CERTIFICATES, STANDARDS AND AUDITS

Identification certification card of the company

  IMS POLICY

History of certificates

In 1997-1999, Alkaloid, being a leader in the region and wider, was among the first companies which certified the Quality Management Systems of the Profit Centers (Pharmaceuticals, Chemistry, Cosmetics and Botanicals), in accordance with the international ISO 9001 standard. In 2000-2001, Alkaloid was already the first company in Macedonia to be awarded with certificates for Environment Management Systems that conform to the international ISO 14001 standard for the profit centers Botanicals and Pharmaceuticals. All ISO certificates were issued by the certification body Quality-Austria (former ÖQS) and accredited by IQNet -The International Certification Network.

In 2002, Alkaloid started its new factory for production of solid oral dosage forms, built in compliance with European and international GMP requirements. Confirmation for this compliance was that it obtained the first GMP certificate that any  Macedonian producer of drugs has ever been awarded with by the Macedonian Ministry of Health. Alkaloid also received a GMP certificate for its new factory for production of cephalosporins.

Launching the new section for drug packaging in March 2005, Alkaloid-Pharmaceuticals confirmed the GMP Certificate from the Macedonian Ministry of Health, compliant to the EU 2001/83/ЕС and 2003/94/ЕС Directives and WHO Guidelines. During the same year, the new microbiology laboratory was also put in operation, and the other laboratories for Quality Control were refurbished.

Starting in 1998, the Botanicals program was verified with the first certificate in organic production methods as compliant with the EU 2092/91 Directive by the Control Union Certifications (former SKAL)-Netherlands, which is the first of this kind on the Balkans. The international significance of the certificates for organic production methods has been confirmed on three continents by verification in accordance with The National Organic Programme of United States Department of Agriculture and Organic JAS-Japanese Agricultural Standards by the Control Union Certifications-Netherlands. In 2010 the “FairWild” certificate confirmed that the products from the tea category are compliant with the requirements of the principles of Fair Trade, the International labour standards and International Standards for Sustainable Wild collection of medicinal and aromatic plants, which guarantee safety, quality and efficiency of the teas produced.

The production of medical devices – concentrated solutions for hemodialysis and X-ray film – the Chemistry program was awarded with CE certificates in 2007-2010 by the renowned KEMA Quality agency B.V. part of the DEKRA Group from Netherlands. The Chemistry – Medical Devices Program from the profit center of Chemistry Cosmetics Botanicals of Alkaloid AD Skopje was awarded a Quality Management System Certificate for the introduction of and meeting ISO 13485:2003 Standard Requirements.

In 2012 Quality Austria carried out the first matrix Audit of Alkaloid’s Integrated Management System (IMS) and confirmed its conformity with the international ISO 9001 and ISO 14001 standards (100% of the sites, production facilities and processes) for ALKALOID AD, ALKALOID CONS DOOEL, ALKALOID d.o.o. BELGRADE and ALKALOID VELEDROGERIJA d.o.o. BELGRADE, the conformity with ISO 13485 for the profit center of Pharmaceuticals and the program of Chemistry, as well as complete adherence to HACCP’s principles and requirements for the Botanicals program and PC Pharmacy.

The environmental concerns are one of the long-term principles of Alkaloid AD – Skopje’s business policy and the environment management system is part of its integrated management system. In 2012 the Ministry of Environment and Physical Planning awarded the PC Pharmacy site in Avtokomanda with an A - permit for conformity with operational plan for integrated pollution prevention and control, including Alkaloid among the corporate responsible companies that, in the course of their production operations, care about the integrated pollution prevention and control.

INTEGRATED management SYSTEM

The development and improvement of regulations, standards and guidelines resulted in integration and continuous improvement of the Integrated Management System (IMS). Alkaloid’s IMS is an important system of corporative and specific procedures and policies for Alkaloid’s AD head office and related subsidiaries/offices. The Integrated Management System consists of the systems of the profit centers i.e. programs/subsidiaries within Alkaloid, as follows:

