Standards and controls

(cGMP, ISO 9001:2000, ISO 14001:2004)
(ISO 9001:2000, ISO 14001:2004, ЕU 2092/91, HACCP)
(ISO 9001:2000, ISO 13485)

Alkaloid, being a leader in the region and wider, was among the first companies which certified the Systems for Quality of the Profit Centers (Pharmaceuticals, Chemistry, Cosmetics and Botanicals), in accordance with the international standards ISO 9001, in the period 1997-1999.

The year 2000-2001, Alkaloid was already the first company in Macedonia awarded with certificates for Environment Systems that conform to the international standard ISO 14001 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 hard oral dosage forms, built in compliance with the world GMP requirements. Confirmation for this compliance is awarding the first GMP certificate that any of the Macedonian producers of drugs have ever been awarded with, by the Macedonian Ministry of Health. Alkaloid was also awarded with GMP certificate for the new factory for production or oral cephalosporins.

In March 2005, by the start of the new section for drugs packing Alkaloid confirmed the GMP Certificate for Good Manufacturing Practice from the Macedonian Ministry of Health compliant to the EU Directives and Main Guidelines of the WHO. During the same year, the new microbiology laboratory became operational while the other laboratories for Quality Control were refurbished.

Starting 1998, the Botanicals program was verified with the first certificate in organic production methods as compliant with the EU Directive 2092/91 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.

Development and improvement of the standards and guidelines results in integration and continuous improvement of the Systems for Quality and Environment of the profit centers in Alkaloid. In this way, the System for Quality and Environment of the PC Pharmaceuticals is based on the GMP and the International Standards ISO 9001 and ISO 14001 requirements. The system for quality and environment in the PC Chemistry, Cosmetics and Botanicals, the program Botanicals is based on the Standards ISO 9001 and ISO 14001 requirements, as well as the ЕU Directive 2092/91 for organic production methods and requirements for HACCP according to the international standard ISO 22000.

The System for Quality and Environment Protection is a documented system for process model with functional value in the frames of the overall policy of Alkaloid AD. The most important documents are the Policy for Quality and Environment that is closely related with the mission and vision of the company, the Rules and Procedures for Quality and Environment, The Master Plan on the Environmental Aspects, procedures and other documents.

Our Rules and Procedures for Quality and Environment are a summary of procedures and other documents of essential value for regular functioning of the profit center. They apply to all activities of the main process, as a unified system of interrelated procedures that meet the goals set for this organization.
The decisions in our company are made on the basis of analysis of customers' needs, precise measuring of the features of our products, processes, environmental aspects, in order to satisfy the consumers, business partners, employees and shareholders, as well as continuous improvement of the System for Quality and Environment.

CONTROLS

Confirmation of the fact that the total manufacturing process, starting from the entry of the raw materials in the factory until the final product as outcome, is carried out in accordance with the international norms that are in force for pharmaceutical products manufacturing. This includes regular checks of the Alkaloid-Pharmaceuticals facilities by external pharmaceutical law enforcement inspections.

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

Related to application of preparations to be sold on the Bulgarian market, the operating of Alkaloid, in April 2005 was re-checked by the Drugs Agency of the Republic of Bulgaria which reconfirmed again the complementarity of the factories for hard dosage forms and semi-synthetic cephalosporines with the European norms for DPP.

In September 2005, the American multinational company Pfizer, as a long-period partner of choice for Alkaloid, and, since July 2006 also the giant in the area of health care - the Swiss multinational company НOFFMANN LA ROCHE both checked the production and control of the drugs in Alkaloid-Pharmaceuticals and confirmed that the operations are compliant to the top standards for manufacturing drugs regulated by the norms for the DPP of the European Union, the WHO and the Cooperation Scheme of the Pharmaceutical Inspection (PICS/s).

In December 2005, the Agency for Food and Drugs of the Kingdom of Jordan inspected the factories for hard dosage forms and semi-synthetic cephalosporins and issued GMP certificates to both factories of Alkaloid-Pharmaceuticals.

In August 2006 our buyer Macizapharma Russia checked the conformity with the GMP standards and their evaluation in the report was that the "company Alkaloid AD is very good and modern company, with modern manufacturing facilities and equipment, has highly qualified staff and conforms to all EU GMP requirements ".

In March 2006 a Pre-approval FDA GMP inspection was carried out by Beckloff Associates - USA, which resulted with suggestions for improvement in order to implement the FDA requirements part 210, 211, 11 and preparation for control to be carried out by the FDA GMP inspection.

The ISO certification audits are carried out every three years but each year we undergo repeated audits for verifying the conformity of the Systems for Quality and Environment of the profit centers with the international standards ISO 9001 and ISO 14001.

NOW...

The end of 2006 and beginning of 2007 was a period of introducing a modern software solution - AlkaSAP as basis for providing long term quality of the products. The SAP system is certified according to ISO 9001:2000.

The beginning of 2007 was marked by the successful CE certification for manufacturing X-ray films by the PC Chemicals, in accordance with the ISO 13485 standard and the Directive 4993/42/EEC, which is an additional evidence of our commitment for high quality products of ours.

The new confirmation for the "Health Above All" commitment by Alkaloid AD is the HACCP certificate for production of safe food, awarded on 17.04.2007 to the section Botanicals for the entire production program: teas, additives, seasoning, dried vegetables, salt and "Zachinal" spice. The certification was performed by the famous certification body ÖQS, Quality Austria.

The HACCP (Hazard Analysis of Critical Control Points) is a proven system that is based on identification of hazards that are potential contaminators of the food, their monitoring, control and prevention, which results in production of safe food. The greatest advantage from the HACCP certificate is the pleasure of our consumers that they can have high quality and safe food.

The humanistic and production orientation of Alkaloid AD, implemented with application of state of the art production technologies and business standards also in the Profit Center Pharmaceuticals, was confirmed these days during the regular check of the System for Quality Management, process oriented and compliant to ISO 9001:2000, integrated into the System for Environmental Management compliant to ISO 14001:2004, performed by the Certification Body ÖQS, Quality Austria.

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

SOON...

For PC Pharmaceuticals, expected soon is the inspection by the inspection services from the UK Ministry of Health.

The plans for distribution of the drugs on the US market bring new challenges for implementation of the FDA requirements part 210, 211, 11 and expectations for controls by the FDA GMP inspection.

ALWAYS...

The permanent compliance to the standards, guidelines and directives, as legal obligation and commitment for quality is a permanent orientation of Alkaloid.

Documents related to this content:

IQNet ISO 14001 2005

Quality Management System ISO 9001 : 2000