INSPECTIONS AND AUDITS
The regular audits of the Pharmaceuticals, Chemicals, Cosmetics and Botanicals plants by national and external legal inspection services/certified /notified bodies, 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 Macedonian Agency for Medicines and Medical Devices (MALMED) performs regular checks for compliance with the good production practice of the quality system and the plants for:
• production of drugs for human use for non-sterile oral dosage forms (tablets, capsules, etc), 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 drugs to be used in cosmetology
In November 2007, Alkaloid – PC Pharmaceuticals was awarded for the first time a GMP Compliance Certificate by the Medicines and Healthcare Regulatory Agency-Great Britain, based on a GMP inspection of the production facilities and control of solid pharmaceutical forms. Since then, Alkaloid – PC Pharmaceuticals, based on the regular inspections by the JAZMP (Agency for Drugs and Medical Devices of the Republic of Slovenia) maintains the EU GMP compliance certificates for the two locations on Blvd. Aleksandar Makedonski no.12 and Blvd. Partizanski odredi No. 98A (last inspection 23-27.09.2019).
In January 2018, the FBU "GILS and NP" inspection of the Ministry of Industry and Trade of the Russian Federation awarded Alkaloid AD Skopje - PC Pharmaceuticals with GMP Certificates, for the two locations on Blvd. Aleksandar Makedonski no.12 and Blvd. Partizanski odredi No. 98A, which is a significant success. Renewal of the Certificates was made by conducting inspection of the production plants on Blvd. "A. Makedonski No. 12" on 17-20.11.2020 and the production plants on Blvd. "Partizanski Odredi" No. 98A on 23-25.11.2020, which resulted with a positive outcome.
Audits from our partners, the so called customer audits, are performed regularly because Alkaloid AD Skopje - PC Pharmaceuticals produces medical products for about 30 well-known multinational companies. The Chemicals program also has regular audits from several renowned multinational companies.
The Botanicals program has regular audits by world famous buyers from USA.
Additionally, the Orthodox Union (OU) conducts annual inspections in the Botanicals Program (for products – teas) for Kosher products, as well as inspections by the Gluten Free Certification Organization for gluten-free contract products for our customer from the USA.
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, Environment and Safety of the profit centers with international ISO 9001, ISO 14001and ISO 45001 standards.
The certification of organic production methods is subjected to regular annual audits by the EU Regulation (EEC) No. 834/2007, 889/2008 on organic production of agricultural and aquaculture products and indications referring thereto on agri-cultural and aquaculture products and foodstuffs, including amendments i.e. the National Organic Program of United States Department of Agriculture 7CFR 205 and Organic JAS-Japanese Agricultural Standards MAFF Japan by Control Union Certifications B.V.
In July 2018, Alkaloid AD Skopje - Botanicals Program was awarded with the FSSC 22000 certificate for the production of teas (one-component and multi-component teas). The certification was carried out by the renowned certification body Quality Austria.
The FSSC22000 certification is a confirmation that the food safety system within the Botanicals Program for production of tea meets the requirements of the global retailers and the big brand food companies under the only internationally recognized food safety management system of the Global Food Safety Initiative. (GFSI). Alkaloid AD Skopje - Botanicals Program implemented the FSSC22000 certification emphasizing its commitment and guarantee for the quality and safety of the teas it produces for the consumers around the world.
In the period from 29 until 31 July 2019, the US Food and Drug Administration - FDA conducted inspection in the Botanicals Program, after which Alkaloid AD Skopje was successfully included in the group of approved companies in the world by the FDA that meet U.S. requirements under Federal Food and Drug Act.
With this, Alkaloid AD Skopje once again confirmed its commitment to the permanent development, the following of the international trends and the fulfillment of the strict regulatory requirements of GMP 21 CFR 117 Subparts A and B; CP7321.008 "Dietary Supplements - Import and Domestic" and CP7321.005 "NLEA, Nutrient Sample Analysis and General Food Labeling Requirements - Domestic and Import", which are key to obtaining quality and safe nutritional supplements.
In regards to 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 accordance with ISO 9001. In 2014, the human resources management module has been upgraded in the AlkaSAP system. In 2020, the platform was upgraded to S4HANA.
In 2009, the development of documentation in AlkaDMS (Alkaloid Document Management System) - document management software has been initiated.
Validation software for the equipment and instruments, which ensures high level automated operation and data integrity, is used in Production, Quality Control and Service.
In views of the GMP standards for automated computerized systems (GAMP), improvements for all modules in AlkaSAP and upgrade of AlkaDMS for electronic control of processes and documents at a higher level are in a stage of implementation.
The humane, program-production orientation of Alkaloid, realized by applying the cutting-edge production technologies and business standards, is regularly confirmed with checks of the Integrated Management Systems of Alkaloid.
The production of quality, effective and safe drugs, by applying the principles of Good Manufacturing Practice (GMP), for which the trademark of ALKALOID AD Skopje is a symbol of a high level of safety, is confirmed by regular inspections by competent state inspection services from the Republic of Macedonia and abroad.
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.