the guarantee that our Quality Assurance system applies the cGMP and ISO 9001 standards.

We work towards exceeding our clients’ expectations, with a view to offering them flexibility in terms of service, ongoing communication and reliability.

Our intention is to ensure that each and every one of our products meets the applicable pharmacopoeial specifications, as well as those of our clients. We offer both clients and Health Authorities technical advice related to process development, quality control and documentary tasks.

Since 1985, our high quality standards have made it possible for us to market our products in the USA. That same year we obtained the first approval of the reputed American FDA, and our products are inspected regularly by this authority. This effort to maintain ongoing quality over time can be seen in the last four inspections made by this authority, which gave a no form 483 result (no observations were noted).

Our quality control services include:

• development and validation of analytical methods
• testing for stability studies
• sampling and analysis of products (raw materials, intermediates and final products)
• analysis of standards and impurities
• analytical support for production and development work

Our quality control laboratory is equipped with the following state-of-the art instruments:

• FTIR
• UV/Vis
• HPLC (reverse phase, normal phase and ionic chromatography)
• HSGC
• GC capillary
• Polarimetry
• Potentiometric and K.Fischer automatic titratrors
• Particle size determination by laser diffraction
• Particle size (air-jet sieve)
• Muffle furnaces and ovens

The Regulatory Affairs department is responsible for drafting, editing and submitting all necessary documentation to the regulatory Health Authorities, offering expert knowledge and broad experience regarding regulations on APIs, which ensures that our customer products reach the market quickly. The Department is committed to satisfying the requirements of the Health Authorities worldwide quickly and efficiently.

Regulatory Affairs department works in constant collaboration with our Research, Development, Production and Quality Control Departments as well as with the worldwide Regulatory Agencies and is in permanent liaison with clients to reduce the regulatory time limits to a minimum.

Our expertise in Regulatory Affairs enables us to meet the growing demands of the world’s Health Agencies with regard to the quality of the Drug Master Files (DMF). One of the main tasks of the Department is to keep abreast of the Regulations regarding APIs and to work to ensure that Medichem products are compliant with the worldwide pharmaceutical regulations. Regulatory Affairs collaborates with industry associations such as APIC and EGA on the regulations that affect our industry.

Its work has led to more than 460 regulatory submissions (DMFs) to the regulatory bodies of the United States, Europe, Canada, Australia and New Zealand as well as 6 Certificates of Suitability (CEPs) granted by the European Pharmacopeia. Since our first inspection by the FDA in 1985 we have submitted about 44 DMFs in the USA, of which more than 35 are still active.