• The Integrated Pharmaceutical Quality System in PC Pharmaceuticals is based on cGMP requirements for production and control of safe, efficient and quality medicinal products for human use, which are of high quality and on the international standards ISO 9001 and ISO 14001 and ISO 13485 for medical devices and HACCP for food safety (food supplements);
• The System for Quality, Environment and Food Safety in PC Chemistry, Cosmetics, Botanicals – the Botanicals Program is based on the requirements of HACCP and HALAL for food safety, cGMP (for herbal and traditional herbal products), international standards ISO 9001 and ISO 14001, EU 2092/91 Directive for organic production methods, Fair Wild version 2 for Fair Wild Collection and processing and marketing of wild plants products.
• The Quality System in PC Chemistry, Cosmetics, Botanicals – the Cosmetics Program is based on cGMP requirements (for cosmetics products), 1223/2009/EC Directive for production of cosmetic products and the international ISO 9001 and ISO 14001 standards;
• The Quality System in PC Chemistry, Cosmetics, Botanicals – the Program Chemistry - Medical Devices is based on requirements of ISO 13485 and ISO 9001 standards, as well as the 93/42/EEC European Medical Devices Directive, 2007/47/EC Directive and c MEDDEV guidelines;

  
  

• The Quality System in PC Chemistry, Cosmetics, Botanicals – the Chemistry program is based on ISO 9001 and ISO 14001 requirements;
• The Pharmaceutical Quality System in Alkaloid d.o.o Belgrade, Alkaloid Veledrogerija d.o.o Belgrade and Alkaloid Cons DOOEL is based on cGMP and international ISO 9001 and ISO 14001 standards.  

The Integrated Management System is a documented system of a process model with functional value within the overall Alkaloid AD policy. The important documents are as follows: the Alkaloid’s Integrated Management System Policy, that is closely related to the vision and mission of the company, the IMS Manual, the Environmental Master Plan, procedures, standard operating procedures (SOPs), instructions and other documents. Keeping customers, business partners, employees and shareholders satisfied and continuously improving the IMS is our objective.

INSPECTIONS AND AUDITS

The regular checks of the Pharmaceuticals, Chemistry, Cosmetics and Botanicals facilities by internal and external regulatory notified / certified bodies inspections, as well as second party audits by our customers and partners, pursuant to agreements, confirm the fact that the manufacturing processes - starting from the entry of the raw materials in the factory and ending with the final product as outcome - are carried out in accordance with the leading international norms.

The Drug Bureau at the Ministry of Health also conducts inspections, starting with all types of products or quality systems that refer to:

• ® production of drugs for human use for non-sterile oral solid dosage forms (tablets, capsules), cephalosporin dosage forms, liquid dosage forms for external and internal use, non-sterile and sterile semi-solid dosage forms, sterile small volume dosage forms;
• ® production of active pharmaceuticals substances
• ® production of herbal / traditional herbal drugs
• ® production of cosmetic products

In November 2007, Alkaloid – PC Pharmaceuticals was awarded a GMP Compliance Certificate by the Medicines and Healthcare Regulatory Agency-Great Britain, based on a GMP inspection of the facilities for production and control of solid pharmaceutical forms (tablets, film-coated tablets), in line with all the logistic operations and processes for quality assurance by inspection  services at the Ministry of Health in Great Britain. We take great pride in having this certificate confirmed in July 2010.

In November 2005, 2007, and 2011 as a result of the regular inspection by the law enforcement authorities of the Republic of Romania, Alkaloid - PC Pharmaceuticals confirmed that the production and control of drugs in the two factories of Alkaloid-Pharmaceuticals is performed in accordance with the highest standards for production of drugs, regulated by the GMP norms of the European Union, WHO and the Pharmaceutical Inspection Cooperation Scheme (PICS/s).

In May 2009, JAZMP – the Slovenian Medicines Agency conducted a successful inspection of the facilities for liquid dosage forms for external and internal use and, as a result of that, PC Pharmaceuticals was awarded a GMP Compliance Certificate for liquid dosage forms for drugs for human use.

In 2012 IAL – the Bulgarian Drug Agency confirmed the conformity of our solid dosage forms – capsules with the European GMP standards.

The new confirmation of the "Health Above All" commitment by Alkaloid AD is the HACCP certificate for production of safe food, awarded on 17.04.2007 to the Botanicals section for the entire production program: teas, additives, seasoning, dried vegetables, salt and "Zachinal" spice. The certification was performed by the renowned certification body Quality Austria. The HACCP (Hazard Analysis of Critical Control Points) is a proven system based on identification of hazards that are potential contaminators of food and on their monitoring, control and prevention, which results in production of safe food. The greatest benefit from the HACCP certificate is the pleasure of our consumers that they can have high quality and safe food.

The beginning of 2007 was marked by successful CE certification for manufacturing of X-ray films, awarded to PC Chemistry, Cosmetics and Botanicals – Chemistry program, in compliance with 93/42/EEC Directive, which is an evidence of the commitment to high quality of Alkaloid products. In May 2010 this success was confirmed by CE Certification of the dialysis solutions manufacturing by the eminent certification authority KEMA – Netherlands, in compliance with 93/42/EEC and 2007/47/EC Directive.

Audits from our partners, the so called customer audits, occur regularly: in September 2005, the American multinational company Pfizer, as a long-standing partner of choice for Alkaloid, and, in July 2006 and November 2010, the Swiss multinational company НOFFMANN LA ROCHE - a giant in the area of health care - both checked the production and control of drugs in Alkaloid - Pharmaceuticals and confirmed that the operations are compliant to the highest standards for manufacturing drugs regulated by the GMP norms of the European Union, the WHO and the Pharmaceutical Inspection Cooperation Scheme (PICS/s).

Audit of Botanicals facilities conducted in September 2010 by our buyer AVEDA – the world renowned manufacturer of herbal medicines and cosmetic products, supplier to Estée Lauder - resulted in highest ratings for Alkaloid. As a result of the inspection, our cooperation is expanding.

ISO certification audits are carried out every three years by the renowned certification authority Quality Austria, accredited by IQNet - The International Certification Network, but there are repeated audits each year to verify the conformity of the Systems for Quality and Environment of the profit centers with international ISO 9001 and ISO 14001 standards.

The certification of organic production methods is subjected to regular annual audits by the Control Union Certifications-Netherlands in compliance with EU 2092/91 Directive, The National Organic Programme of United States Department of Agriculture, and Organic JAS-Japanese Agricultural Standards.

One of the latest certificates is the “Fair Wild” Certificate which confirms that products in the group of teas are in compliance with the requirements of the fair trade principles (Fair Trade), ILO - International Labour Standards and ISSC - MAP - International Standards for Sustainable Wild Collection of Medicinal and Aromatic Plants). “Fair Wild” certified products confirm the fair relation between collectors of plants and the company – user of the wild plants collected. This standard also guarantees better working conditions for collectors of plants and employees of Alkaloid AD involved in the process of manufacturing “Fair Wild” certified products. The management of natural resources and sustainable use of medicinal and aromatic plants is an integral and particularly significant aspect of the “Fair Wild” standard. Thus, Alkaloid AD Skopje became a member of the group of few companies in the world certified in compliance with the principles of the new “Fair Wild” standard version 2(08/2010) and obtained the opportunity to place its products in the group of teas bearing the “Fair Wild” logo on all world markets.

In 2011 the Medical Devices Program was awarded the Certificate for management of the quality of medical devices in compliance with the 13485 standard.

In view of the application of GMP standards for automated computerized systems (GAMP), Alkaloid AD implemented a modern, completely validated, software solution - AlkaSAP in 2007. The SAP system is certified in compliance with ISO 9001. In 2014 the Human capital resource management module has been upgraded in the AlkaSAP system.

Since 2009, all documents are prepared in AlkaDMS – document management software.The upgrade with Expert modules in AlkaDMS (starting from 2014) means preparation of an entire life cycle of Alkaloid’s IMS documentation through AlkaDMS (Alkaloid’s Document Management System).

NOW...

In relation to GMP standards for automated computerized systems (GAMP), alongside the functioning of preparation of eCTD in AlkaDMS, the preparation and life cycle of IMS documentation of Alkaloid are in the stage of implementation, through AlkaDMS (Alkaloid’s Document Management System).

The humanistic and production orientation of Alkaloid AD, implemented by application of state of the art production technologies and business standards is regularly confirmed with checks of the Integrated Management Systems of Alkaloid.

Manufacturing of high quality, efficient and safe drugs by applying the Good Manufacturing Practice principles (GMP), for which the ALKALOID AD trademark is a symbol of high level of safety, is also proven during regular inspections by the relevant state inspection services from Macedonia and abroad.

ALWAYS... 

Permanent compliance to the standards, guidelines and directives, both as legal obligation and commitment to quality, safety and efficiency of all products of Alkaloid is all-pervading as it leads to our objective:

HEALTH ABOVE ALL..